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Date Job Title Job Level Location
2/17/20 Medical Director, Respiratory and Allergic Diseases Individual contributor South San Francisco, California

Roche/Genentech is seeking a Medical Director/Senior Medical Director to participate in the clinical development of a novel agent entering Phase III development for idiopathic pulmonary fibrosis. The role involves clinical representation on cross-functional teams responsible for the design, implementation, medical monitoring, data interpretation, reporting and publishing of studies. It will also include working with internal partners in the completion and submission of regulatory filings and supporting other regulatory processes. Additional responsibilities will involve collaboration with Research and with external partners including clinical investigators, clinicians, scientists and experts in the field. 

Key Accountabilities:

Assisting in the overall management, planning, evaluation and documentation of projects and studies.

Participation in on-going medicine development activities including:

  • Lead the clinical support across all relevant studies and support the Global Development Lead and overall team with cross-functional integration, coordination and alignment to enable effective clinical development execution.
  • Maintain the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
  • Act as medical monitor on clinical trials
  • Monitor and review data
  • Preparation of regulatory documents and interaction with global regulatory authorities
  • Analysis, presentation and interpretation of studies and published data
  • Interactions with health authorities and expert bodies
  • Close collaboration with drug safety, regulatory affairs, medical affairs and clinical trial operations
  • Participation in the preparation of abstracts, posters and presentations for scientific meetings and congresses
  • Developing and writing clinical plans and protocols ensuring that they are scientifically sound

QUALIFICATIONS & EXPERIENCE:

  • M.D. with relevant fellowship training in Pulmonary/Respiratory.
  • Candidates with 2 or more years pharma/biotech industry experience in Pulmonary who do not have fellowship training in Pulmonary will also be considered.  
  • Academic background is a plus.
  • Experience working with the principles and techniques of data analysis, interpretation and clinical relevance.
  • Versed in medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations.

ABILITIES:

  • Has impeccable ethics. Demonstrates, or proven abilities to demonstrate, Roche Values.
  • Outstanding attention-to-detail.
  • Excellent project management skills: can prioritize multiple tasks and goals.
  • Good interpersonal, verbal and written communication skills.
  • Works well within teams and is effective in collaborating with others internally and externally.
  • Ability to travel globally (<30%).
2/17/20 Associate Director IT Manager with direct reports South San Francisco, California

Are you up for the challenge to enable a high performing team in a very dynamic and diverse environment? Not only will you inspire the internal team, but also establish strong partnerships with other IT leaders globally to ensure that services are delivered optimally across organizational and regional boundaries for our consumers.

The incumbent will report to the Head Application Services and be responsible for managing the global Collaboration, Publishing and Document Management team (CP&DM).  As line manager you are expected to create and maintain a great team spirit, focusing both on innovation, project and high quality service delivery.

Our solutions are focused around the cSuite which include Google Apps for business suite, Trello and other solutions supporting business in new ways of working. 

You will:

  • Work closely with the Integrated Service Owner for both Meeting Experience and Individual and Team Productivity to deliver on the overall strategy and roadmaps. 
  • Be a leader of leaders and at the same time be community lead for all application services team members in Genentech. 
  • Be a senior leader for GIS in Genentech and take broad responsibilities for GIS on this site to support the community and connect with the local leadership. 

Key responsibilities include: 

  • Best-practice leadership is applied throughout the organization and ensure that core values are lived in the team.

  • Team members feel engaged, motivated, and hold opportunities to develop themselves.

  • Oversee that all our IT work processes are executed in a customer- and service oriented manner.

  • A spirit of change with passion is maintained throughout the team.

  • Goals and development plans are completed, discussed and agreed on-time in your organization. 

  • Effective coaching direct reports is a given and you ensure that your managers also provide good coaching and development for their team members. 

  • Individual Development Plans for all employees are in place and updated

  • Set priorities for team and support in accomplish objectives. 

  • Support Integrated Service Owners with strategic input from the functional delivery side.

  • Accountable for the team fulfilling security and data privacy requirements also when dealing with cloud solutions.

  • Accountable for the team budget.

  • Accountable for supplier contracts and budgets established within the team. 

Community Lead responsibilities:

  • All employees feel a part of AS at the local site.

  • Focus on people & culture: building engagement, development, connecting across partner IT organizations at local site.  

  • Promote AS services in Genentech.

  • Support service orientation at local site.

  • Admin manager for other AS team members in local site with global reporting lines.

Who you are:

You’re someone who wants to influence your own development and can lead the performance and development of teams and individuals around you. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies.

Minimum qualifications:

  • Bachelor's degree or equivalent in computer science, information technology or business information systems or related fields is preferred. 

  • At least 8 years experience in leading global and virtual teams.

  • Proven ability to establish high performing teams with a focus on individual development of team members. 

  • Experience in working with near- or off-shored service providers for development and operational activities required.

  • Strong influencing and stakeholder management skills.

  • Flexibility to work during hours that allow for meetings with colleagues in Europe 2-3 times per week. 

  • Around 20% travel time across the year should be expected.

  • Prior experience working with security, legal, data privacy governance of cloud based tools within a global enterprise. 

  • Passion for technology with the ability to comprehend complex technical and business issues and assess, evaluate and articulate options and solution.

  • Product Management/Marketing experience, including weighing and balancing multiple competing requests, is highly preferred.

  • Fluency in English (verbal and written).

#LI-CGPK1

2/15/20 Intern - Research and Early Development Human Resources Client Management Entry Level South San Francisco, California

Length: Summer, 3 months

Targeted Start date: June 2020

Department Overview:

The Human Resource Business Partnering (HRBP) group supporting Genentech's Research and Early Development (gRED).

Responsibilities/Project Overview

The Genentech Research and Early Development (gRED) Human Resource Business Partnering (HRBP) Team has a 3 month internship opening starting in June. We are seeking an intern to support the following areas:

 

Information Management:

  • Project manage by partnering with gRED communications and People and Organizational Development (P&OD) to create or revise data information systems for gREDHR including: Internal pages on gRED’s site pertaining to HR.
  • Enhance the gSite used for the external team by conducting research to determine what else might be useful/ needed
  • Other Information management support, as identified
  • Actively engage on People and Culture Initiatives:
  • Research what exists external to gRED (across other parts of Genentech) and external to Genentech in the areas of cultural norms and diversity and inclusion (D&I) best practices
  • Develop creative proposals to compliment the work underway (ex: Pop-up events on campus, developing a sound list of known/ respected speakers to come and present to gRED, the use of social media to “brand” our people and culture tenants, etc.).
  • Plan event and logistics for any proposals that get endorsed including pre-event communications, outreach to appropriate populations including, DNA groups, agenda development, and other presentation responsibilities as needed
  • Other project support as opportunities are identified

Tactical Support:

  • Manage ongoing project work via google suite and leveraging support from partners as necessary
  • Organize notes post meeting and prioritize outcomes/ next steps
  • Create and or redesign Powerpoint presentations
  • Other organizational and tactical support as needed

Preferred Qualifications

  • Excellent interpersonal and relationship building skills
  • Strong, positive communication skills (written, oral, listening and presentation) to a variety of audiences including entry-level through senior leadership
  • Strong aptitude for detail orientation and timely completion of work
  • Must be empathetic and highly interested in improving employee experience
  • Proficiency/familiarity in Workday – training will be provided
  • Prefer biotech/pharm background
  • Highly proficient in the use of office systems, personal computers, Excel, PowerPoint, Google apps
  • Solid problem-solving skills and ability to work in a fast paced, complex, deadline-driven environment with multiple priorities
  • Should have some knowledge and have interest in, people and culture initiatives including: employee experience, inclusion and belonging, and the overall employee growth and development experience
  • Must have the ability to prioritize high volume and high priority tasks and business requirements
  • Must be able to work independently as needed without supervision



Education

  • Minimum Bachelor’s degree or in process of obtaining a Bachelor’s degree (Junior or Senior), preferably in: Human Resources, Communications, Business or equivalent experience. Masters degree candidates also encouraged to apply

2/15/20 Process Development Scientist, Analytical Development (iNeST) Individual contributor South San Francisco, California

The Process Development Scientist, Analytical Methods (iNeST) is part of the Individualized NeoAntigen-Specific Immunotherapy team in the Pharma Technical organization (PT-iNeST) based in South San Francisco. iNeST is an RNA-based individualized cancer immunotherapy.

In this role, the Process Development Scientist, Analytical Methods (iNEST) will ensure relevant analytical methods are developed, validated and implemented from early development through product licensure. Responsibilities will include characterization, method development and qualification, supporting process development, release and stability testing of novel drug substance and drug products. The Process Development Scientist, Analytical Methods (iNEST will report to the Analytical Lead and interact closely with the dedicated, cross-functional iNeST team members in South San Francisco, Hillsboro, and Basel, as well as with our collaborators in Germany.

Main responsibilities

  • Development and qualification of release, stability and characterization assays needed to support process development, clinical and commercial manufacturing
  • Design, execution and analysis of experiments to support process development activities within the PTD labs. Presentation of results to cross-functional teams and corporate partners
  • Support the implement of a novel control strategy for iNeST to enable high quality control (QC) throughput and minimum turnaround time for product release
  • Author technical reports in support of analytical development and process development activities
  • Support analytical method validation and transfers to commercial manufacturing site(s).
  • Collaborate and/or author sections of documents to be reviewed by health authorities (e.g. INDa, IMPDa, BLA)

Who You Are

  • PhD, Bachelor or Master degree in chemistry, biochemistry, chemical engineering or a related discipline and 8 - 10 years relevant experience in the pharmaceutical industry within analytical development.
  • Candidates must have a strong background in protein analytical chemistry, experience in chromatography (HPLC, UPLC), capillary electrophoresis, mass spectroscopy, and/or other analytical techniques.
  • Experience with individualized therapies or in field of RNA therapeutic products a strong plus.
  • High flexibility and strong problem solving skills to meet business objectives. A ‘can-do’ attitude, with the ability to deal with ambiguity and to “think out of the box” and challenge the status quo
  • Demonstrated ability to independently manage complex situations as well as to coordinate multiple tasks and manage priorities
  • Strong verbal and written communication skills including the ability to present scientific results clearly and concisely
  • A strong desire to work in a collaborative, multi-disciplinary environment; demonstrated ability to effectively interact in small teams.
  • Customer-focused, motivated, detail-oriented, with excellent organizational skills
  • German language proficiencies (verbal and written) a plus
  • This position requires up to 10% international travel
2/15/20 Process Development Senior Research Associate, Analytical Development (iNeST) Individual contributor South San Francisco, California

The Process Development Senior Research Associate, Analytical Methods (iNeST) is part of the Individualized NeoAntigen-Specific Immunotherapy team in the Pharma Technical organization (PT-iNeST) based in South San Francisco. iNeST is an RNA-based individualized cancer immunotherapy.

In this role, the Process Development Senior Research Associate, Analytical Methods (iNEST) will ensure relevant analytical methods are developed, validated and implemented from early development through product licensure. Responsibilities will include characterization, method development and qualification, supporting process development, release and stability testing of novel drug substance and drug products. The Process Development Senior Research Associate, Analytical Methods (iNEST will report to the Analytical Lead and interact closely with the dedicated, cross-functional iNeST team members in South San Francisco, Hillsboro, and Basel, as well as with our collaborators in Germany.

Main responsibilities

  • Development and qualification of release, stability and characterization assays needed to support process development, clinical and commercial manufacturing
  • Design, execution and analysis of experiments to support process development activities within the PTD labs. Presentation of results to cross-functional teams
  • Support the implement of a novel control strategy for iNeST to enable high quality control (QC) throughput and minimum turnaround time for product release
  • Author technical reports in support of analytical development and process development activities
  • Support analytical method validation and transfers to commercial manufacturing site(s).

Who You Are

  • PhD, Bachelor or Master degree in chemistry, biochemistry, chemical engineering or a related discipline and 5 to 7 years relevant experience in the pharmaceutical industry within analytical development.
  • Candidates must have a strong background in protein analytical chemistry, experience in chromatography (HPLC, UPLC), capillary electrophoresis, mass spectroscopy, and/or other analytical techniques.
  • Experience with individualized therapies or in field of RNA therapeutic products a strong plus.
  • High flexibility and strong problem solving skills to meet business objectives. A ‘can-do’ attitude, with the ability to deal with ambiguity and to “think out of the box” and challenge the status quo
  • Strong verbal and written communication skills including the ability to present scientific results clearly and concisely
  • A strong desire to work in a collaborative, multi-disciplinary environment; demonstrated ability to effectively interact in small teams.
  • Customer-focused, motivated, detail-oriented, with excellent organizational skills and the ability to manage priorities.
  • German language proficiencies (verbal and written) a plus
  • This position requires up to 10% international travel
2/14/20 Intern - Research and Early Development - Structural Biology Entry Level South San Francisco, California

Start Date: Summer 2020

Work Hours: 40 hours per week 

Location: South San Francisco Campus

Length of Assignment: 3 months 

Education Level: Master of Science (1st or 2nd Year or recent grad) OR PhD Student (pursuing PhD, not completed)

Preferred Majors/Specializations: structural biology, computer science, biophysics or related disciplines

Intern Qualifications: Experience in scientific software development, and/or cryoEM image processing, and/or scripting (Python, javascript, or C++).

Department Overview: The Structural Biology group collaboratively advances drug discovery through understanding of the structure, function and regulation of proteins of therapeutic interest. Focus areas include: X-ray crystallography, NMR spectroscopy, CryoEM, and biophysical characterization and analysis of protein targets.

Project Description: Depending on the successful candidate's expertise and interests, responsibilities might include: benchmarking and optimizing alternative cryoEM image processing workflows, integrating information management software with automated data collection and processing software, developing improved algorithms for automated image processing, and/or implementing new features in existing image processing software.

2/14/20 Intern - Site Services Facilities Operations and Maintenance Entry Level South San Francisco, California

Duration:

Summer - 10-12 weeks

Target Start Date: 6/16/2020

Target End Date 9/18/2020

Overview: This internship opportunity is to SSF Facilities Operations and Maintenance team, primarily managing the South San Francisco Mid Campus operations.

Responsibilities
  • Update engineering drawing,
  • Standardize FDH (Facilities Data Historian) alarm descriptions
  • Assign equipment alarm response instructions in FDH
  • Improve work order efficiency through Mobile Maintenance Rounds

Qualifications
  • Must be 3rd or 4th year engineering student.
  • Knowledge overview of building infrastructure and support systems including utility distribution systems, gases, HVAC or similar systems.
  • Must be independent worker and self-starter and motivated to work with a team Candidate must have good organizational, verbal and written communication skills.
  • Possess an intuitive sense for working safely in a potentially risky environment.
  • Ability to read and understand system drawings and P&ID`s associated with utility systems.
  • Computer Skills: CMMS(SAP), Microsoft Office Suite

2/14/20 Intern - Personalized Healthcare PHC Imaging Group Computer Vision/Deep Learning Entry Level South San Francisco, California

Computer Vision/Deep Learning Internship

Length: Summer Internship

Targeted Start Date: May 2020

Targeted End Date: August 2020

Description:

The PHC Imaging Group at Genentech has several summer data internship opportunities to contribute to the development of CV/DL algorithms applied to medical imaging. In this internship, you will be working on CV/DL tasks (eg., Texture Analysis, Image Processing, Nonlinear Transformations and Registration, and Sparse Segmentation) in a specific disease area/modality (oncology, neuroscience, ophthalmology, or digital pathology). You will have the unique opportunity to develop and apply CV/DL-based methods on very large data sets of 3D/2D clinical images (CT, MRI, OCT/CF) and/or gigapixel histo/cytopathology digital scans. With potential for significant impact on disease assessment, the developed methods will be used to predict clinical outcomes (prognosis) for patients and to guide the evaluation of therapeutic efficacy.



Requirements:

The successful candidate will use skills and training acquired across areas such as EE/CS, statistics, mathematics and/or physics. Strong experience in Python, Matlab or R, and familiarity with scientific computing environments (cloud computing/AWS, HPC) and Deep Learning frameworks (e.g., TensorFlow, PyTorch, Keras), are required for the internship. Experience with medical imaging data format (DICOM) a plus.



The PHC Imaging Group members have deep backgrounds across medical imaging,

physics, computer science, mathematics, statistics, and genetics. Our team works

closely with clinical experts to design medical imaging solutions to improve patient care.

Qualifications:

The successful candidate will be working on a science degree (preferably in a relevant field) at the Master's or PhD level.

2/14/20 Postdoctoral Research Fellow - Discovery Oncology, Yauch Lab Individual contributor South San Francisco, California

We are seeking a highly motivated and independent postdoctoral research fellow to work in the area of cancer cell biology within the Discovery Oncology department. Research projects in our lab would be focused on the identification and functional characterization of novel genes that are necessary for cancer cell viability.  Candidates will have access to state-of-the-art proteomic, genomic profiling and genetic engineering facilities to aid in their research.   

Requirements:

The successful candidate will have a PhD in the life sciences, accompanied by a productive track record that should include first-author publications in high-quality journals. Prior experience in cancer cell biology is a plus. Candidates should be proficient in basic molecular biology, biochemistry and protein chemistry skills, including gene manipulation approaches such as RNAi and/or CRISPR. Computational skills to enable analysis of high dimensional data are highly desirable. Excellent oral and written communication skills are required.   

For more information about our postdoctoral program, please visit: http://www.gene.com/careers/academic-programs/postdocs

For more information about the lab of Bob Yauch, please visit:

https://www.gene.com/scientists/our-scientists/bob-yauch

2/14/20 Medical Director, Product Development Oncology (Entrecinib / TAPISTRY) Individual contributor South San Francisco, California

Roche’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase II – IIIA) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients. The Associate PD Medical Director participates in development of the Clinical Development (CD) strategy and plan and helps ensure effective and efficient CD plan execution for the assigned molecule(s)/indication(s). Associate PD Medical Directors participate in health authority (HA) interactions with supervision from more experienced PD Medical Directors.



1. Cross-Functional Team Membership

• Participates in the relevant Clinical Science Team (CST)

• Participates as a standing or ad hoc member in sub-teams (e.g., Study Management Teams) relevant to assigned molecule(s)/indication(s) and supports the CST lead and overall team with cross-functional integration, coordination and alignment to enable effective and efficient CD plan execution

• As requested, supports the CST lead and overall team with training new CST members

• May also, as appropriate, support relevant sub-teams in training new team members



2. Global Clinical Development Planning

• Stays abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s)

• As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects

• Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment

• Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and key opinion leaders (KOLs), as well as multidisciplinary internal groups, including other groups in PD, research, regulatory, business development, commercial operations, legal, etc.

• Participates in CD strategy development

• Supports other CST members with development of clinical science information for inclusion into annual and strategic Lifecycle Plans (LCPs) and the Integrated Development Commercialization Plan (IDCP)

• May participate in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to provide clinical science development input and guidance. Includes reviewing Phase I protocols and providing CD input into these

• Supports internal partners in transitioning new drugs/indications into Phase IIIB or publication studies. May review Phase IIIB protocols and other information and provide CD input

• As assigned, may also consult to pharma partnering on relevant acquisitions, joint ventures or other strategic partnerships, as these potentially relate to the assigned therapeutic/disease area(s)

• Participates in development of the CD plan for assigned molecule(s)/indication(s) and/or other programs to include gathering and analyzing data and information necessary to create the CD plan, working with other CST members and relevant sub-teams to develop CD plan components (e.g., analytics/data strategy, KOL development, publications strategy, etc.) and working with CST and other relevant teams to develop and provide information and input for budget/resource requirements necessary to implement and execute the CD plan

• Supports other CST members in preparing for HA meetings. As appropriate, participates in HA meetings. Ethically, effectively and professionally represents the interests of Roche and patients

3. Clinical Development Plan Implementation

Provides clinical support across all relevant studies and programs:

• Participates in ongoing CST and relevant sub-team meetings, except Development Working Group (DWG), other interactions and communications

• Designs and develops clinical studies for review and discussion with other CST members

• May collaborate with others in the development of the product safety profile

• Collaborates with others in development of clinical sections of investigator brochures, presentations and other materials

• May participate in the identification and selection of appropriate external investigators and sites

• May assist others with patient registry design and development (including strategies for patient registry recruitment)

• Collaborates with others in development of study analytics and data management plans

• Participates in investigator and other external presentations, meetings and other communications

• May support clinical operations, clinical research organizations (CROs), etc. by acting as a point-of-contact for questions, other communications, and interactions

• Acts as a medical monitor for assigned studies

• Conducts ongoing reviews of medical/safety data

• Collaborates with relevant teams and other groups to measure and monitor study progress against objectives and plans, including any variances, and proactively communicate any issues, challenges and potential strategies to resolve such

• Supports, as needed, completion of interim study reporting

• Works closely with other CST members and clinical operations to close-out clinical studies, secure data and complete study reporting

• Reviews study data to ensure correct medical/scientific data interpretation for interim and final study reporting

• Participates in the development and implementation of communications strategies to support existing and concluded studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials

• Works with other CST members, regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation. Supports others with clinical science information and input for regulatory submissions and other regulatory processes. Includes developing label and packaging language, etc.

• Develops presentations for other CST members to deliver to convey the CD perspective and provide updates on strategies, plans and other activities

• Works with other CST members in ongoing data generation to address unmet medical needs and identify new or extended CD studies or other programs in the relevant therapeutic area of assignment

• Completes other special projects, as and when assigned, or otherwise requested

• Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures (SOPs) and other guidelines

QUALIFICATIONS & EXPERIENCE:

• M.D. with relevant medical experience in same/similar therapeutic area required

• 2 or more years pharma/biotech industry experience OR is a recognized expert in the field

• 2 or more years experience with clinical trials across Phase II – III drug development

• Academic/teaching background is a plus

• Experience working with the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)

• Experience developing product and safety profiles

• Versed in medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations

ABILITIES:

• Has impeccable ethics. Demonstrates, or proven abilities to demonstrate, Roche Values

• Outstanding attention-to-detail

• Has working knowledge of the multi-disciplinary functions involved in a company’s drug development process, e.g. clinical operations, biostatistics, regulatory, commercial operations, etc.

• Excellent project management skills: can prioritize multiple tasks and goals and ensure the timely, on-target and within-budget accomplishment of such

• Good interpersonal, verbal communication and influencing skills; can influence without authority

• Strong written communication skills

• Good business presentation skills; is comfortable and effective when presenting to others, internally or externally

• Good negotiation skills: knows how to complete deliverables by working effectively with others internally and externally

• Good judgment and decision-making skills; knows how to make trade-off decisions while balancing ethics and efficacy

• Works well within teams and is effective in collaborating with others internally and externally

• Ability to travel globally (<30%)

2/14/20 Clinical Scientist - Product Development Oncology (TAPISTRY) Individual contributor South San Francisco, California

Roche’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase II – IIIA) clinical strategies and plans to deliver medically-differentiated therapies that provide meaningful improvement to patients. The PD Clinical Scientist participates in development of the Clinical Development (CD) strategy and plan and supports the assigned PD Medical Director/Clinical Development Physician(s) with various deliverables necessary for effective and efficient CD plan execution for the assigned molecule(s)/indication(s). PD Clinical Scientists have primary responsibilities for supporting PD Medical Directors/Clinical Development Physicians with clinical documentation, representing CD on various sub-teams or other appropriate forums, supporting training of study site personnel, acting as a primary point-of-contact for questions and inquiries to CD regarding CD studies or other programs, conducting ongoing medical/safety data reviews, and providing clinical science inputs into study reporting. PD Clinical Scientists are expected to perform their responsibilities independently. PD Clinical Scientists are likely to have regular external interactions with cooperative groups, key opinion leaders (KOLs), external vendors supporting the work of CD, etc. They may also, alongside the PD Medical Director/Clinical Development Physician, participate in external interactions with health authorities (HAs).

PRIMARY DUTIES AND RESPONSIBILITIES:



1. Cross-Functional Team Leadership & Management

• Participates in the relevant Clinical Science Team (CST)

• Represents CD in sub-teams (e.g., Study Management Teams) relevant to assigned molecule(s)/indication(s), except the Development Team (DT). As needed and appropriate, addresses CD study or other program-specific questions; provides updates; delivers presentations; etc. May act as the lead CD representative on sub-teams

• As requested, or otherwise appropriate, trains new CST members

• May also, as appropriate, support relevant sub-teams in assigning and training new team members

• As appropriate, participates in ongoing enhancements/development of team processes, structures, systems, tools and other resources

• As appropriate, coaches and guides less experienced Clinical Scientists

• Where applicable, may manage one or more direct reports and is, in such instances, responsible for hiring, training, developing and retaining talent on his/her staff. Consistently complies with all governing employment laws, regulations and company HR policies & procedures

2. Global Clinical Development Planning

• Stays abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s)

• As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects

• Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment

• Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and KOLs, as well as multidisciplinary internal groups, including other groups in PD, research, business development, commercial operations, legal, etc.

• May participate in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to provide clinical science input and guidance. Includes reviewing Phase I protocols and providing CD input into these

• Supports internal partners in transitioning new drugs/indications into Phase IIIB or publication studies. May review Phase IIIB protocols and other information and provide CD input into these

• Expected to make important contributions to the CD strategy for the relevant therapeutic/disease area(s)

• Participates, alongside PD Medical Directors/Clinical Development Physicians, in the development of clinical science contributions into annual and strategic Lifecycle Plans (LCPs) and the Integrated Development Commercialization Plan (IDCP)

• Develops the CD plan with the PD Medical Director/Clinical Development Physician for assigned molecule(s)/indication(s) and/or other programs Gathers and analyzes data and information necessary to create the CD plan. May also delegate such research and analysis to less experienced Clinical Scientists

• Supports PD Medical Directors/Clinical Development Physicians by providing additional guidance and direction to CSTs and other relevant teams in developing all CD plan components (e.g. analytics/data strategy, KOL development, publications strategy, etc.)

• Where applicable and assigned, supports PD Medical Directors/Clinical Development Physicians in providing other groups with information and input into budget/resource requirements necessary to implement and execute the CD plan

• Supports PD Medical Directors/Clinical Development Physicians in preparing for HA meetings. As appropriate, participates in HA meetings. Ethically, effectively and professionally represents the interests of Roche and patients

3. Clinical Development Plan Implementation

• Provides strategic clinical science support for assigned studies and programs:

• Leads or otherwise participates in ongoing CST and relevant sub-team meetings, other interactions and communications

• Develops innovative clinical study designs for review and discussion with PD Medical Directors/Clinical Development Physicians and/or Global Development Leaders (GDLs)

• Conducts appropriate literature searches

• Collaborates with clinical operations, other groups and PD Medical Directors/Clinical Development Physicians to develop consistent language and criteria for the Informed Consent Form (ICF), protocol eligibility, protocol dose modification, protocol safety, Case Report Forms (CRFs), CRF instructions, etc. Helps coordinate consistent use of language and criteria across multiple Roche teams and projects (includes partner studies)

• Reviews and/or writes additional clinical science documentation and/or clinical science input into other documentation managed by other Roche groups (e.g., protocol summaries, safety monitoring plans, process documents, investigator brochures, etc.)

• Helps coordinate the successful completion of documents with other groups

• As needed/appropriate, collaborates with others in the review of safety narratives and other safety-related guidelines and documentation

• Collaborates with clinical operations to develop and implement the overall data quality plan

• Develops and provides input for clinical presentation slides and other materials for internal/external meetings and/or ongoing communications for review/discussion with PD Medical Directors/Clinical Development Physicians (e.g., investigator meetings, pre-study site selection visits, study coordinator or clinical research administrator training,

study newsletters, communications to study sites, etc.)

• Collaborates with clinical operations to develop agendas, materials and other items for investigator and other relevant meetings pertaining to assigned studies and programs

• As needed/appropriate, accompanies clinical operations staff to study site visits, investigator and other meetings

• Provides additional support with site training, as needed, or requested

• Where assigned, acts as the primary CD liaison/point-of-contact from the team for medical monitor inquiries from clinical operations, clinical research organizations (CROs), etc.

• Responds to questions from other internal and external parties regarding assigned studies and programs

• Collaborates with PD Medical Directors/Clinical Development Physicians, clinical operations, data management and other groups to conduct clinical review of study data; identifying and evaluating study data trends, outliers, protocol violators, etc. Works with PD Medical Directors/Clinical Development Physicians, clinical operations, data

management and potentially other groups to develop and communicate relevant medical inquiries

• Participates in safety meetings and tracks, analyzes and reports any potential safety events

• Reviews, analyzes and discusses clinical study reporting documents with PD Medical Directors/Clinical Development Physicians and various other groups

• Tracks items for inclusion in protocol/ICF amendments and works with other groups to ensure the timely and appropriate completion of protocol amendments

• Assists PD Medical Directors/Clinical Development Physicians in responding to HA inquiries

• Supports PD Medical Directors/Clinical Development Physicians in preparing for internal/external meetings and presentations

• Works closely with PD Medical Directors/Clinical Development Physicians, clinical operations and other groups to close-out clinical studies, secure data and complete study reporting

• Participates in the development and implementation of communications strategies to support existing and concluded studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials

• May also deliver key presentations, both internally and externally, to convey the CD perspective and provide updates on strategies, plans and other activities. Includes presenting at advisory boards and other relevant external forums representing Roche

• Writes and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinates further reviews with internal partners and stakeholders.

• Coordinates submissions to scientific meetings and/or other appropriate venues or groups

• Supports PD Medical Directors/Clinical Development Physicians, regulatory and other internal partners/stakeholders with completion and submission of regulatory filings and other regulatory documentation.

• Writes clinical science sections of HA meeting packages and assists in the development and review of other clinical documentation required for regulatory submissions and other regulatory processes

• Works with PD Medical Directors/Clinical Development Physicians to drive ongoing data generation to address unmet medical needs and identify new or extended CD studies or other programs for the relevant therapeutic area of assignment

• Completes and/or leads other special projects, as and when assigned, or otherwise requested

• Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures (SOPs) and other guidelines



QUALIFICATIONS & EXPERIENCE:

• Bachelor’s Degree required (life sciences preferred)

• Advanced Clinical/Science Degree is preferred (e.g., PharmD, PhD, MSN, MPH, etc.)

• 8 or more years clinical trial experience (must demonstrate a minimum of 4 years clinical trial experience in pharma/biotech industry)

• Data listing review experience

• Experience working on a clinical team (or equivalent)

• Experience authoring aspects of a global clinical development plan or full clinical study protocol

• Experience publishing results of a clinical drug trial in a referred journal

• Strong relevant therapeutic area experience (typically demonstrable with 2 or more years relevant experience)

• Has extensive knowledge of clinical research and has successfully worked across Phase II – III drug development projects

• Broad experience in the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)

• Comprehensive understanding of product and safety profiles

• Well-versed in medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations

• Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel)

• Previous people management experience is a plus

ABILITIES:

• Has impeccable ethics. Demonstrates, or proven abilities to demonstrate, Roche Values

• Outstanding attention-to-detail

• Proven abilities to perform Clinical Scientist responsibilities independently and with limited guidance. Has demonstrated, through past experience, abilities to competently manage the majority of Clinical Scientist deliverables associated with assigned clinical studies

• Strong business acumen; has in-depth knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g., clinical operations, biostatistics, regulatory, commercial operations, etc. and can proactively integrate multiple perspectives into the

clinical development process for best end-results

• Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment of such

• Strong interpersonal, verbal communication and influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally

• Outstanding written communication skills

• Strong business presentation skills: highly effective at summarizing and presenting the key considerations and decision-points

• Confident and competent when interacting with varying levels of internal/external management, KOLs, etc.: stays focused and on- point, and is able to raise problems or challenges in a productive and mature manner

• Strong negotiation skills: can effectively drive discussions and decisions toward desired end results

• Proven track record of effective decision-making: makes good business decisions and exercises sound judgment. Consistently and effectively balances decisions with imperatives for ethics and efficacy

• Proven teamwork skills: has a proven track record of working highly effectively, efficiently and collaboratively with others. Has proven experience and skills working with multidisciplinary teams

• Strong financial acumen: proven abilities for effective planning, development and oversight of project budgets and other resources

• Aptitude or proven ability to manage others (can lead and motivate direct reports, as well as prioritize and oversee their work through to

successful outcomes)

• Ability to travel (<30%)

2/14/20 Clinical Scientist - Product Development Oncology (Entrectinib/TAPISTRY) Individual contributor South San Francisco, California

Roche’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase II – IIIA) clinical strategies and plans to deliver medically-differentiated therapies that provide meaningful improvement to patients. The PD Clinical Scientist participates in development of the Clinical Development (CD) strategy and plan and supports the assigned PD Medical Director/Clinical Development Physician(s) with various deliverables necessary for effective and efficient CD plan execution for the assigned molecule(s)/indication(s). PD Clinical Scientists have primary responsibilities for supporting PD Medical Directors/Clinical Development Physicians with clinical documentation, representing CD on various sub-teams or other appropriate forums, supporting training of study site personnel, acting as a primary point-of-contact for questions and inquiries to CD regarding CD studies or other programs, conducting ongoing medical/safety data reviews, and providing clinical science inputs into study reporting. PD Clinical Scientists are expected to perform their responsibilities independently. PD Clinical Scientists are likely to have regular external interactions with cooperative groups, key opinion leaders (KOLs), external vendors supporting the work of CD, etc. They may also, alongside the PD Medical Director/Clinical Development Physician, participate in external interactions with health authorities (HAs).

PRIMARY DUTIES AND RESPONSIBILITIES:



1. Cross-Functional Team Leadership & Management

• Participates in the relevant Clinical Science Team (CST)

• Represents CD in sub-teams (e.g., Study Management Teams) relevant to assigned molecule(s)/indication(s), except the Development Team (DT). As needed and appropriate, addresses CD study or other program-specific questions; provides updates; delivers presentations; etc. May act as the lead CD representative on sub-teams

• As requested, or otherwise appropriate, trains new CST members

• May also, as appropriate, support relevant sub-teams in assigning and training new team members

• As appropriate, participates in ongoing enhancements/development of team processes, structures, systems, tools and other resources

• As appropriate, coaches and guides less experienced Clinical Scientists

• Where applicable, may manage one or more direct reports and is, in such instances, responsible for hiring, training, developing and retaining talent on his/her staff. Consistently complies with all governing employment laws, regulations and company HR policies & procedures

2. Global Clinical Development Planning

• Stays abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s)

• As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects

• Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment

• Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and KOLs, as well as multidisciplinary internal groups, including other groups in PD, research, business development, commercial operations, legal, etc.

• May participate in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to provide clinical science input and guidance. Includes reviewing Phase I protocols and providing CD input into these

• Supports internal partners in transitioning new drugs/indications into Phase IIIB or publication studies. May review Phase IIIB protocols and other information and provide CD input into these

• Expected to make important contributions to the CD strategy for the relevant therapeutic/disease area(s)

• Participates, alongside PD Medical Directors/Clinical Development Physicians, in the development of clinical science contributions into annual and strategic Lifecycle Plans (LCPs) and the Integrated Development Commercialization Plan (IDCP)

• Develops the CD plan with the PD Medical Director/Clinical Development Physician for assigned molecule(s)/indication(s) and/or other programs Gathers and analyzes data and information necessary to create the CD plan. May also delegate such research and analysis to less experienced Clinical Scientists

• Supports PD Medical Directors/Clinical Development Physicians by providing additional guidance and direction to CSTs and other relevant teams in developing all CD plan components (e.g. analytics/data strategy, KOL development, publications strategy, etc.)

• Where applicable and assigned, supports PD Medical Directors/Clinical Development Physicians in providing other groups with information and input into budget/resource requirements necessary to implement and execute the CD plan

• Supports PD Medical Directors/Clinical Development Physicians in preparing for HA meetings. As appropriate, participates in HA meetings. Ethically, effectively and professionally represents the interests of Roche and patients

3. Clinical Development Plan Implementation

• Provides strategic clinical science support for assigned studies and programs:

• Leads or otherwise participates in ongoing CST and relevant sub-team meetings, other interactions and communications

• Develops innovative clinical study designs for review and discussion with PD Medical Directors/Clinical Development Physicians and/or Global Development Leaders (GDLs)

• Conducts appropriate literature searches

• Collaborates with clinical operations, other groups and PD Medical Directors/Clinical Development Physicians to develop consistent language and criteria for the Informed Consent Form (ICF), protocol eligibility, protocol dose modification, protocol safety, Case Report Forms (CRFs), CRF instructions, etc. Helps coordinate consistent use of language and criteria across multiple Roche teams and projects (includes partner studies)

• Reviews and/or writes additional clinical science documentation and/or clinical science input into other documentation managed by other Roche groups (e.g., protocol summaries, safety monitoring plans, process documents, investigator brochures, etc.)

• Helps coordinate the successful completion of documents with other groups

• As needed/appropriate, collaborates with others in the review of safety narratives and other safety-related guidelines and documentation

• Collaborates with clinical operations to develop and implement the overall data quality plan

• Develops and provides input for clinical presentation slides and other materials for internal/external meetings and/or ongoing communications for review/discussion with PD Medical Directors/Clinical Development Physicians (e.g., investigator meetings, pre-study site selection visits, study coordinator or clinical research administrator training,

study newsletters, communications to study sites, etc.)

• Collaborates with clinical operations to develop agendas, materials and other items for investigator and other relevant meetings pertaining to assigned studies and programs

• As needed/appropriate, accompanies clinical operations staff to study site visits, investigator and other meetings

• Provides additional support with site training, as needed, or requested

• Where assigned, acts as the primary CD liaison/point-of-contact from the team for medical monitor inquiries from clinical operations, clinical research organizations (CROs), etc.

• Responds to questions from other internal and external parties regarding assigned studies and programs

• Collaborates with PD Medical Directors/Clinical Development Physicians, clinical operations, data management and other groups to conduct clinical review of study data; identifying and evaluating study data trends, outliers, protocol violators, etc. Works with PD Medical Directors/Clinical Development Physicians, clinical operations, data

management and potentially other groups to develop and communicate relevant medical inquiries

• Participates in safety meetings and tracks, analyzes and reports any potential safety events

• Reviews, analyzes and discusses clinical study reporting documents with PD Medical Directors/Clinical Development Physicians and various other groups

• Tracks items for inclusion in protocol/ICF amendments and works with other groups to ensure the timely and appropriate completion of protocol amendments

• Assists PD Medical Directors/Clinical Development Physicians in responding to HA inquiries

• Supports PD Medical Directors/Clinical Development Physicians in preparing for internal/external meetings and presentations

• Works closely with PD Medical Directors/Clinical Development Physicians, clinical operations and other groups to close-out clinical studies, secure data and complete study reporting

• Participates in the development and implementation of communications strategies to support existing and concluded studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials

• May also deliver key presentations, both internally and externally, to convey the CD perspective and provide updates on strategies, plans and other activities. Includes presenting at advisory boards and other relevant external forums representing Roche

• Writes and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinates further reviews with internal partners and stakeholders.

• Coordinates submissions to scientific meetings and/or other appropriate venues or groups

• Supports PD Medical Directors/Clinical Development Physicians, regulatory and other internal partners/stakeholders with completion and submission of regulatory filings and other regulatory documentation.

• Writes clinical science sections of HA meeting packages and assists in the development and review of other clinical documentation required for regulatory submissions and other regulatory processes

• Works with PD Medical Directors/Clinical Development Physicians to drive ongoing data generation to address unmet medical needs and identify new or extended CD studies or other programs for the relevant therapeutic area of assignment

• Completes and/or leads other special projects, as and when assigned, or otherwise requested

• Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures (SOPs) and other guidelines



QUALIFICATIONS & EXPERIENCE:

• Bachelor’s Degree required (life sciences preferred)

• Advanced Clinical/Science Degree is preferred (e.g., PharmD, PhD, MSN, MPH, etc.)

• 8 or more years clinical trial experience (must demonstrate a minimum of 4 years clinical trial experience in pharma/biotech industry)

• Data listing review experience

• Experience working on a clinical team (or equivalent)

• Experience authoring aspects of a global clinical development plan or full clinical study protocol

• Experience publishing results of a clinical drug trial in a referred journal

• Strong relevant therapeutic area experience (typically demonstrable with 2 or more years relevant experience)

• Has extensive knowledge of clinical research and has successfully worked across Phase II – III drug development projects

• Broad experience in the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)

• Comprehensive understanding of product and safety profiles

• Well-versed in medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations

• Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel)

• Previous people management experience is a plus

ABILITIES:

• Has impeccable ethics. Demonstrates, or proven abilities to demonstrate, Roche Values

• Outstanding attention-to-detail

• Proven abilities to perform Clinical Scientist responsibilities independently and with limited guidance. Has demonstrated, through past experience, abilities to competently manage the majority of Clinical Scientist deliverables associated with assigned clinical studies

• Strong business acumen; has in-depth knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g., clinical operations, biostatistics, regulatory, commercial operations, etc. and can proactively integrate multiple perspectives into the

clinical development process for best end-results

• Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment of such

• Strong interpersonal, verbal communication and influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally

• Outstanding written communication skills

• Strong business presentation skills: highly effective at summarizing and presenting the key considerations and decision-points

• Confident and competent when interacting with varying levels of internal/external management, KOLs, etc.: stays focused and on- point, and is able to raise problems or challenges in a productive and mature manner

• Strong negotiation skills: can effectively drive discussions and decisions toward desired end results

• Proven track record of effective decision-making: makes good business decisions and exercises sound judgment. Consistently and effectively balances decisions with imperatives for ethics and efficacy

• Proven teamwork skills: has a proven track record of working highly effectively, efficiently and collaboratively with others. Has proven experience and skills working with multidisciplinary teams

• Strong financial acumen: proven abilities for effective planning, development and oversight of project budgets and other resources

• Aptitude or proven ability to manage others (can lead and motivate direct reports, as well as prioritize and oversee their work through to

successful outcomes)

• Ability to travel (<30%)

2/14/20 Associate Group Director, Process Strategy South San Francisco, California

Who We Are

At Roche, 88,500 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

This Associate Group Director, Process Strategy position is in Scientific Enablement & Processes, which sits in Pharmacovigilance & Scientific Enablement (PVSD), part of Product Development Safety Risk Management (PDS).  PVSD is a diverse function that collaborates across PDS, the wider company and externally, to drive, enable and coordinate new innovation, continuous improvement and a variety of core business services that support PDS, the wider Roche Safety community and the PV System. 

The Position

The Associate Group Director, Process Strategy is an exciting opportunity to take on a critical role to be a strategic line-leader, responsible for the development of a cohesive strategy across key areas affecting the design, prediction, and decision making support for our safety programs to the downstream needs of our stakeholders in communicating & managing patient risk.  This strategic line-leader will translate this strategy by managing and driving the key deliverables of their own Processes team within the SEP organization. Responsibilities include:

  • To support the Global Head of SEP in the formulation and execution of the organizational strategy, design, development, implementation and coordination of activities relating to process design, continuous improvement of the critical PV processes, and enable process implementation & deployment of new and/or augmented safety capabilities within their assigned domain of the Safety value chain (e.g Safety program design, profile prediction, to communication & managing patient risk).  

  • To ensure that the critical Pharmacovigilance processes and processes for new safety capabilities are cohesively designed, developed, ‘owned’ by a global process owner and supported in line with business requirements and continuous improvement principles from within their team. They are also expected to serve as a Global/Business process owner of one or more critical PV processes as required by business need. 

  • Lead their teams to preemptively explore strategic opportunities to enable the implementation of new safety capabilities whether through process development, improvement, etc. 

  • Influence the ongoing evolution of the Roche safety strategy through the perspective of global process needs (GVP/GCP) and leading their teams to improve their respective global processes leveraging the benefits of the Roche safety strategy.

  • To influence and communicate effectively with wider business stakeholders, (including at senior leadership levels), to drive cross-functional process improvements and obtain broad organizational alignment.  

  • Line-leadership of all levels of seniority of PV Process Leaders and Scientists within SEP globally; provide strategic direction, mentoring, and professional development for their team members and contributes to the ongoing development of SEP as a whole.

Who you are

  • Degree in a medical or healthcare-related discipline (e.g. MD, PharmD, dentistry), combined with clinical experience. Or a higher degree (e.g. PhD) in a life sciences discipline of relevance to clinical development, drug safety or regulatory affairs. 

  • Relevant experience in pharmacovigilance, safety or clinical science, and/or other relevant areas of clinical biopharmaceutical development or medical affairs (typically 10+ years of experience).

  • A higher qualification in a relevant scientific or business discipline (e.g. pharmacovigilance, epidemiology, MBA, pharmaceutical medicine, etc.) is desirable.

  • Excellent leadership skills, with the proven ability to lead global line- or matrix- teams in accordance with the Roche leadership commitments and values. Preferably with experience of working across diverse geographic areas, business settings and cultures.

  • An in-depth understanding of biopharmaceutical drug development and commercialization, including the ability to anticipate where activities may need to be prioritized in order to make significant improvements in existing business performance, or where the business can exploit future opportunities.

  • Proven experience of applying business process improvement methodologies and/or developing ideas into practical business solutions. Prior experience in managing complex programs of high business importance/risk is desirable.

  • Highly developed influencing skills, with the proven ability to establish effective collaborations across business units and to influence decisions without authority.

  • The ability shape external thinking and/or policies (e.g. involvement in external industry working groups; ability to influence stakeholder decisions).

  • Experience of delivering or managing scientific and/or pharmacovigilance activities/processes that represent current or future deliverables for PDS.

  • In-depth knowledge of regulatory pharmacovigilance requirements and guidelines published by the major global Health Authorities.

  • An understanding of pharmacoepidemiology and its application to clinical safety related activities in product development and post-marketing.

  • Advanced strategic and analytical thinking skills, with the ability to rapidly assimilate complex information to inform decisions, and/or make effective business proposals in situations of ambiguity.

  • Excellent written and verbal communication skills and the ability to present and critically discuss clinical data and compliance-related process issues.

Travel Requirements:  

  • International business travel up to 15% of the time may be required, depending upon the business location of the jobholder and ongoing business project activities.

2/14/20 Senior Safety Scientist South San Francisco, California

Senior Safety Scientist

Job Purpose: Portfolio Safety Scientists (PCS-Sci) provide safety science and pharmacovigilance support to molecules across the Roche portfolio. As a group, they are responsible for all aspects of safety science/pharmacovigilance, with accountability being held by PCS leadership and experts or SSLs (Safety Strategy Program Leaders) depending on the deliverable/activity.

The Portfolio Safety Scientists (PCS-Sci) supports early and late phase development activities as a member of the safety team, providing essential safety oversight and input into all aspects of study management across the entire development and marketed portfolio. In the post-market setting this may include and may include signal evaluation, safety related activities associated with new drug applications/regulatory filings, benefit-risk assessment and safety risk management. A Senior Safety Scientist will be supported by supervision from one or more experienced colleagues but is expected to be able to work unsupervised on less complex deliverables. They will be expected to continue learning about Safety Science/Pharmacovigilance and the broader aspects of drug development.

Job Responsibilities:

Under the matrix leadership of the SSL and/or in collaboration with PCS colleagues

  • Develop and maintain an understanding of the safety profile of their assigned product(s) or therapy areas
  • Responsible for individual and aggregate case reporting activities including ICSR case management (medical review) and aggregate reporting (i.e. DSUR, PBRER)
  • Responsible for signal detection and management activities including, but not limited to STAR maintenance, ISMP maintenance. Contribute to the strategy and review of safety assessments and drug safety reports for signals or issues (inc, product quality) or in response to Regulatory Authority requests
  • Contributing to risk management activities including preparation and maintenance of CCDS, labeling document maintenance, risk communications, RMP, REMS
  • Contributing to study management from a safety perspective through SMT/PET and document review and maintenance across the development continuum (early phase to post marketing studies), including PASS
  • Acts independently to manage safety responsibilities on study teams and in activities supporting safety science
  • Contribute to regulatory authority submissions (Investigational New Drug/IND applications, New Drug Applications/NDAs, Marketing Authorization Applications/MAAs, Variations, Renewals, etc.) by reviewing safety data and preparing relevant sections of the filing and submission packages in consultation with SSL and PSS Team Lead
  • Participate in and provide input for Drug Monitoring Committees (iDMC) or internal monitoring committee (IMC) meetings, as applicable
  • Responsible for coordination and collaboration with vendors servicing Safety Science
  • Take on the responsibility for appropriate specialised roles with PCS. These may include, but are not limited to; functional business process owner, subject matter expert.

Behaviours and responsibilities

  • Demonstrates behaviors consistent with Roche values and engenders confidence from senior management
  • Actively emulate and role model the Roche values, culture (mindset and behavior), Roche core competencies and PD/PDS strategy and drive for similar performance across relevant team
  • Understands how safety activities contribute to company development and commericalisation goals and takes measures to maximize safety value to the organization
  • Demonstrates independence and high competence in the conduct of all safety science responsibilities
  • Ensures all actions are conducted in alignment with Roche quality management systems
  • Develop and maintain knowledge of the pharmaceutical industry and drug development, including a comprehensive knowledge of pharmacovigilance activities and requirements
  • Trains and mentors more junior members of the safety team
  • Takes on responsibility for more complex deliverables
  • Takes on leadership responsibility in order to manage and complete low to medium priority projects
  • Establish and maintain collaborative working relationships with all key stakeholders, and internal and external customers and ensure the same across relevant teams
  • Consistently comply with all governing laws, regulations, Roche standard operating procedures (SOPs) and other guidelines
  • Willing to challenge embedded behaviors/mindsets, in order to bring new and agile approaches to ways of working, and/or to improve quality and efficiency.
  • Holds themselves and peers accountable for their behaviours and actions.

Education, Skills and Experience

Minimum Qualifications: Qualified healthcare professional or Life Sciences graduate.

Preferred Qualifications: A relevant postgraduate qualification (e.g. PHD/MSc in a Life sciences discipline; Medical qualification; PharmD or other post-graduate health professional qualifications) would be advantageous

Safety scientist (level 2): 2 or more years of drug safety, clinical development or medical affairs experience in the pharmaceutical or related industry

  • Understanding of GxP and regulated processes and end to end clinical trial lifecycle
  • Strong orientation towards process improvement and cross-functional teamwork
  • Effectively work with remote partners on a global team
  • Excellent communication skills, both written and verbal
  • Perform data analysis / statistical methods to evaluate, interpret and present scientific data with clarity
  • Good presentation skills, effective at summarizing and presenting the key considerations and decision points
  • Ability to train others on departmental practices and processes
  • Understanding of project management methodology

#LI-PDAB1

2/14/20 Program Manager, Regulatory Program Management Individual contributor South San Francisco, California

GENERAL POSITION SUMMARY/PURPOSE:

Regulatory Program Management is part of the broader PDR organization that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for Roche’s global Pharma Medicines Division, which includes all therapeutic areas and all phases of product development from early development to post-marketing. PDR is responsible for the timely submission of applications to health authorities for approval of new products and line extensions. PDR is committed to regulatory strategies that are the most innovative, ethical, and influential in the industry. Like others in Regulatory Program Management, Program Managers are assigned their responsibilities by therapeutic area, and are assigned projects for different product development phases, as business needs dictate. Regulatory Program Management Program Managers support regulatory program management for one or more development projects. Regulatory Program Management Program Managers participate in and support the development and implementation of regulatory strategies to facilitate the development and approval of Roche medicines for human use. Program Managers are expected to perform their responsibilities with supervision. Regulatory Program Management Program Managers work cross-functionally and help coordinate regulatory-related activities across PDR functions and with other internal partners. 

JOB DESCRIPTION – PRIMARY DUTIES AND RESPONSIBILITIES:

Intact & Cross-Functional Teams

  • Participates in site and/or regional and/or global PDR Program Management departmental meetings
  • Participates as a standing member in the Regulatory Affairs Functional Team (RAFT) for assigned product development projects to help ensure effective and efficient cross-functional PDR coordination, appropriate resources, and timely, thorough and compliant execution
  • As assigned or otherwise needed, assists relevant Regulatory Program Management Program Directors with their interactions, communications and planning with various other teams, dependent upon assigned projects and the associated development phase, such as early development core teams, global development teams and lifecycle teams. Helps Regulatory Program Management Program Directors coordinate cross-functional PDR contributions to product development projects and other related activities
  • As assigned, may act as a standing or ad hoc member of other teams for special or ongoing initiatives and projects

Regulatory Program Management

  • Stays abreast of internal and external developments, trends and other dynamics relevant to the work of PD and PDR to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for assigned therapeutic areas and projects. Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics.  Briefs teams and management, as appropriate
  • Obtains and applies in-depth knowledge of Roche and regulatory guidelines, procedures and best practices
  • Stays abreast of therapeutic area product development and other related business strategies and plans  
  • Supports on one or more regional projects at any one point in time
  • Analyzes data, the regulatory environment and business objectives to advise others on applicability of new or existing regulations and guidelines
  • Participates in the development and implementation of the cross-functional regulatory strategy for each project or related assignment
  • Supports Regulatory Program Management Program Directors in identifying and aligning cross-functional regulatory resources necessary to execute the regulatory strategy for each project or related assignment

Other

  • Participates in and/or otherwise supports development and implementation of new or updated PDR and/or Regulatory Program Management-specific systems, processes, Standard/Department Operating Procedures (SOPs/DOPs) or other relevant tools  
  • Completes other routine and ad hoc analysis and reporting. Responsible to keep all internal customers, partners and stakeholders abreast of progress and interim updates. Does so by following prescribed departmental procedures, practices and protocols and by using standardized reporting and communications tools/templates and other resources
  • Participates in other special projects, as and when assigned, or otherwise requested  
  • Participates in routine and ad hoc departmental meetings and other business reviews or meetings to remain, at all times, fully abreast and apprised of evolving internal and external needs and requirements. Expected to share best practices within the department and cross-functionally, identify and communicate opportunities for departmental enhancements and efficiencies
  • Consistently complies with all governing laws, regulations, Roche SOPs and other guidelines
  • Supports Regulatory Program Management Program Directors and others in preparing and facilitating meetings, teleconferences and other interactions/communications with regulatory authorities.  Establishes effective working relationships internally and externally with regulatory authorities
  • Documents meetings, teleconferences and other interactions/communications with regulatory authorities
  • Supports Regulatory Program Management Program Directors in providing internal teams with direction on regulatory authority interactions
  • Participates in and supports management of ongoing RAFT meetings. Including providing ongoing guidance on regulatory deliverables, compliance, timing and other relevant matters.  Helps manage RAFT resources, including documenting meeting minutes and conducting follow-up to ensure action items are completed in a timely and thorough manner
  • Helps manage project plans and timelines for assigned projects
  • As assigned, performs literature searches, prepares special reports and assembles documentation to support project teams
  • Supports Regulatory Program Management Program Directors with a first-line of internal approvals for regulatory submissions and other relevant regulatory documentation. Helps ensure that all elements, quality, accuracy and format of regulatory submissions and other documentation comply with applicable laws, regulations and Roche standards
  • Supports effective, best-practice maintenance of various clinical and non-clinical regulatory documents
  • Helps Regulatory Program Management Program Directors manage all PDR deliverables associated with each project or other assignment to ensure these are completed within defined timelines and meet regulatory and other company guidelines
  • Participates in and supports development of regulatory risk management and contingency plans. Develops associated communication plans for Regulatory Program Management  Program Directors and their internal distribution   
  • Supports management of relevant project budgets to ensure compliance with agreed parameters and provides routine and ad hoc budget reporting and other updates
  • As requested or otherwise appropriate, supports Regulatory Program Management Program Directors in providing regulatory due diligence assessments in cooperation with other internal groups

QUALIFICATIONS & EXPERIENCE:

  • Bachelors Degree required (life sciences disciplines strongly preferred)
  • Advanced Degree in related field is preferred
  • Average of 3 or more years’ relevant experience in regulatory affairs or related functions in drug/biologics development/manufacturing
  • Demonstrated understanding of international regulations, processes and issues in drug/biologics development. Includes sound knowledge of GxP (Good Practices for quality guidelines and practices in the pharmaceutical/biotechnology or related industry), GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines
  • Demonstrated experience working with the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)
  • Demonstrated understanding of product and safety profiles
  • Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat
  • Fluent English and other language skills as needed

ABILITIES:

  • Has impeccable ethics.  Demonstrates, or has proven abilities to demonstrate, Roche Values & Leadership Competencies
  • Outstanding attention-to-detail
  • Has working knowledge of the multidisciplinary functions involved in pharmaceutical/biotechnology product development, e.g., clinical development, clinical operations, biostatistics, commercial operations, etc.
  • Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment of such
  • Good interpersonal, verbal communication and influencing skills: can influence without authority
  • Strong written communication skills
  • Good business presentation skills: is comfortable and effective when presenting to others, internally and externally  
  • Good negotiation skills: knows how to complete deliverables by working effectively with others internally and externally
  • Good judgment and decision-making skills: knows how to make trade-off decisions while balancing ethics and efficacy
  • Works well within teams and is effective in collaborating with others internally and externally
  • Ability to travel (<10%)
2/14/20 Associate Regulatory Program Manager Individual contributor South San Francisco, California

GENERAL POSITION SUMMARY/PURPOSE:

Regulatory Program Management is part of the broader PDR organization that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for Roche’s global Pharma Medicines Division, which includes all therapeutic areas and all phases of product development from early development to post-marketing. PDR is responsible for the timely submission of applications to health authorities for approval of new products and line extensions. PDR is committed to regulatory strategies that are the most innovative, ethical, and influential in the industry. Like others in Regulatory Program Management, Associate Program Managers are assigned their responsibilities by therapeutic area, and are assigned projects for different product development phases, as business needs dictate. Regulatory Program Management Associate Program Managers support regulatory program management for one or more development projects. Regulatory Program Management Associate Program Managers participate in and support the development and implementation of regulatory strategies to facilitate the development and approval of Roche medicines for human use. This position is considered entry-level for Regulatory Program Management and, as such, Associate Program Managers are expected to perform their responsibilities with considerable supervision. Regulatory Program Management Associate Program Managers work cross-functionally and help coordinate regulatory-related activities across PDR functions and with other internal partners. 

JOB DESCRIPTION – PRIMARY DUTIES AND RESPONSIBILITIES:

Intact & Cross-Functional Teams

  • Participates in site, regional and/or global PDR Program Management departmental meetings
  • Participates as a standing member in the Regulatory Affairs Functional Team (RAFT) for assigned product development projects to help ensure effective and efficient cross-functional PDR coordination, appropriate resources, and timely, thorough and compliant execution
  • As assigned or otherwise needed, assists relevant Regulatory Program Directors with their interactions, communications and planning with various other teams, dependent upon assigned projects and the associated development phase, such as early development core teams, global development teams and lifecycle teams. Helps Regulatory Program Directors coordinate cross-functional PDR contributions to product development projects and other related activities
  • As assigned, may act as a standing or ad hoc member of other teams for special or ongoing initiatives and projects

Regulatory Program Management

  • Stays abreast of internal and external developments, trends and other dynamics relevant to the work of PD and PDR to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for assigned therapeutic areas and projects. Expected to develop and maintain his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics.  Briefs teams and management, as appropriate
  • Obtains and applies in-depth knowledge of Roche and regulatory guidelines, procedures and best practices
  • Stays abreast of therapeutic area product development and other related business strategies and plans  
  • Supports on one or more regional projects at any one point in time
  • Participates in the development and implementation of the cross-functional regulatory strategy for each project or related assignment
  • Supports Regulatory Program Directors in identifying and aligning cross-functional regulatory resources necessary to execute the regulatory strategy for each project or related assignment
  • Supports Regulatory Program Directors and others in scheduling and preparing for meetings, teleconferences and other interactions/communications with regulatory authorities. Establishes effective working relationships internally and externally with regulatory authorities
  • Documents meetings, teleconferences and other interactions/communications with regulatory authorities
  • Supports Regulatory Program Management Program Directors in providing internal teams with direction on regulatory authority interactions
  • Participates in and supports management of ongoing RAFT meetings. Including providing ongoing guidance on regulatory deliverables, compliance, timing and other relevant matters. Helps manage RAFT resources, including documenting meeting minutes and conducting follow-up to ensure action items are completed in a timely and thorough manner
  • Helps manage project plans and timelines for assigned projects
  • As assigned, performs literature searches, prepares special reports and assembles documentation to support project teams
  • Supports Regulatory Program Management Program Directors with a first-line of internal approvals for regulatory submissions and other relevant regulatory documentation. Helps ensure that all elements, quality, accuracy and format of regulatory submissions and other documentation comply with applicable laws, regulations and Roche standards
  • Supports effective, best-practice maintenance of various clinical and non-clinical regulatory documents
  • Helps Regulatory Program Management Program Directors manage all PDR deliverables associated with each project or other assignment to ensure these are completed within defined timelines and meet regulatory and other company guidelines
  • Participates in and supports development of regulatory risk management and contingency plans. Develops associated communication plans for Regulatory Program Management Program Directors and their internal distribution   
  • Supports management of relevant project budgets to ensure compliance with agreed parameters and provides routine and ad hoc budget reporting and other updates
  • As requested or otherwise appropriate, supports Regulatory Program Management Program Directors in providing regulatory due diligence assessments in cooperation with other internal groups

Other

  • Participates in and/or otherwise supports development and implementation of new or updated PDR and/or Regulatory Program Management-specific systems, processes, Standard/Department Operating Procedures (SOPs/DOPs) or other relevant tools  
  • Completes other routine and ad hoc analysis and reporting. Responsible to keep all internal customers, partners and stakeholders abreast of progress and interim updates. Does so by following prescribed departmental procedures, practices and protocols and by using standardized reporting and communications tools/templates and other resources
  • May participate in other special projects, as and when assigned, or otherwise requested  
  • Participates in routine and ad hoc departmental meetings and other business reviews or meetings to remain, at all times, fully abreast and apprised of evolving internal and external needs and requirements. Expected to share best practices within the department and cross-functionally, identify and communicate opportunities for departmental enhancements and efficiencies
  • Consistently complies with all governing laws, regulations, Roche SOPs and other guidelines

SELECTION CRITERIA:

Candidates for this position should hold the following qualifications, have the following experience, and be able to demonstrate the following abilities to be considered as a suitable applicant. Please note that except where specified as “preferred,” or as a “plus,” all points listed below are considered minimum requirements.

QUALIFICATIONS & EXPERIENCE:

  • Bachelors Degree required (life sciences disciplines strongly preferred)
  • Advanced Degree in related field is preferred
  • Some relevant experience in regulatory affairs or related functions in drug/biologics development/manufacturing is strongly preferred
  • Knowledge of, or aptitude to learn, international regulations, processes and issues in drug/biologics development. Includes GxP (Good Practices for quality guidelines and practices in the pharmaceutical/biotechnology or related industry), GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines
  • Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat
  • Fluent English and other language skills as needed

ABILITIES:

  • Has impeccable ethics.  Demonstrates, or has proven abilities to demonstrate, Roche Values & Leadership Competencies
  • Strong attention-to-detail
  • Has some grounding and understanding of the multidisciplinary functions involved in pharmaceutical/biotechnology product development
  • Strong project management, organization and time management skills: has a track record of consistently meeting or exceeding assigned goals and objectives
  • Good verbal communication, influencing and negotiation skills: works well with and through others
  • Strong written communication skills
  • Good judgment and decision-making skills: knows how to make trade-off decisions while balancing ethics and efficacy
  • Demonstrated orientation to teamwork: has been effective in the past working in cross-functional teams
2/14/20 MSL Field Director, Lytics - National Manager with direct reports California

MSL Field Director Job Description

Position Overview

From the beginning, Genentech has been a team of highly dedicated, passionate individuals. We are a place where people are united around a single purpose and an ambitious vision. Together, we aspire to deliver ever better health outcomes for patients while lowering overall healthcare costs. 

The Therapeutic Area (TA) MSL Field Director is responsible for creating, leading, and inspiring a large regional MSL team, focused on enhancing patient outcomes through improved customer engagement. They will work with TA MSL Head, to support the creation of the long-term vision and strategic / tactical plan for regions and individual ecosystems, in partnership with Senior Leaders across the organization including Squad Medical Partner, Field Medical Partner, Medical Executive Directors (MEDs) and Medical Network (NoS).

The TA MSL Field Director plays a crucial role in facilitating strong MSL relationships across the healthcare landscape with external scientific, medical, and patient communities in their region, and is expected to build relationships with key customers through expert peer-to-peer engagements. By maintaining a high-level understanding of customer needs across their therapeutic area at a regional level, they are expected to understand and evaluate the organization’s opportunities and constraints to advance the care continuum and the delivery of healthcare through broad clinical and population health research opportunities and build capabilities with an enterprise mindset.

The TA MSL Field Director will provide medical leadership and work with their TA MSL team to ensure national and regional decisions are pulled through at the local level. They are also accountable for coaching, mentoring and leading their TA MSL team to deliver a valued scientific customer experience. They will shape TA MSL competencies, tools and resources that foster scientific exchange with key stakeholders across the healthcare landscape (e.g., local and external scientific and medical communities, managed care, etc.). The TA MSL Field Director is also accountable for ensuring that the TA MSL team stays abreast of the latest innovations in the therapeutic area and shares actionable insights with appropriate stakeholders across the organization.

Key Accountabilities:

Co-create the regional strategy, objectives, and priorities with Squad and MED partners in alignment with business needs, in response to the changing healthcare landscape and customer needs, in order to increase customer satisfaction, improve outcomes and lower overall healthcare costs  Develop strong relationships with regional TAEs in their therapeutic area and be accountable to the relationship building / bridging within Genentech and Roche. Engage, develop and perform Medical Affairs Executive Director (MED) type activities as needed per ecosystem and act as a ‘additional resource’ to the ecosystem MED as needed. Inspire, lead with and without specific authority, and provide strategic professional development, mentorship and coaching so that their team is empowered to deliver all aspects related to scientific exchange Maintain effective and regular two-way communication with Squads, medical team partners, regional field partners, ecosystem teams and MEDs to create a continuous feedback loop of information and insights to interpret and co-create the regional medical strategy and ensure consistency in strategic regional priorities Inspire and lead regional MSL team to ensure operation at full potential, consistent delivery above and beyond for customers, patients, and healthcare stakeholders while leveraging Roche/ Genentech capabilities (inclusive of our medicines, services, technology, talents); strong work ethic, pushing self and team to go above and beyond in looking for opportunities to enhance the customer experience Work closely with TA MSL Head, TA MSL and MED Field Directors to align regional medical strategies and priorities and ensure pull through across ecosystems. Identify resources and tools needed to empower MSLs to deliver all aspects related to scientific exchange on clinical and HEOR data across the entire healthcare landscape Build, cultivate and leverage relationships with key customers to deliver on their needs and ensure strong understanding of evolving healthcare trends; stay updated on relevant therapeutic area and business topics to drive innovation and cross-pollination within team and across the organization

Key Activities & Responsibilities: 

  • Co-create, with TA MSL Head, TA MSL, MED Field Directors, Squad partners and medical network partners, customer-specific strategy, vision, objectives, and priorities based on squad priorities and national medical strategy
  • Build, cultivate and leverage relationships with external regional scientific, medical, and managed care communities to ensure strong understanding of evolving healthcare trends
  • Serve in MED role with specific customers in the region, drawing on high level knowledge of Genentech portfolio, healthcare landscape, and specific customer needs
  • Attend conferences each year to stay up-to-date on the latest scientific developments and network with thought leaders, TAEs, and other key customers (ie specific to their regional TAE assignments – leverage through conferences).
  • Attend and contribute to regional Field Director meetings and Squad meetings as needed in therapeutic area to discuss and raise relevant regional issues to FMT Head and internal stakeholders, requiring enterprise mindset and strong business understanding of customer needs and priorities within their region
  • Collaborate across CMG regional Field Directors to understand regional needs from a broader perspective, ensure consistency in strategic priorities and co-create and deliver customer-centric solutions 
  • Act as player / coach for TA MSLs to support key deliverables that focus on issues specific to customer need from scientific exchange, clinical trials, managed care topics, value-based topics and customer engagement across USMA, disease specific medical teams, and the broader Genentech organization
  • Work with TA MSL Head, TA MSLs to identify upskilling opportunities and ensure TA MSLs are upskilled on topics relevant to customers (e.g., medical, scientific, value-based / total cost care discussions, and customer experience) with CMG T&D
  • Accompany TA MSLs on 2-3 field rides per month to coach TA MSLs in field (typically ~70% of the time in field); work within the ecosystem and region to enable ecosystem specific initiatives to implement in a timely fashion.
  • Is proficient in TA MSL role and can step in for open roles / leave of absences (will likely require a field proficiency at Field Director level).
  • Maintain the highest standards and levels of scientific, clinical, health economic and technical expertise, and ensure the same among staff members; reviewing and keeping updated on scientific/medical journals and other relevant publications, attending scientific, clinical, commercial and other key conferences, forums, and meetings

Qualifications: 

  • Advanced Clinical/Science Degree required (e.g., PharmD, PhD, MSN, MPH, etc.).  BSN with extensive clinical experience may be considered.
  • 7 years of related work experience (clinical, managed care, or industry experience) strongly preferred, with demonstrable evidence of successfully leading and managing MSL or customer facing team to consistently deliver desired results
  • Prior experience as a field medical science liaison is preferred, with evidence of strong customer engagement skills
  • Outstanding healthcare landscape knowledge, therapeutic area expertise and business acumen required; knows the industry, Genentech's business model and value proposition, product and safety profiles, key competitors and other marketplace factors/dynamics
  • Demonstrated experience with strategic planning, prioritizing and management of high-level initiatives and projects to consistently deliver results required
  • Previous experience with leading, coaching, and developing people and/or teams highly preferred
  • Demonstrates strategic and enterprise thinking, with dedication to deliver innovative, customer-centric solutions
  • Strong communication and effective collaboration skills to work across an extremely matrixed stakeholder organization (e.g., ecosystem teams, Squad, NoS partners, E4A partners, Field partners, Global partners, etc.) with proven record of influencing senior leadership without direct authority
  • Ongoing investment in developing self and others to enable others to achieve their potential, deliver ambitious goals or achieve excellence
  • Embraces an agile mindset to develop necessary processes to get things done. Knows how to organize people and activities effectively to achieve impactful outcomes
  • Learning mindset, open to training and becoming an expert across customer types or multiple therapeutic areas; ability to learn other disease or product areas as business needs and product life cycles change
  • Strong financial acumen: capable of driving and managing larger-scale budget responsibilities
  • GCP (Good Clinical Practice) and ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) proficient
  • In-depth knowledge of Phase IV/post-marketing drug development is preferred

CMG Operating Principles

I put the patient first, always. 

I am obsessed with meeting customer needs. 

I act on behalf of the whole company, not just my team. 

I am inclusive.  

I build a culture of trust. 

I have a growth mindset. 

I act with urgency. 

I am accountable. 

I radically simplify and prioritize for impact. 

I follow the science.

I build our reputation. 

Complies with all laws, regulations, policies and procedures that govern the conduct of Genentech activities

This is a field-based position and requires overnight travel to meet with customers, internal stakeholders, and attend relevant conferences as needed. This position requires significant driving of either a company provided or personal vehicle as well as prolonged periods of sitting, both of which are part of the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business.

#LICOMMCG2

2/14/20 Sr Engineer Vacaville, California

This position is for Sr. Automation Engineer reporting into the CCP2 (Cell Culture Plant 2) Process Automation CSE

(Control System Engineering) group within the Manufacturing Sciences and Technology (MSAT) department.

Process Automation CSE group is responsible for maintaining existing MCS that comprises of POMSNet and Experion

PKS system in compliance state as well as implementing new automation solutions. Major milestones of CCP2

Automation road map include upgrading existing Honeywell MCS, design and build new DeltaV based solution and

migration of standalone PLC based systems to SCADA systems.



The Sr. Engineer will provide automation support on capital projects and implement changes/ improvements on automation

systems in bio-pharmaceutical manufacturing operations as part of the Vacaville manufacturing plant. Major areas in

CCP2 plant includes Media preparation, Fermentation, Centrifugation, Column chromatography, Buffer preparation, TFF

operations, and filtration/freeze operations.



The Sr. Engineer will be responsible for working with vendor on design, build, implementation and validation of DeltaV

based automation system. He/she will be part of a team that provides 24/7 technical support for make, asses, and release

activities and capital project execution. The candidate must be a self-starter who can independently drive projects and

day-to-day work tasks to completion according to schedule and must be able to work well with others as a team member

in an informal results oriented environment.



Responsibilities:

The candidate will provide technical leadership and support of the CCP2 Distributed Control System includes but is not

limited to the following:

- Automation design and support to the manufacturing DCS using the following applications as well as providing leadership

in the implementation of automation changes.

- DeltaV, DeltaV Batch and Syncade

- Honeywell MCS system (Experion PKS and Total Plant Batch applications) and POMS is a PLUS

- Troubleshooting of process, equipment, and system malfunctions or failures involving the DCS/MCS system, including

after hours on-call support. Initiate immediate corrective or preventative actions to ensure continued compliant operation

including emergency change records as needed.

- Provide technical assessments and evaluations for discrepancies that occur during manufacturing operations, as well as

provide technical input for investigation and/or developing and implementing corrective action plans.

- Redline automation functional specifications for automation lead review/approval, troubleshoot the DCS/MCS system and

software, prepare automation change record forms and perform off-line and on-line coding and testing.

- Support and lead Automation projects with activities such as detailed design, design review, implementation, testing/

debug, and troubleshooting and project management.

- Work with Manufacturing, Quality, Facilities, and MSAT departments to implement continuous improvement changes as

well as capital projects ranging from product technology transfers, to DCS migrations.

- Clearly communicate across functional departments at various levels to drive efficient issue resolution and change

implementation.

Qualifications:

- B.S. or M.S. in Engineering such as Automation, Chemical, Electrical, or equivalent preferred.

- 8+ years’ work experience as a practicing professional in cGMP biopharmaceutical production. Work experience

specific to automation design, implementation and/or support involving instrumentation and control systems, preferably in

the biopharmaceutical or pharmaceutical

- Strong experience in design, build and installation of Emerson’s DeltaV, DeltaV Batch

- Experience in Syncade MES and OSI PI is a PLUS

- Experience with programming languages and applications such as C, C# Visual Basic and Microsoft SQL Server is a

plus.

- Thorough understanding of Good Manufacturing Practices (GMPs) as they apply to bioprocess manufacturing.

- Thorough understanding of Good Automated Manufacturing Practice (GAMP) as it applies to automation design,

implementation, and testing.

- Experience of working with systems integrator in design and build of the system is a plus.

- Demonstrated training ability, communication skills, and initiative. Strong written and verbal communication,

interpersonal, leadership, and team skills.

- Must be flexible for after-hours call support rotation and floor support of 24/7 operations.

#PTcareers

2/14/20 Applications Specialist Individual contributor Taipei, Taipei City

Main Tasks & Responsibilities :

- Conduct operator training for end users after installation of instruments設備安裝後為最終用戶提供操作培訓

- Solve application / product problems promptly and completely及時完整的解決產品技術問題

- Conduct product technical training for Sales / Engineers/distributors為銷售人員、維修工程師和經銷商提供技術培訓

- Maintain/update products information promptly維護並及時更新產品資料

- Visit client regularly and promote reagent for value-based management定期拜訪客戶,推廣公司試劑提高價值管理

- Pay periodic visits to Key Accounts for getting user feedbacks on our products and services對重點客戶進行定期拜訪,以得到用戶對於產品及服務的回饋

- Work closely with Service Engineer and Sales team in order to support sales effort, including pre-sales promotion

與維修工程師和銷售人員緊密合作以全力支持銷售活動,包括售前產品推廣

- Coordinate instrument installation with Service Engineer and Sales協助維修工程師和銷售人員安裝設備

- Coordinate customer evaluation of products協助客戶進行產品評估工作

- Assist customers in the interpretation of test results協助客戶解釋測試結果 Prepare and complete monthly report 完成並提交月報

- Conduct business in full compliance to Behavior in Business and Behavior in Competition遵循商業行為準則,合法合理開展業務活動 

- Interact with customers to resolve product or service problems by clarifying the customer's inquiry and complaints. 透過澄清客戶的詢問與投訴,與客戶互動以解決產品或服務之問題。

- Reporting and communicating problems with global service center of respective BA to determine the cause of the problem; expediting correction or adjustment; following up to ensure resolution and execution of required corrective actions. 與各BA之全球服務中心匯報及溝通問題,以確認問題原因、加快更正或調整,及後續追蹤以確認必要之糾正措施的決定和執行。

Education :

At least Bachelor Degree in Clinical Diagnostics or Appropriate  Science or Medical discipline

大學以上學歷,醫學檢驗專業或相關專業

Experience :

more than 2 years experience in hospital diagnostics laboratory and / or similar experience in the industry

具有2年以上醫院診斷實驗室工作經驗,或相關的工作經驗

專業知識與技能 Specific Knowledge & Skills :

Presentation skill演講技巧

Analytic skill分析能力

Training skill培訓技巧

Personal Computer knowledge 電腦使用能力

2/14/20 Senior or Government Contracts & Strategy Manager Individual contributor South San Francisco, California

With Government entities being Genentech’s largest customer, the Government Programs (GP) team within Managed Care and Customer Operations (Channel and Contract Management) is responsible for managing the complexities of Government Pricing to enable patient access through the federal drug programs (Medicare, Medicaid, 340B, Veterans Affairs and Department of Defense Federal Supply Schedule & TRICARE).  GP does this by reporting accurate pricing calculations, paying government rebates and providing strategic value to its managed care partners. Collectively, these efforts help Genentech meet evolving business needs and foster a culture of compliance around government programs.

CMG Operating Principles CMG Operating Principles I put the patient first, always; I am obsessed with meeting customer needs; I act on behalf of the whole company, not just my team; I am inclusive; I build a culture of trust; I have a growth mindset; I act with urgency; I am accountable; I radically simplify and prioritize for impact; I follow the science and I build our reputation. 

Government Contracts & Strategy Manager

Reporting directly to the Associate Director of Government Programs, the Government Contracts and Strategy Managers support Government Programs (GP) teams and collaborates with key business partners to deliver deep insights and actionable strategic and tactical recommendations that enable Genentech to rapidly and appropriately adapt to evolving U.S. government payer practices, policies, relevant legislation, regulations, trends and other dynamics, all in compliance with strict accuracy targets, laws, regulations and GP methodology as well as all applicable Genentech policies and guidelines.  This position may participate in and lead various cross-functional teams and projects, assess and recommend solutions and communicate to relevant stakeholders and management.

Senior Government Contracts & Strategy Manager

In addition to the above, fundamental to this position at the E5 level is the ability to expertly lead, manage and influence on complex, innovative and strategic projects, strong decision-making and ability to resolve issues with high compliant and long-term results.

  • Review managed care strategy proposals to identify and resolve (if necessary) implications for government programs reimbursement rates and access, and GP operations (e.g., government price calculations, Medicaid payments)

  • Frame and structure approach, research, analyze and synthesize information and recommendations on the evolving external landscape and internal strategic proposals

  • Perform complex, strategic analysis of Medicaid, Medicare, 340B and VA/FSS data, including advanced forecasting, predictive analytics and trending, in order to proactively address current and future scenario planning

  • Support or lead government pricing regulatory, compliance, and analytics activities pertaining to Medicare, Medicaid, VA/FSS, 340B, and/or state regulations.  Support or lead within GP and across the organization with internal and external stakeholders

  • Maintain assigned government program methodologies, ensure they are kept up to date

  • Partner across GP teams and internal stakeholders to interpret changes in laws and regulations, assess the effect on complex pricing and contracting strategies, government payer claims and rebates, government reporting requirements and help ensure strategic and operational readiness across GP, Channel Operations, Government Affairs and MCCO

  • Act as a lead and/or subject matter expert for others and influence on cross-functional teams and strategic and/or operational projects which may be complex and innovative

  • Work cross-functionally to identify, educate and communicate on changing trends and potential impacts or other implications for Genentech’s current and future business

  • Develop and cultivate strong relationships across team and organization as well as externally with government agencies

  • Create, implement, prepare and publish scorecard reports, various analytics, compliance and other ad hoc reports

  • Ensure audit preparedness and support internal and external audits

  • Develop materials, train and educate others outside of the department

Senior Government Contracts & Strategy Manager

(In addition to the above Government Contracts & Strategy Manager Key Responsibilities)

  • Expertly lead, manage and influence cross-functional teams on strategic, operational, and/or system projects which may be complex and innovative.  Provide issue resolution with high compliant and long-term results while improving upon department efficiency and overall effectiveness

  • Act as a lead and/or subject matter expert and trainer on government payers and programs, as these relate to government pricing, contracting, administration, reporting and related matters

  • Effectively contribute to various management activities across GP, including review and approval processes, development and delivery of training & development programs, leadership in SOP, systems, processes, data, and other tool development and implementation

  • Build relationships and work collaboratively with all internal and external partners and stakeholders including government officials

  • Create and communicate presentations to colleagues and senior management and must be able to communicate insights at various levels to be effective

  • Lead internal and external audits

  • Align, motivate and inspire yourself and others to work in accordance with the Genentech Operating Principles

​​

Key Competency Profile:  The successful candidate will demonstrate the following competencies critical to this role: 

  • Technical and Business Expertise:
  • Have/or able to acquire a deep understanding of government programs and government pricing regulations
  • Have aptitude for and enjoy detailed technical data, apply knowledge to improve results in an operational setting and contribute to overall team success
  • Strategic Agility:
  • Ability to assess complex long term objectives, business strategies, and government regulations, translating these into operational outcomes.

  • Leverage critical thinking and problem solving skills to develop and implement streamlined and compliant business processes and systematic solutions

  • Gathers all necessary information, uses good judgment to make decisions and knows when to escalate decisions to the appropriate level

  • Is aware of what groups or individuals may be impacted by decisions and consults with them throughout the decision making process

  • Is able to articulate the rationale behind any decisions and recommendations made

  • Teamwork and Collaboration:

  • Desire to work in a team environment where the results of the individual contribute to moving the team forward and achieving the team goals

  • Capable of addressing and resolving conflict by creating an atmosphere of openness and trust, establishes strong collaborative relationships within and across teams

  • Decision Making:

  • Demonstrate leadership in Manager’s absence

Qualifications

You are someone who wants to influence your own development.  You are looking for a company where you have the opportunity to pursue your interests across functions and geographies.  Where a job title is not considered the final definition of who you are, but the starting point.

Government Contracts & Strategy Manager

  • Bachelors Degree in areas of General Business, Finance or Public Policy Disciplines is preferred

  • MBA or other related graduate-level degree is a plus

  • A minimum of 4-6 years’ work experience in government programs or related analytics

  • 2 or more years’ experience in the pharmaceutical/biotechnology or related industry, highly preferred

  • Strong knowledge/understanding of drug contracting, government and commercial customers, and the distribution channels

  • Demonstrable knowledge of the different state and federal government agencies that purchase pharmaceutical/ biotechnology or related industry products

  • Demonstrable knowledge of the current policies and guidelines that affect government programs, pricing and payment adjustments (e.g., Medicare, Medicaid, Veterans Affairs)

  • Strong knowledge of systems and reporting mechanisms that support contract administration particular to the pharmaceutical/biotechnology or related industry

  • Must demonstrate a high level of proficiency with Microsoft Excel, and Word

  • Previous experience in other functions within the pharmaceutical, biotechnology or related industry is preferred

  • Working knowledge of relevant pricing and contracting strategy development methodologies and modeling (quantitative and qualitative)

  • Proven track record for consistently meeting or exceeding qualitative, as well as any relevant quantitative, targets and goals

  • Business travel, by air or car, is required for regular internal and external business meetings or conferences

Senior Government Contracts & Strategy Manager

  • Bachelors Degree in General Business, Finance, or Public Policy Disciplines

  • MBA or other related graduate-level degree is preferred

  • A minimum of 5-10 years’ work experience in government programs or related analytics

  • 3 or more years’ experience in the pharmaceutical/biotechnology or related industry, highly preferred

  • Strong knowledge/understanding of drug contracting, government and commercial customers, and the distribution channels

  • Demonstrable/expert knowledge of the different state and federal government agencies that purchase pharmaceutical/biotechnology or related industry products

  • Demonstrable/expert knowledge of the current policies and guidelines that affect government programs, pricing and payment adjustments (e.g., Medicare and Medicaid)

  • Strong knowledge of systems and reporting mechanisms that support contract administration particular to the pharmaceutical/biotechnology or related industry

  • Must demonstrate a high level of proficiency with Microsoft Excel, PowerPoint and Word

  • Working knowledge of relevant pricing and contracting strategy development methodologies and modeling (quantitative and qualitative)

  • Previous experience in other functions within the pharmaceutical, biotechnology or related industry is a preferred,

  • Proven track record for consistently meeting or exceeding qualitative, as well as any relevant quantitative, targets and goals

  • Business travel, by air or car, is required for regular internal and external business meetings

Important Information

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity protections, view the EEO is the poster.

If you have a disability and need an accommodation in connection with the on-line application process, please email us at [email protected].

Genentech will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.