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Key Deliverables

• As the leader for Oncology Personalized Health Care (PHC) and real world data (RWD) partnering, drive business development strategy and execute collaborations in oncology and RWD (including clinical, ‘omic, and clinical imaging data) across therapeutic areas that supports the execution of PHC strategy
  • Build strong knowledge base in PHC, including continual landscaping of potential partners and understanding of competitor actions.
  • Specific focus on oncology and RWD needs across all therapeutic areas
  • Work closely with executive PHC stakeholders within Roche to enable their strategies through actionable external relationships
  • Gain CEC-level alignment for partnership opportunities
  • Lead oncology and RWD PHC transaction execution
• Present recommendations to CEC level management to enable decisions on strategic collaborations and M&A opportunities, including large transformative acquisitions, based on thorough analysis of scientific merit, strategic fit, business case and integration options for an acquisition, conducted jointly with internal stakeholders.
• Manage team of 2 direct report(s) and provide guidance/support on their projects
• As a principal spokesperson for Roche’s PHC and RWD efforts, represent Roche’s PHC vision to the external world at conferences, meetings, and networking events
• Identify new areas for PHC growth/development within Roche and cultivate stakeholder support for these initiatives
• Serve as PHC thought partner to executive-level management

Profile:

• Experienced project leader with experience in corporate development (including negotiations), product forecasting and/or financial valuation. 
• Strong analytical skills and business acumen
• Interest and knowledge of competition and PHC companies (data, analytics, digital) and/or medical imaging
• Ability to work on multi-projects in a fast pace environment, with consistent high quality,
• Ability to autonomously lead projects with ambiguity and share outcomes/recommendations with senior management
• Good influencer, knows how to build alliances
• Strong inclination for learning, with interest and ability to think out of the box
• Comfortable leading, developing, and mentoring less experienced members of team

Qualifications:

• Graduate degree in business or life sciences discipline, MBA or Ph.D.
• Minimum of 15 years of experience in Pharma or Biotech, including significant experience in corporate development, product forecasting and/or financial valuation.
• Robust business development experience with a significant deal sheet
• Proven project management skills and demonstrated leadership of cross functional teams
• Commercial operation or strategic marketing experience a plus
• Experience interacting with and making recommendations to senior management
• Strong entrepreneurial mindset, financial acumen, scientific and M&A know-how, project leadership and management
• Previous management experience

Location:

• SSF

The Product Portfolio Management Office (Product PMO) provides PTR with services in product portfolio management, product project management, TRT program management and knowledge management. The PMO works closely with the Biologics and Small Molecule platforms to deliver a holistic strategic plan for the Biologics and Small Molecules projects portfolio and to identify common regulatory and operational themes and trends between products and projects. The Product PMO collaborates with all functions in PTR to increase efficiencies, productivity and/or quality of the way the Technical Regulatory Teams (TRTs) operate. The Product PMO portfolio management supports product project prioritization; enables the product portfolio resourcing and budgeting processes and facilitates PTR product portfolio reviews. The Product PMO Portfolio Manager will actively contribute to these services. She/he will be responsible of the PTR Product Portfolio (Biologics and/or Small Molecules) and will be responsible to continuously improve processes that the Product PMO uses to resource, oversee, and report on projects at both the project and portfolio levels. As a member of the Product PMO, he/she will drive continuous improvement of the TRT program infrastructure and the collaborations with external partners such as Pharma Technical Development (PTD), Pharma Technical Supply (PTS), Pharma Development Regulatory (PDR), etc.

The Product PMO Portfolio Manager will support the knowledge management efforts in PTR by adhering to processes and fostering behaviors to ensure that critical regulatory information is consistently and easily available to PTR users. The Product Portfolio Manager will be in contact with leaders in key partner organizations regarding TRT and TRL interactions, roles and responsibilities and deliverables.

This role will build effective relationships with Technical Regulatory Leads (TRLs), Technical Regulatory Team (TRT) Members, PTR Operations Business Excellence, and other portfolio stakeholders and consumers of technical regulatory program and portfolio data.

Product Portfolio Management (Biologics and/or Small Molecules) – Develop/Adapt existing processes to accomplish the following:

• Collect product project specific information from TRLs, TRTs, and technical managers including: Technical Regulatory Strategies; Regulatory product health and project execution performance information (adherence to schedule, scope / strategy, resources) and Product and projects risks.
• Aggregate and analyze project data to identify, analyze, and manage portfolio-level trends and generate recommendations to PTR strategy including portfolio/business risk mitigation, staffing levels, workforce skills development, process improvements, cross-platform opportunities, etc. Develop and publish portfolio reports.
• Collaborate with senior management and other stakeholders to identify portfolio data needed for decision making at various governance bodies and levels of functional leadership.

Work closely with the platforms to deliver a holistic strategic plan for their projects portfolio and to identify common regulatory and operational themes and trends between products and projects.

Establish governance and/or organization to manage the product portfolio process. Organize and/or manage the Product Portfolio Reviews. Enable the product portfolio resourcing and budgeting processes.

Develop, implement, monitor and evolve regulatory program management tools, methodologies and processes.

Drive continuous improvement of the TRT program infrastructure and of collaborations with external partners such as PTD, PTS, PDR, etc.

Support the knowledge management efforts in PTR by adhering to processes and fostering behaviors to ensure that critical regulatory information is consistently and easily available to PTR users.

QUALIFICATIONS

Education & Experience:

• MS or Ph.D. in a technical field with 10 years in the biotech industry, including 5+ years proven experience leading and or managing teams in a matrix environment.
• Sound knowledge of drug development processes. Well-versed in technical lifecycle of small molecules and biologics, and familiarity with technical regulatory requirements and planning of regulatory strategy.
• Previous technical regulatory experience a plus.
• Previous people management experience a plus.
• Demonstrates, or has proven abilities to demonstrate PTR and Roche Core Competencies.
• Demonstrates, or has proven abilities to demonstrate Roche Values and Leadership Competencies.
• Strong project management and communication skills.
• Evidence of effective skills in people and team development.
• Highly competent in MS office applications including Excel, Powerpoint, Word, Project, etc.
• Strong influencing skills; consistently achieves targeted results without authority and by leveraging his/her expertise, business knowledge, interpersonal skills, organizational savvy and relationships.
• Strong partnering skills; has exceptionally strong and highly effective working relationships with internal and/or external customers, partners and stakeholders.
• Excellent interpersonal and organizational skills, including understanding of key change management concepts and methodologies; Proven abilities to effectively lead, organize and prioritize work.
• Must work well as member of a diverse global team and in a proactive, positive and collaborative manner; Ability to lead cross-functional teams.
• Comfort around all levels of staff and management; maintains a confident stance, stays focused and on-point, and is able to raise problems or challenges in a productive and competent manner.
• Exceptional skills in assessing, summarizing and presenting business or operational priorities and decision-points for effective, timely and efficient management/executive decision-making.
• Strategic orientation. Can effectively look out several years and project business or operational implications, trends, risks, uncertainties and/or opportunities.
• Able to deal with ambiguity and constant change.
• Able to work independently with minimal supervision.
• Able to function effectively in a fast-paced, multi-tasking environment.
• International or global business experience and cultural awareness preferred.
• Ability to travel up to 20%

Job facts

As part of the Global Operations team we are looking for a full time infrastructure engineer based in Madrid for our HPC environment.

Your mission will be to manage agile computing environments in several locations to support our Research partners on supporting the relevant infrastructure components to achieve agility and performance. This includes installing, configuring, administering, and fine-tuning our High Performance Computing environment and related infrastructure components across the organization in a timely, cost-effective and efficient manner.

Your main responsibilities will be:

• Assist on the design of the new HPC infrastructure and evolution of the current environments.

• Ensures installation, configuration and operation of the environments to achieve the performance and agility of the various applications supported (in the range of several hundreds).

• Contributes to the concept, planning and execution of projects.

Who you are

You’re someone who wants to influence your own development. You’re 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.

• Experience in fast changing environments where solutions are deployed and retired at high pace.
• Problem solving attitude
• Senior level technical operational skills, such as troubleshooting, capacity planning, and root cause analysis
• Excellent customer orientation and delivery focus with good end user perspective
• Good communication and interpersonal skills
• Advanced English language skill is a must
• Ability to work effectively alone or within a team, including virtual teams
• Clear goal orientation and supportive of change
• Proactivity, with a clear ability to think beyond boundaries, take controlled risks and assume responsibilities
• Desired understanding of Computer Systems Validation and ITIL concepts
• Experience in a global organization, working in an international and multicultural environment is considered a valuable asset
• A second language among: Spanish or German would be considered an advantage.
• Active open source contributor
• Working experience in pharmaceutical or scientific/research sector is an advantage

Technical skills

Specialist Profile

Mandatory:

• More than three years of experience, and at least HPC knowledge (High Performance Computing)

• DevOps Mindset

• Linux Administration and Scripting (other programming language)

• GPFS basics

• Configuration management (GIT/Stash, Puppet, and basic Bright knowledge)

• Used to work in international environment, and fluent in english
   

Basics knowledge in:

• Dockers: Mesos/Marathon, DC-OS

• Monitoring: Ganglia, Grafana, ELK, Influxdb

• Provisioning: Katello/ Foreman, Jenkins

• Network: Mellanox

Senior profile:

Mandatory:

• More than 5 years of HPC experience (High Performance Computing)

• DevOps Mindset

• Linux Administration and Scripting (other programming language)

• Configuration management (GIT/Stash, Puppet, and basic Bright knowledge)

• Used to work in international environment, and very fluent in english

Advance knowledge in:

• GPFS

• Monitoring: Ganglia, Grafana, ELK, Influxdb

• Provisioning: Katello/ Foreman, Jenkins:

Basics knowledge in:

• Network: Mellanox

• Dockers: Mesos/Marathon, DC-OS

Summary:

As a Validation Engineer / Manufacturing Technical Specialist in our South San Francisco Production organization, you will be responsible for a variety of validation activities and for resolving challenging issues following cGMP regulations and company standards.

General Job Responsibilities

• Maintain a state of inspection readiness.
• Provide input to the development of personal performance goals and departmental objectives.
• Collaborate with Management to establish and meet targets and timelines.
• Support routine operations and allocate assigned resources.
• Manage competing priorities.
• Serve as the Validation representative on cross-functional and multi-site teams.
• Identify, design, and implement process and system improvements.
• Lead and participate in the design and implementation of department and cross-functional initiatives.
• Apply advanced theory, technical principles, and expert judgment to address a broad range of difficult problems.
• Troubleshoot and direct the resolution of Validation issues by fostering effective interdepartmental and cross-functional partnerships.
• Serve as a technical subject matter expert (SME) in support of department functions.
• Train personnel and internal customers on relevant business processes.
• Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.
• Be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies.
• Follow company policies and procedures.

Specific Job Responsibilities

• Manage equipment, utility, process, and facility validation and revalidation projects.
• Develop validation and revalidation project plans.
• Act as project manager for validation teams ensuring new systems are implemented within predetermined timelines and financial forecasts.
• Validate equipment, utilities, processes and facilities.
• Prepare validation protocols.
• Coordinate the collection, testing, and analysis of samples and reporting of results required per validation protocol.
• Collaborate with departments to ensure validation activities are executed efficiently and effectively.
• Prepare validation summary reports for validation activities.
• Review and approve validation documentation.
• Provide technical assessment and approval for engineering and process changes.
• Provide input into investigations with potential validation impact.
• Present and provide rationale for the validation program during periodic audits and regulatory inspections.
• Prepare, review, and approve relevant sections of regulatory submissions.
• Procure and manage contractor support for outsourced validation assignments.
• Develop and administer a change management system for validated equipment, utilities and facilities
• Provide input into the design and presentation of department performance metrics.

Job Requirements

Minimum requirements include the following:

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, Industrial Engineering, Life Sciences or other relevant discipline
• 2+ years of post-Bachelor’s experience in at least one of the following: relevant engineering role OR hands-on biopharma manufacturing role OR advanced degree in a relevant discipline
• Experience with purification, fermentation and/or drug product processes is preferred
• Demonstrated knowledge of cGMPs or equivalent regulations
• Experience interpreting Quality standards for implementation
• Ability to independently evaluate situations and propose potential solutions
• Ability to communicate clearly and professionally both in writing and verbally
• Strong problem solving capabilities
• Experience with project management, including identifying resources and setting work priorities and timelines
• Flexibility with work hours to meet business needs

We are seeking applicants for this position who reside locally in the San Francisco Bay Area. No relocation. Only local candidates will be considered.

Job facts:

If you are energized by cutting edge science and want to make an immediate impact in the area of CARDIAC products as part of a great team, Roche Diagnostics may just be your next great career choice!

This role is for a field-based Medical Science Liaison (MSL), within the Roche Diagnostics Medical Affairs department. You will play a highly visible role in our company with critical relationships across the medical/scientific community, by communicating CARDIAC product-related information to investigators, clinicians and institutions. 

The opportunity:

• Provides information on research development and changes in standards of care and medical treatments, giving perspective to field activities associated with growing existing products and bringing new products to market.
• Builds relationships and demonstrates the clinical outcome and benefits of company products to regional Key Opinion Leaders
• Facilitates scientific discussions in cardiac care and cardiac biomarkers and works with other in-house and field partners to facilitate ongoing information/clinical data sharing (ie. new data, competitive information, insights learned from customer) to optimize communications and coordinated activities across the organization
• Stays abreast of emerging scientific literature/clinical data, translate the data in applicable knowledge, and provide scientific input in the development of Medical Communication material
• Partner and collaborate effectively with internal business partners, especially with members of the clinical teams
• Stay abreast of emerging scientific literature/clinical data, translate the data in applicable knowledge, and provide scientific input in the development of Medical Communication material

Who you are:

• Bachelor’s degree.  MD, PharmD, DNP or PhD in clinical field strongly preferred.
• 5+ yrs. related cardiac clinical/practice experience. Extensive clinical experience preferred.
• Ability to develop and maintain collegial relationships with specialists and generalists within respective fields, as well as nurses, researchers, and laboratory professionals
• Ability to lead, direct, influence and empower multi-discipline teams and individuals
• Ability to successfully interface with senior management (within and external to company)
• Excellent communication, conflict management, analytical, problem solving, decision-making skills
• Ability to travel 50-60%

Note: Currently there is one vacancy available in each territory.

This is a remote based position. Candidates can reside in CA, WA, OR, NV, ID or AZ

Job facts:

Lead and develop the Medical & Scientific Liaisons in their relationships with the medical/scientific community, with the objective of critical scientific exchange including medical/scientific education and responses to unsolicited “off label” inquiries to support healthcare professionals as well as internal Roche scientific groups and local business teams.

Specialized and in-depth comprehensive knowledge and experience in a particular field, or business area. Duties are varied and complex often involving research, analysis and solution development. Provides direction on issues of area of expertise and assist department leadership in setting strategic direction. Typically a higher level professional position. Requires the regular use of originality and ingenuity. Possesses and applies a broad knowledge of principles, practices and procedures of field. Is generally assigned more complex and difficult assignments. Assignments are broad in nature. Typically works with greater discretion and latitude. May assist Consultants and lower level staff by providing advice and guidance.

Responsible for maintaining and continuously improving the quality system and achieving quality objectives through daily actions.

The Opportunity:

• The Regional Scientific Affairs Manager will:
• Maintains all of the Medical & Scientific Liaisons (MSL) responsibilities and competencies in the MSL job description. Additionally, assists with strategic customer engagements and thought leaders activities
• Assists with recruiting, hiring, training and maintaining highly skilled field-based MSL. Provides direction, coaching and development of MSLs. Engages in direct observation and assessment of assigned MSLs on at least a quarterly basis. Provides verbal and written feedback on performance. Assists with establishment of and progress toward individual Objectives for assigned MSLs.
• Assists with identification of educational needs and opportunities for MSLs. Assists with coordinating MSL attendance at appropriate scientific meetings.
• Facilitates and develops the relationship with the medical/scientific community, by communicating product- related information to investigators and institutions. Provides information on research developments and new concepts in medical treatment and scientific technology, giving perspective to field activities associated with growing existing products and bringing new products to market.
• Skilled in offering high level technical support to customers, sales and marketing. Addresses customer’s scientific inquiries (on-label and off-label unsolicited requests), documents requests and actions, troubleshoots issues and customer applications at site.
• Disseminates project information/customer interaction. Attends appropriate U.S. and international scientific congresses, develops in-depth understanding of clinical practices and regulations, and maintains understanding and insight into current lab and clinical practices and guidelines.
• Assists Director in regular staff meetings and other group activities and functions.
• Accountable for identifying, collecting, and holding accountable the KPIs and metrics.
• Nationwide travel of 50-60% within assigned MSL territories

Who you are:

• To be successful you will hold a Master’s Degree in Nursing, Business, etc
• Previous management experience
• 5+ years previous related clinical/practice experience
• Ability to develop and maintain collegial relationships predominantly with specialists and generalists within respective fields, as well as nurses and laboratory professionals
• Ability to lead, direct, influence and empower multi-discipline teams and individuals
• Ability to successfully interface with senior management (within and external to company)
• Capacity to manage conflict
• Excellent oral and written communication skills
• Ability to prioritize work and manage multiple projects and assignments simultaneously
• Strong analytical and problem solving skills; Strong judgment and decision making skills
• Ability to think strategically
• Ability to develop and maintain deep relationships with thought leaders and healthcare professionals
• Ability to quantify metrics

Preferred Skills:

• Doctorate level education (MD, PhD, PharmD)
• Knowledge of Roche Diagnostics products.
• Clinical Cardiac experience strongly preferred

Team Coordinator Global Medical Device Management (m/f)

POSITION SUMMARY

The Team Coordinator Global MDM works independently and leads Supplier Quality Oversight from Supplier selection / design development phase to post commercial phase for purchased medical devices, medical device components and constituent parts for Combination Products (collectively referred to as Medical Device direct materials hereafter).

Main Responsibilities:

• Lead Device Supplier Quality oversight activities in accordance with the applicable regulations, guidelines, GMP and Roche standards

• Evaluate and solve a wide range of complex issues that affect multiple functions / sites related to direct material discrepancies, market complaints and associated investigations, in accordance with the applicable regulations, guidelines, GMP and Roche standards

• Initiate, assess, and manage vendor initiated changes and third party actions for Roche initiated change in accordance with applicable regulations, guidelines, and Roche standards

• Perform audits of direct material suppliers according to the Supplier Quality Management Audit Program

• Monitor and Trend the performance and risk level of assigned Suppliers, Identify, Define and Implement Supplier corrective and improvement projects by proactively collaborating with Functions / Sites and Suppliers to enhance the quality and supply of direct materials

• Create and Negotiate Quality Agreements. Provide quality requirements and negotiate final Supplier Specification

• Participate in due diligence assessment for Supplier selection, Lead Supplier qualification and maintain its approved state through consistent satisfactory performance.

• Strive to meet company and department goals and metrics

• Drive continuous improvement objectives through end-to-end lifecycle management of processes and application of LEAN principles

Who you are:

• Master or university degree in engineering, pharmacy, life sciences or equivalent

• Additional qualification in cGMP or auditing

• at least 12 years of experience in pharmaceutical or medical device industry in the area of Quality Assurance, Quality Control, Production or Development, or an equivalent combination of education and experience in combination products, aseptic manufacturing and working in matrixed and global environments is preferred

• Hands-on experience in medical device manufacturing

• Demonstrated capability of applying risk management concepts and tools, and Design Control

• Sound knowledge of Pharma and Medical Device GMPs, ISO standards and applicable international regulations, including but not limited to, Quality Systems Regulations and EU Medical Device Directive, ISO 13485, ISO 14971, ISO 9001, 21CFR Part 4 and Part 820.

• Ability to interpret and apply Quality Standards related to Roche products and suppliers

• Understanding of primary container and drug product manufacturing processes, laboratory test methods to include EP, USP, JP requirements, and industry standards preferred

• Demonstrated teamwork, collaboration and influencing skills and relationship management with third parties, and ability to communicate clearly and professionally both verbally and in writing.

• Demonstrated problem solving and decision making skills including hands on working experience with basic statistical tools. Six Sigma / LEAN knowledge is preferred

• Knowledge in analytical methods, risk assessment and project management is beneficial

• Excellent in written and verbal communication and negotiation in a difficult and complex environment in English; German would be beneficial

• Responsible for setting own goals and tasks after discussions with superior

• Ability to lead a small group of people

• Manage a cross-functional team in a matrix structure (e.g. in an audit, material review board)

• Moderate effects on several departments or interests

Willingness to travel (up to 30% domestic and international travel)

Who we are:

With more than 12,000 employees Roche Diagnostics GmbH (RDG) represents the third largest site within Roche. Apart from the two sales organizations in Germany (Roche Pharma AG and Roche Diagnostics Deutschland) RDG is focused on the operative business. At the two sites in Mannheim and Penzberg new diagnostic tests and pharmaceutical active ingredients are developed and produced for the global market.

Roche is an equal opportunity employer.

Summary of Position:

The PV Clinical Specialist supports the drug safety staff in the strategic and operational job responsibilities, including but not limited to the collection, clinical review, evaluation, and processing of adverse event (AE) information received by US Drug Safety.   The PV Clinical specialist is responsible for the oversight of study related activities in collaboration with other functional groups, serves as the single point of contact with Pharma Development Safety Science, and supports the US Drug Safety  PV Clinical Manager- Specialist in all activities. All responsibilities are performed under the direction of the PV Clinical Manager- Specialist.

Key Accountabilities (The E4 and E5 PV Clinical Specialists will perform some or all the following activities):

• Functions as the subject matter expert for all types of case processing, provides guidance, and oversight of ICSR quality within PV Clinical Team

• Provides strategic input on case processing activities performed by the PV support team
• Performs trend analysis for ICSRs processed in global safety database
• Provides feedback and escalates [if required] to PV clinical management of any trends observed
• Assists senior PV specialists in performing enhanced follow up activities [as required]
• Assists in case process related activities during audits and inspections
• Demonstrates expertise of appropriate labeling documents for Genentech/ Roche molecules and products and performs labelling assessment for AE(s) received using clinical knowledge
• Demonstrates understanding of local and global health authority requirements pertaining to ICSR processing

• Responsible for maintaining compliance with health authority regulations and guidance documents pertaining to ICSR submissions
• Responsible for the oversight and implementation of internal Manuals, global / local safety SOPs / Work Instructions (applicable to USDS) and external collaborations agreements, e.g. PVAs and SDEAs
• Responsible for the oversight of identifying, creating additional, or updating existing local Guidance Documents including but not limited to training matrix, identify appropriate target audience for training assignment
  • Demonstrates expert knowledge of protocol management in accordance with PV related standards, regulations and Genentech/Roche Standard Operating Procedures (SOPs) in order to oversee and lead the protocol review process for sponsored/managed and supported/funded studies for molecules/products in assigned therapeutic areas

• Accountable for providing PV oversight to appropriate study/molecule teams
  • Accountable for Post Authorization Safety Assessment (PASS) classification for all Genentech /Roche sponsored and supported studies based on medical knowledge and European Union (EU) regulations
  • Reviews Safety Data Exchange Agreements and Safety Management Plans (as applicable)
  • Responsible for the assignment of molecule and therapeutic area assignments and tracking
  • Reviews Safety Data Exchange Agreements and Safety Management Plans and provides guidance on related documents (as applicable)
• Actively participates as a member of the Study Management Team and performs PV activities including but not limited to: Providing presentations for investigator meetings, oversee clinical trial reconciliation and/or Case Transmission Verification (CTV)  (as applicable), acts as a single point of contact for safety related concerns, and acts as a safety liaison between safety science, Study Review Team (SRT), Study Management Team (SMT), and any similar governing bodies.

Oversees Safety related activities for assigned Genentech/ Roche Product(s) managed by US Medical Affairs to include

• Demonstrates advanced knowledge of the safety profile to include comprehensive working knowledge of appropriate labeling documents for assigned Genentech/ Roche Product(s)
• Provides medical team molecule support in appropriate safety areas
• Advises medical teams conducting interventional or non-interventional research that improves the care of patient from safety perspective
• Independently oversees signal detection and validation for aggregate data received by USDS (e.g, PBRER, PSUR etc.)
• Responsible for ensuring oversight and appropriate classification of all activities under USMA
• Exhibits total knowledge of study classification (i.e, interventional studies, non-interventional studies, post-approval safety studies (PASS), registries, etc.)
• Communicates and updates Team of any process related issues/ concerns
• Acts as single point of contact for safety related concerns
• Acts as Safety Liaison between Safety Science and Medical Team.
  • Expert knowledge of the Genentech/ Roche Product(s) safety profile(s) and appropriate labeling documents
  • Provides guidance on the medical review of safety related documents, including but not limited to pregnancy letters and develop a plan of action to mitigate any risk
  • Prepares written responses to drug safety queries from Health Care Professionals using the locally available information and/or initiating literature searches as required and/or initiating an investigation by Drug Safety Contact Line (global) as needed
  • Responsible for implementation of Risk Management Plans (RMP) / Risk Minimization activities or Risk Evaluation and Mitigation Strategies (REMS) for assigned molecules / products, with the ability to function as the RMP IC (as required)
• Responsible for performing and overseeing health authority submissions via thorough understanding of FDA regulations as per code of Federal regulations (CFR)
  • Responsible for regular review of US submission rules within the safety database
  • Acts as a single point of contact for submission related inquiries
  • Liaises with internal/external stakeholders (i.e., PV information system, PDSS, regulatory, health authorities as applicable) to understand and implement regulatory requirements or any applicable changes
• Develops, performs, and provides input on drug safety presentations for internal /external stakeholders as applicable.
• Responsible for identifying any deviations or process improvements including corrective and preventive actions Contribute PV expertise to Genentech work products and coach/mentor others as needed
• Act as a guardian for high standards of compliance, ethics and safety; putting patients at the center of all actions
• Manages all PV related activities or commitments are appropriately actioned for assigned therapeutic areas which include but not limited to overseeing all study activities performed by individual molecule responsible
• Participates in preparation on abstracts, posters, and presentation for medical/ scientific meeting and/or congresses based on the collaborative initiatives

• Acts as single point of contact with key stakeholders for safety related activities and acts as Subject Matter Expert (SME) for safety related activities within Global Safety Database per Genentech/Roche SOPs.
• Works closely with PV Clinical Manager to be aware of any safety issues / concerns and assist or leads special projects as assigned by and under the direction of the US Drug Safety PV Clinical Manager and/or other Safety personnel.
  • Provide support during audits and inspections.
  • Collaborates with PV Operations and SP PV Oversight teams as needed

E4 PV Clinical Specialists

The PV Clinical Specialists demonstrates expert knowledge of protocol management in accordance with PV related standards, regulations and Genentech/Roche Standard Operating Procedures (SOPs) to oversee and lead the protocol review process for supported/funded studies for molecules/products in assigned therapeutic areas under limited direct from the PV Clinical Specialist Manager. PV Clinical Specialist also provides guidance to PV Clinical Support staff as needed. Accountable for providing PV oversight to appropriate study/molecule teams and for activities concerning SRT or other similar governing bodies

E5 Senior PV Clinical Specialists - Expert in all PV Clinical Specialist activities in addition to the following:

Demonstrates expert knowledge of all PV clinical related activities and provides guidance to PV Clinical Specialist and support staff. Is also primarily responsible for all sponsored studies and medical team (or similar governing bodies) related activities.

Provides strategic input in collaboration with the PV Clinical Managers / PV Clinical Head and can work independently within PV Clinical activities. Acts as an expert on Health Authority Regulations and supports PV Clinical Managers with interpretation of these regulations. Takes accountability for cross-functional projects and achieves desired results with minimal supervision. Identifies process improvements, establishes new standards and techniques to improve PV standards and compliance as required.

Competencies Identified for Success:

• Demonstrates capability to comprehend, and analyze medical information
• Works effectively, independently and collaboratively
• Strong organizational skills, detail oriented and adapts in a fast paced, changing environment
• Demonstrates ownership, initiative, accountability, and the ability to manage change
  • Strong customer orientation/focus
  • Ability to flex and thrive in an agile and fast changing environment
  • Works well independent or within teams and is effective in collaborating with others internally and externally
  • Analytical and problem-solving capabilities and skills. Has demonstrated the ability to anticipate and solve problems and effectively make decisions of moderate complexity and scope e.g. evaluate, interpret and present highly complex data
  • Communication and presentation skills; highly effective at summarizing and presenting key considerations and decision-points
  • Ability to effectively and efficiently manage multiple priorities

• Good interpersonal and influencing skills; can effectively and quickly establish rapport with all key internal/external partners and stakeholders and influence without authority
• Good negotiation skills: can drive discussions and decisions towards desired results
• Understanding of legal and regulatory considerations impacting pharma/biotech industry and ability and judgement to apply principles to daily activities
• Strong attention-to-detail

Education, Experience, and Other Requirements:

• Health Care Professional bachelor degree with strong academic background (e.g. RN/BSN/MSN, NP, RPh/ PharmD/ B.Pharm or MD) (Required)
• Demonstrates expertise in computer skills and database experience (i.e Microsoft office Suite) (Preferred)

• Able to travel as per business needs
• 1-3 years of pharmaceutical/biotechnology relevant industry experience preferred - preferably in Medical Affairs or product development or is a recognized expert in the field or therapeutic area (with a minimum of 2 years’ clinical experience)
• Considerable experience in the principles and techniques of data analysis, interpretation and clinical relevance, medical writing
• Proven record in developing strong relationships with external constituents (therapeutic area experts, external organizations, etc.) preferred
• Understanding of and/or previous experience with Phase I - III and/or Phase IV drug development 
• Considerable experience in the principles
• Proven track record of meeting or exceeding objectives and goals

 #LI-COMM-RS

The Position

We seek a highly motivated, productive, and creative Senior Scientific Researcher to join our endeavor in basic neuroscience research and pursuit of innovative treatments for CNS diseases. The individual will use a variety of neurophysiological and molecular/cellular techniques to investigate basic mechanisms of neurological disease and identify new therapeutic targets.  Areas of interest include understanding the roles of neural circuit dysfunction and neuroinflammation in neurodegenerative conditions.  He/she will be expected to independently design, execute and analyze experiments, as well as frequently interact and communicate with other groups as part of a diverse and multidisciplinary team. This is a hands-on laboratory position with abundant opportunity for collaboration with other researchers in a highly dynamic and fast-paced environment.

Who You Are

Applicants should have a relevant PhD with a strong research background in neuroscience or related fields. The ideal candidate will combine research experience using electrophysiological/imaging approaches and biochemical/cell biological approaches.  A track record of completing challenging technical problems independently and creatively, exemplified by publication of research in high-quality scientific journals is required.

In hiring new employees, we look for people who are also inspired by our mission and who would fit in well with the collaborative, rigorous and entrepreneurial spirit of the company culture. We are seeking an individual who is self-motivated, collaborative, hard working, and possesses a proactive attitude and a strong desire to discover novel biology and potential new drugs. Efficient time management, excellent organizational and communication skills, and passion for high-quality, translational science are essential.

This Lifecycle Leader (LCL) will lead TECENTRIQ GU Lifecycle Team (LCT) and is accountable for an aligned product vision, strategy and all activities governed by the Late Stage Portfolio Committee, including full fiscal accountability of Project Variable Costs (PVCs) and Global Product Marketing Costs (PMCs) and is accountable for all global commercial activities within the scope of the LCT, which presently includes bladder, renal and prostate programs. This position is a global role based in San Francisco. The LCL is the leader of the Lifecycle Team & line manager of International Business Leader.

Responsibilities:

• To act as the "General Manager" for TECENTRIQ GU.

• To provide strategic leadership to the TECENTRIQ GU LCT, a multifunctional team covering preclinical, technical, manufacturing, development, and marketing activities.

• To make recommendations to the Late Stage Portfolio Committee to maximize the value of TECENTRIQ GU over the entire lifecycle (as captured in the Strategic Lifecycle Plan, Product Development Plans, Strategic Launch Plans).

• To develop a vision for TECENTRIQ GU by leading the process of developing a target positioning built on the target product profile, key claims and documented market insights.

• To mobilize the organization's implementation of the Lifecycle Strategic Plan, ensuring alignment of development and marketing plans - in line with the target product profile.

• To lead the Lifecycle Team to prepare the Product Development Plan and Strategic Lifecycle Plan as an integrated development and commercial plan agreed with functions and key affiliates.

• To collaborate effectively with the TECENTRIQ Cross-Indication Team and other TECENTRIQ LCLs to ensure an integrated and aligned position for the molecule.

• To produce the commercial assessment of TECENTRIQ GU Phase I-III results.

• To ensure proper staffing of the LCT and key sub-teams.

• To ensure that the approved plans are implemented globally and in the key affiliates.

• To ensure proper expert peer review of plans throughout the organization.

• To drive relevant licensing activities in relation to projects.

• To serve as GU point person within GPSO including leading strategic initiatives beyond TECENTRIQ

Qualifications

• Bachelors Degree (marketing, business management or life sciences discipline is preferred)

• MBA, MD, PhD or other relevant Graduate or Post-Graduate Degree is preferred

• 12 or more years’ multidisciplinary experience in the pharmaceutical/biotechnology industry

• 5 or more years’ people management experience

• Experienced leader with proven results in people leadership and talent

• Proven experience as an inspirational, empowering leader in a strategic multifunctional environment.

• Exercises good judgment in decision-making, and understands how to work with a cross-functional team to gather appropriate inputs, challenge ideas, and come to a clear decision utilizing a single-decision-maker model.

• Has managed complex projects with ambitious milestones in high-pressure circumstances.

• An experienced leader with proven results in coaching and developing direct reports – proven track record of human resources management.

Beneficial Experiences/Qualifications

• Marketing or commercial experience and/or degree

• Scientific or medical degree and experience is advantageous

• Global/US launch experience is highly valued.

• Has been a sub-team leader and worked in a Lifecycle Team as a core team member over a sufficient time period to have achieved a significant milestone (phase III implementation; NDA submission and approval, launch).

• Has worked on a project that required activity/milestone achievement to 'file' the compound and/or prepare/launch the product.

• Market-relevant experience of therapy area, including the competitive landscape and Key Opinion Leaders is an advantage.

• Experience with phase 3 development and conduct and NDA filing and approval is highly valued.

Start Date: October - December 2018

Job Title: People & Organization Capability Intern

Division: Pharma Medicines 

Department: Regulatory Affairs (PDR) 

Location: South San Francisco

Reports to: Capability Development Lead (CDL) for Build People & Organization Capability (BP&OC)

Job Type: Intern

Employment Type: 1 year, with option to extend

Description of Work

This position will provide an intern with practical professional work experience in a corporate learning and organizational development and within the biopharmaceutical industry.

The Position:

Product Development Regulatory (PDR) Organization Development Team is a small team of experienced leaders with diverse skills and expertise focusing on Organizational and People Capability Development and Change Management. Our group's aim is to develop PDR’s organizational and people capabilities - skills, knowledge, behaviors and mindset - to effectively meet the evolving business needs of the future through innovative approaches. 

PDR OD Focus Areas

Learning and Development

• Provide educational solutions based on current and future business needs that build organizational and people capabilities within PDR

Team and Functional Excellence

• Meeting Design, facilitation and consultancy along the lifecycle of PDR Strategy teams, Leadership Teams, RAFTs to ensure teams achieve desired outcomes

Change Management

• Consultancy on the process, tools, and techniques to manage the people side of change to receive a desired business outcome (includes CM for PDR strategy)

PDR Strategy: Build People and Organisation Capability

• Define, build and manage a holistic people development framework and system aligned with the business strategy to enable the systematic, focused and consistent continuous development of regulatory professional skills, knowledge and behaviors

As part of the PDR Strategy on building People & Organization Capability (BP&OC), we are activating two initiatives in October 2018, that will last through 2019. Initiative #1 is to build the BP&OC Framework and Initiative #2 is to Develop the PDR User Experience.  We are looking for an intern, to work on strategy initiatives as well as work on learning and development deliverables.  This is a meaningful position for an individual who wants to have a significantly positive impact on delivering value and deliver on the promise of readying the workforce for the future and contributing to the overall PDR employee experience as our business evolves.

Responsibilities

• Assist with key deliverables associated with the BP&OC initiatives, including process design, inventory of current competencies, L&D content, competency to role mapping, learning to role mapping.
• Assist with global stakeholder engagements, project planning, meeting facilitation to progress the initiative deliverables.
• Assist with the development of training programs for broad business topics.
• Assist with designing training materials and activities.
• Assist with the research and development of L&D technologies, including digital learning tools to improve learner experience
• Other internship-related duties as assigned.

Qualifications

• Must be available to work full-time for a year
• Recently completed an undergraduate or masters degree in in Industrial or Organizational Psychology, Organizational Development, Human Resources, Education, Instructional Design or MBA with an emphasis in Organizational Development or Organizational Behavior
• Ability to communicate effectively, both oral and written, with proper spelling, grammar and punctuation.
• Ability to manage workload effectively including planning, organizing, prioritizing and meeting deadlines.
• Experience with Google Productivity Tools (primarily gDoc, gSheet, gSlides, gMail, gSites and gDrives). Visio skill are preferable.
• Willingness to learn and collaborate with diverse workforce environment
• Good at building and fostering relationships
• Detail-oriented
• Self-starter, independent, action-oriented and takes initiative
• Loves to bring ideas to life in a creative way

This position is within the Evidence for Access (E4A) Medical Unit in US Medical Affairs. E4A’s aim is to support GNE’s portfolio of products and document their impacts on patients, family members/care givers, and constituents in the health care system (i.e., hospitals, payers, providers, integrated networks, accountable care organizations, etc.) via robust Health Economic & Outcomes Research (HEOR) and Health Services Research programs and agendas. The E4A Medical Unit also supports the mission of conducting research “above” the GNE molecule and/or disease state; such research efforts address questions related to overall effectiveness of patient care, identification of improvements needed in the health care system, and the impact of various policies on aspects of the health care system.

The Health Policy and Systems Research function (HPSR) in E4A focuses on leveraging policy and health services research techniques and methodologies to execute scientific inquiries designed to inform and improve overall population health, health care delivery, and access to health care. HPSR evaluates implemented health care policies, and, as appropriate, will be utilized to further inform the US health policy debate. The E4A Health Policy and Systems Research function is responsible for executing research strategies that reinforce the following:

The role of GNE therapies in the health care system; GNE’s leadership and participation in the creation of health care system solutions with stakeholders; GNE’s credibility in policy-related discussions; GNE’s contributions in providing the scientific evidence that can be translated into improved clinical practice.

This position:

• Reports to the Head of Health Policy and Systems Research, Evidence for Access (E4A) Medical Unit of US Medical Affairs (USMA).
• Will conduct research in collaboration with large, national health systems related to health care services and health care quality impacting access, delivery and outcomes. And, when appropriate, investigates potential impact(s) of GNE’s portfolio on such aspects of the health care system.
• Will be the single point of contact for systems research with large, national health systems, providing strategic oversight regarding research engagement and communication/dialogue, developing and executing health services-specific research priorities, strategies, and tactics.
• Will collaborate with therapeutic areas to inform and execute against policy and health systems research strategies.
• Works the with Head of HPSR to propose and establish cross-therapeutic area strategies, objectives, priorities, processes, budgets, metrics, and other resources needed to foster innovative, effective, and efficient execution and dissemination (e.g., peer reviewed publication) of policy and health systems research activities with large national health systems
• Works closely with external stakeholders (e.g., industry organizations, professional societies, patient advocacy organizations, health care agencies, etc.) to conduct health systems research that can inform the US access environment on behalf of GNE.
• Provides insights to E4A MU regarding US policy and health systems research findings to understand implications for GNE and further inform GNE policy-related positions and business decisions related to large national health systems
• Monitors adherence to company policies and guidelines and acts according to established procedures to ensure all issues are addressed and resolved as required.

Key Position Responsibilities:

RESEARCH STRATEGY and EXECUTION

• Develop robust health services research agendas with large, national health systems
• Execute research strategies and projects that include, but are not limited to, the following topic areas: access to health care (e.g., evidence-based pathways and guidelines, barriers to access, reimbursement and coverage policy), economics of health care (e.g., cost of care, financing of care, MACRA, relationship between experience, outcomes, and costs), demand for health care (e.g., aging of America, health care workforce and capacity, and population health), and the role of pharmaceuticals/biotechnologies in health care (e.g., value and indication-based pricing, pharmaceutical pricing, value-based contracting).
• Execute health services research strategies and tactics that focus on, but are not limited to, the following topic areas: delivery of health care (e.g., patient journey, information flow and exchange), efficiency of health care (e.g., care coordination, variations in care), quality and effectiveness of health care (e.g., care models, use of quality measures), and patient-centered health care (e.g., patient experience, quality of life, patient preference, patient satisfaction).
• Ensure that all research activities are strategically aligned with other functions within E4A, including E4A Molecule Research/TA research activities, and additional GNE stakeholders (e.g., Government Affairs, MCCO, etc.) as appropriate.

EXTERNAL PARTNERING, ENGAGEMENT AND PRESENCE

• Develop relationships and collaborate with critical Thought Leaders in the transformative science and health care system research
• Lead E4A relationships with large, national health systems to shape and inform research methods and policies related to transformative science, health care services research, and health care policy topic areas.
• Leverage key external partnerships as appropriate to facilitate execution and publication of transformative science and access.
• Routinely disseminate and communicate E4A-related health services research findings externally (e.g., publications, white papers, presentations, research reports) and to Genentech senior leadership (e.g., through presentations and newsletters).
• Collaborate with internal and external stakeholders to ensure alignment with Genentech positions; maintain internal relationships with health services-related functions across Genentech.

ORGANIZATIONAL ACCOUNTABILITY

• Act in complete & total compliance with all laws, regulations and policies.
• Establish annual and longer-range plans, goals and objectives, and effectively align these with Genentech and Roche cross-functional Research, Development and Commercial strategies and objectives.
• Develop and track metrics related to deliverables and impact of health systems research programs.
• Assume leadership role in HSPR driving and executing select initiatives.

Qualifications - External

• Doctoral level degree in a relevant discipline (MD, PharmD, health economics, public health, health services research, epidemiology, psychology disciplines are preferred).
• 8+ years relevant healthcare industry experience that includes working successfully within a highly matrixed environment.
• 8+ years of experience in assessment of the clinical and economic value of healthcare interventions and/or systems and/or programs.
• Extensive knowledge of health economics, public health, value assessment, drug information, clinical research and development methods, decision-analytical modeling, marketing, payers, formulary processes/practices, and health services research.
• In-depth understanding of the U.S. health care system and marketplace.
• Established relationships with health service researchers/thought leaders in large US health systems
• Strong leadership skills and prior experience (6+ years) leading teams of researchers with/without direct authority.
• Previous experience in other functions within the pharmaceutical, biotechnology or related industry, e.g., research, development, medical affairs, marketing, market research, managed care, strategic planning, finance, health care consulting, etc.
• Proven track record for consistently meeting or exceeding research goals for larger-scale organizations in the pharmaceutical/biotechnology/or related industry.
• Demonstrated strategic thinking skills and ability to identify and drive creative approaches to tackle large issues and opportunities.
• Comfort and skill in working in undefined, ambiguous environments.
• Demonstrated analytical and problem-solving skills.
• Demonstrated skill in planning and execution.
• Demonstrated strong communication skills (writing, conversation, facilitation, presentation) and excellent interpersonal skills.
• Track record of high performance and results. Business travel, by air or car, is required for regular internal and external business meetings.

  This position is within the Evidence for Access (E4A) Medical Unit in US Medical Affairs. E4A’s aim is to support GNE’s portfolio of products and document their impacts on patients, family members/care givers, and constituents in the health care system (i.e., hospitals, payers, providers, integrated networks, accountable care organizations, etc.) via robust Health Economic & Outcomes Research (HEOR) and Health Services Research programs and agendas. The E4A Medical Unit also supports the mission of conducting research “above” the GNE molecule and/or disease state; such research efforts address questions related to overall effectiveness of patient care, identification of improvements needed in the health care system, and the impact of various policies on aspects of the health care system.

  The Health Policy and Systems Research function (HPSR) in E4A focuses on leveraging policy and health services research techniques and methodologies to execute scientific inquiries designed to inform and improve overall population health, health care delivery, and access to health care. HPSR evaluates implemented health care policies, and, as appropriate, will be utilized to further inform the US health policy debate. The E4A Health Policy and Systems Research function is responsible for executing research strategies that reinforce the following:

• The role of GNE therapies in the health care system;
• GNE’s leadership and participation in the creation of health care system solutions with stakeholders;
• GNE’s credibility in policy-related discussions;
• GNE’s contributions in providing the scientific evidence that can be translated into improved clinical practice.

• This position:

• Reports to the Head of Health Policy and Systems Research, Evidence for Access (E4A) Medical Unit of US Medical Affairs (USMA).
• Will conduct research in collaboration with large, national health systems related to health care services and health care quality impacting access, delivery and outcomes. And, when appropriate, investigates potential impact(s) of GNE’s portfolio on such aspects of the health care system.
• Will be the single point of contact for systems research with large, national health systems, providing strategic oversight regarding research engagement and communication/dialogue, developing and executing health services-specific research priorities, strategies, and tactics.
• Will collaborate with therapeutic areas to inform and execute against policy and health systems research strategies.
• Works the with Head of HPSR to propose and establish cross-therapeutic area strategies, objectives, priorities, processes, budgets, metrics, and other resources needed to foster innovative, effective, and efficient execution and dissemination (e.g., peer reviewed publication) of policy and health systems research activities with large national health systems
• Works closely with external stakeholders (e.g., industry organizations, professional societies, patient advocacy organizations, health care agencies, etc.) to conduct health systems research that can inform the US access environment on behalf of GNE.
• Provides insights to E4A MU regarding US policy and health systems research findings to understand implications for GNE and further inform GNE policy-related positions and business decisions related to large national health systems
• Monitors adherence to company policies and guidelines and acts according to established procedures to ensure all issues are addressed and resolved as required.

• Key Position Responsibilities:

  RESEARCH STRATEGY and EXECUTION

• Develop robust health services research agendas with large, national health systems
• Execute research strategies and projects that include, but are not limited to, the following topic areas: access to health care (e.g., evidence-based pathways and guidelines, barriers to access, reimbursement and coverage policy), economics of health care (e.g., cost of care, financing of care, MACRA, relationship between experience, outcomes, and costs), demand for health care (e.g., aging of America, health care workforce and capacity, and population health), and the role of pharmaceuticals/biotechnologies in health care (e.g., value and indication-based pricing, pharmaceutical pricing, value-based contracting).
• Execute health services research strategies and tactics that focus on, but are not limited to, the following topic areas: delivery of health care (e.g., patient journey, information flow and exchange), efficiency of health care (e.g., care coordination, variations in care), quality and effectiveness of health care (e.g., care models, use of quality measures), and patient-centered health care (e.g., patient experience, quality of life, patient preference, patient satisfaction).
• Ensure that all research activities are strategically aligned with other functions within E4A, including E4A Molecule Research/TA research activities, and additional GNE stakeholders (e.g., Government Affairs, MCCO, etc.) as appropriate.

• EXTERNAL PARTNERING, ENGAGEMENT AND PRESENCE

• Develop relationships and collaborate with critical Thought Leaders in the transformative science and health care system research
• Lead E4A relationships with large, national health systems to shape and inform research methods and policies related to transformative science, health care services research, and health care policy topic areas.
• Leverage key external partnerships as appropriate to facilitate execution and publication of transformative science and access.
• Routinely disseminate and communicate E4A-related health services research findings externally (e.g., publications, white papers, presentations, research reports) and to Genentech senior leadership (e.g., through presentations and newsletters).
• Collaborate with internal and external stakeholders to ensure alignment with Genentech positions; maintain internal relationships with health services-related functions across Genentech.

• ORGANIZATIONAL ACCOUNTABILITY

• Act in complete & total compliance with all laws, regulations and policies.
• Establish annual and longer-range plans, goals and objectives, and effectively align these with Genentech and Roche cross-functional Research, Development and Commercial strategies and objectives.
• Develop and track metrics related to deliverables and impact of health systems research programs.
• Assume leadership role in HSPR driving and executing select initiatives.

• Qualifications - External

• Doctoral level degree in a relevant discipline (MD, PharmD, health economics, public health, health services research, epidemiology, psychology disciplines are preferred).
• 8+ years relevant healthcare industry experience that includes working successfully within a highly matrixed environment.
• 8+ years of experience in assessment of the clinical and economic value of healthcare interventions and/or systems and/or programs.
• Extensive knowledge of health economics, public health, value assessment, drug information, clinical research and development methods, decision-analytical modeling, marketing, payers, formulary processes/practices, and health services research.
• In-depth understanding of the U.S. health care system and marketplace.
• Established relationships with health service researchers/thought leaders in large US health systems
• Strong leadership skills and prior experience (6+ years) leading teams of researchers with/without direct authority.
• Previous experience in other functions within the pharmaceutical, biotechnology or related industry, e.g., research, development, medical affairs, marketing, market research, managed care, strategic planning, finance, health care consulting, etc.
• Proven track record for consistently meeting or exceeding research goals for larger-scale organizations in the pharmaceutical/biotechnology/or related industry.
• Demonstrated strategic thinking skills and ability to identify and drive creative approaches to tackle large issues and opportunities.
• Comfort and skill in working in undefined, ambiguous environments.
• Demonstrated analytical and problem-solving skills.
• Demonstrated skill in planning and execution.
• Demonstrated strong communication skills (writing, conversation, facilitation, presentation) and excellent interpersonal skills.
• Track record of high performance and results. Business travel, by air or car, is required for regular internal and external business meetings.

Key Position Responsibilities:  

• Compile and evaluate literature, synthesize and prepare evidence in various response formats intended for diverse audiences.  The response formats may include, but are not limited to, response documents, formulary dossiers, slide presentations, compendia submissions, web-based media, materials for scientific meetings, etc.
• Maintain understanding of managed care concepts and knowledge to enable customized communications (written and verbal) for organized customers and key internal stakeholders, e.g. commercial.
• Develop and maintain a sound understanding of legal and regulatory topics that underpin related policies and practices.
• Serve on internal review committees forpromotional and reactive marketing materials intended for the managed markets and payer environment as needed.  
• Train relevant internal functional partners on E4A deliverables.
• Establish and maintain understanding of the following topic areas relevant to the organized customer:  access to health care (e.g., value frameworks, evidence-based pathways and guidelines, etc.), economics of health care (e.g., cost of care, financing of care).
• Ensure that all communication activities are strategically aligned with other functions within Evidence for Access (including E4A Molecule Research/TA research activities), squads, organized customer teams, and GNE stakeholders where appropriate. 
• Develop/Assist with development of internal processes/guidance to ensure appropriate interpretation and implementation of key communication-related policies related to Evidence for Access and the organized customer (e.g., FDA Guidance on Health Care Economics Information Payer Communications).
• Assist with planning for and execution of the communication of Evidence for Access molecule, disease area, policy and health services research findings externally (e.g., publications, white papers, presentations, research reports) and to Genentech senior leadership (e.g., through presentations and newsletters).
• Maintain awareness of Genentech policy positions and ensure communications and outputs are in alignment with these positions.  
• Act in complete & total compliance with all laws, regulations and policies.

Requirements:

• Masters or Doctoral level degree, in a relevant discipline (MD, PharmD, health economics, public health, public policy, health services research disciplines are preferred).
• 1 – 5 years of clinical pharmacy or equivalent experience
• 1 – 5 years of prior industry experience, including managed care experience, that includes working successfully within a highly matrixed environment
• 3 or more years of medical writing experience
• Extensive knowledge of health economics, public health, value assessment, drug information, clinical research and development methods, decision-analytical modeling, marketing, payers, formulary processes/practices, and health services research.  
• In-depth understanding of the U.S. health care system and marketplace.
• Strong skills/experience working in a matrix environment and leading without authority.
• Previous experience in other functions within the pharmaceutical, biotechnology or related industry is a plus, e.g., research, development, medical affairs, marketing, market research, managed care, strategic planning, health care consulting, etc.
• Proven ability to critically evaluate and synthesize data and information from multiple sources.
• Strong and effective written and verbal communication skills, including meeting facilitation and presentation capabilities.  
• Must demonstrate a high level of technical proficiency and aptitude for common communication tools and platforms – MS Word, Excel, PowerPoint, etc.
• Excellent interpersonal skills:  works well within teams and can effectively and quickly establish rapport with all key internal/external customers, partners, and other stakeholders.
• Demonstrated strategic thinking skills and ability to identify and drive creative approaches in communicating information to the organized customer.
• Comfort and skill in working in undefined, ambiguous environments.
• Demonstrated analytical and problem-solving skills.
• Demonstrated skill in planning and execution. 
• Track record of high performance and results.
• Business travel, by air or car, is required for regular internal and external business meetings.

Key Position Responsibilities:  

• Compile and evaluate literature, synthesize and prepare evidence in various response formats intended for diverse audiences.  The response formats may include, but are not limited to, response documents, formulary dossiers, slide presentations, compendia submissions, web-based media, materials for scientific meetings, etc.
• Maintain understanding of managed care concepts and knowledge to enable customized communications (written and verbal) for organized customers and key internal stakeholders, e.g. commercial.
• Develop and maintain a sound understanding of legal and regulatory topics that underpin related policies and practices.

Serve on internal review committees for promotional and reactive marketing materials intended for the managed markets and payer environment as needed. 

• Train relevant internal functional partners on E4A deliverables.
• Establish and maintain understanding of the following topic areas relevant to the organized customer:  access to health care (e.g., value frameworks, evidence-based pathways and guidelines, etc.), economics of health care (e.g., cost of care, financing of care).
• Ensure that all communication activities are strategically aligned with other functions within Evidence for Access (including E4A Molecule Research/TA research activities), squads, organized customer teams, and GNE stakeholders where appropriate.
• Develop/Assist with development of internal processes/guidance to ensure appropriate interpretation and implementation of key communication-related policies related to Evidence for Access and the organized customer (e.g., FDA Guidance on Health Care Economics Information Payer Communications).
• Assist with planning for and execution of the communication of Evidence for Access molecule, disease area, policy and health services research findings externally (e.g., publications, white papers, presentations, research reports) and to Genentech senior leadership (e.g., through presentations and newsletters).
• Maintain awareness of Genentech policy positions and ensure communications and outputs are in alignment with these positions. 
• Act in complete & total compliance with all laws, regulations and policies.

Requirements:

• Masters or Doctoral level degree, in a relevant discipline (MD, PharmD, health economics, public health, public policy, health services research disciplines are preferred).
• 1 – 5 years of clinical pharmacy or equivalent experience
• 1 – 5 years of prior industry experience, including managed care experience, that includes working successfully within a highly matrixed environment
• 3 or more years of medical writing experience
• Extensive knowledge of health economics, public health, value assessment, drug information, clinical research and development methods, decision-analytical modeling, marketing, payers, formulary processes/practices, and health services research. 
• In-depth understanding of the U.S. health care system and marketplace.
• Strong skills/experience working in a matrix environment and leading without authority.
• Previous experience in other functions within the pharmaceutical, biotechnology or related industry is a plus, e.g., research, development, medical affairs, marketing, market research, managed care, strategic planning, health care consulting, etc.
• Proven ability to critically evaluate and synthesize data and information from multiple sources.

• Strong and effective written and verbal communication skills, including meeting facilitation and presentation capabilities. 
• Must demonstrate a high level of technical proficiency and aptitude for common communication tools and platforms – MS Word, Excel, PowerPoint, etc.
• Excellent interpersonal skills:  works well within teams and can effectively and quickly establish rapport with all key internal/external customers, partners, and other stakeholders.
• Demonstrated strategic thinking skills and ability to identify and drive creative approaches in communicating information to the organized customer.
• Comfort and skill in working in undefined, ambiguous environments.
• Demonstrated analytical and problem-solving skills.
• Demonstrated skill in planning and execution.
• Track record of high performance and results.
• Business travel, by air or car, is required for regular internal and external business meetings.

Position Summary:

• You will collaborate with cross-functional teams to develop real world evidence strategies and tactics to support medical teams and access to appropriate therapeutic options.
• You will work closely with internal stakeholders from across the company, including others in Medical Affairs, Government Affairs, Managed Care & Customer Operations, Commercial and Product Development, as well as key external stakeholders, including but not limited to, academics, healthcare providers, payers, and professional societies. 
• All Roche employees are expected to effectively contribute to cross-functional collaboration and coordination and comply with all laws, regulations, policies & procedures that govern our business. 

Responsibilities Include:

• Developing and maintaining an in-depth understanding of therapeutic area strategies, disease areas, relevant clinical, patient, payer, and reimbursement landscapes.
• Develop, maintain and apply in-depth knowledge of role, disease state and clinical topics, market/ customer landscape, and emerging policy issues.
• Developing comprehensive evidence generation strategies including health economic and outcomes research (HEOR) as well as health systems’ research to support the value demonstration of assets pre-launch and/or marketed products in relevant disease/ therapeutic areas.
• Expertly demonstrating to payers, clinicians, patients and other external constituents the health economic, humanistic, and health systems’ value and benefit of Genentech's products.
• Develop robust real-world evidence generation strategies and flawlessly execute studies (e.g., burden of illness studies, treatment patterns, quality of care etc.). 
• Expertly designing, developing, conducting, overseeing and/or managing primary and secondary non-interventional studies and HEOR models and appropriate field communication and tools to support access decisions
• Assist in development of robust, targeted and efficient HEOR modeling and other key processes, standards, techniques and tools
• Identify opportunities to partner with external customers to conduct E4A projects in support of asset and therapeutic area strategies.
• Develop strategic partnerships and research collaborations with key external experts, healthcare policy makers, payers and various academic and community settings to support asset strategies.
• Work independently with minimal guidance, with direction and mentoring from manager and others to clarify directions and expand knowledge and skills. Proactively collaborate with various functions within and outside of Evidence for Access and US Medical Affairs to ensure alignment of activities with key partners and stakeholders.
• Lead and/or participate in E4A and cross-functional projects.
• Manage budgets, timelines and deliverables as planned.
• Attend customer and other external meetings to advance learning, build relationships and demonstrate Genentech’s value.
• Participate in all required Genentech and E4A training and development programs. Comply with all internal policies and external regulations.
• When assigned, playing a lead role, representing E4A, in cross-functional long-range strategies and/or other programs that influence or otherwise impact quality of life, appropriate access and/or other HEOR/Health Systems dynamics
• When assigned, playing a lead role, representing E4A as a standing or ad hoc member/participant in Genentech and/or global Roche core and sub teams Developing and cultivating relationships with therapy area leaders (TALs) and other thought leaders
• Assisting with recruitment, ongoing coaching/mentoring, and training of new or less experienced health economists/health services researchers
• Ensuring assigned goals and objectives are met and that assigned projects and other work are completed on time, to high standards and within budget
• Working collaboratively and efficiently with all internal and external customers, partners and stakeholders 

Abilities:

• Demonstrate strong leadership and communication skills: can effectively communicate through a variety of means and contribute to the development of vision and strategy in Medical Affairs teams.
• Demonstrated abilities to manage complex projects and multiple priorities.
• Strong orientation to teamwork: works collaboratively, effectively and efficiently with others in a matrixed team environment

• Lead the development of the HEOR strategies to support the value of assets pre-launch and/or marketed products in the relevant disease areas.
• Lead the execution of HEOR studies and projects (including pharmacoeconomic models, Non-Interventional Studies etc.) to demonstrate the value proposition for assets in relevant disease areas.
• Develop real-world evidence generation strategies and flawlessly execute studies (e.g., burden of illness studies, epidemiology studies etc.).
• Identify opportunities to partner with external customers to conduct HEOR projects in support of asset and therapeutic area strategies.
• Develop strategic partnerships and research collaborations with key external experts, healthcare policy makers, payers and various academic and community settings to support asset strategies.
• Design, develop, conduct and manage HEOR studies for assigned product(s) and indications(s).
• Develop, maintain and apply in-depth knowledge of role, disease state and clinical topics, market/customer landscape and emerging issues.
• Work independently with minimal guidance, with direction and mentoring from manager and others to clarify directions and expand knowledge and skills.
• Proactively collaborate with various functions within and outside of US Medical Affairs to ensure alignment of activities with key partners and stakeholders.
• Lead and/or participate in HEOR and cross-functional projects.
• Manage budgets, timelines and deliverables as planned.
• Lead and/or participate in HEOR and cross-functional projects.
• Attend customer and other external meetings to advance learning, build relationships and demonstrate Genentech’s value.
• Participate in all required Genentech and HEOR training and development programs.
• Comply with all internal policies and external regulations.

Abilities:

• Demonstrate strong leadership and communication skills: can effectively communicate through a variety of means and contribute to the development of vision and strategy in Medical Affairs teams.
• Demonstrate abilities to manage complex projects and multiple priorities.
• Strong orientation to teamwork: works collaboratively, effectively and efficiently with others in a matrixed team environment.

Requirements:

• Masters Degree (health economics, epidemiology, life sciences, public health, health services research); Doctoral Degree in above or other related disciplines is preferred.
• Two years’ of experience in relevant health economics and outcomes research fields, one of which are part of a health economics and/or outcomes research team in a pharmaceutical company.
• In-depth knowledge of biometrics, biostatistics, clinical research and development methods, epidemiology, decision analytical modeling, marketing, payers and formulary processes/practices. In –depth understanding of the U.S., healthcare landscape.
• In-depth knowledge of relevant health economics strategy development, HEOR methodologies and modeling (quantitative and qualitative).
• Strong working knowledge of the technical and methodological aspects of observational study design and implementation. Capable of independently managing non-interventional study projects.
• Strong methodological skills (pharmacoeconomic modeling, study design, data analysis and interpretation) in epidemiology or health services research is required.
• Excellent interpersonal skills required: ability to understand and respond to multiple internal and external customers.
• Excellent written and oral communication skills required.
• Strong project management abilities (contracting, budgeting, vendor management) essential.
• Demonstrated ability to manage multiple projects (multitask) involving complex processes, competing deadlines and rapidly shifting priorities.
• Demonstrated effectiveness working with teams and leading teams.
• Knowledge of the overall drug development, medical affairs, and post-marketing planning relevant to pharmaceutical/biotechnology organizations.
• Ability to influence key members of medical and commercial teams constructively and without conflict.
• Skilled in functioning within a matrix organization where managing through influence is required.
• Business travel, by air or car, is required for regular internal and external business meetings.

Genentech’s South San Francisco manufacturing facility has an opportunity available in the Process Engineering group supporting cGMP manufacturing of both clinical and commercial products. The group is responsible for monitoring, troubleshooting, and improving upstream and downstream unit operations from seed train through bulk formulation, and providing scientific and technical judgment as part of a team responsible for delivering high quality biopharmaceutical products to patients.   Integrity, accountability, and strong dedication to the patients we serve are critical to this role.  

Responsibilities of this position include:

• Adhere to all applicable compliance and safety requirements, cGMPs, SOPs, and other manufacturing documents
• Provide manufacturing floor technical support
• Monitor and analyze manufacturing data as necessary to provide support for process discrepancies, investigations, validation protocols, process transfers, or equipment troubleshooting
• Analyze data and execute experiments aimed at improving process robustness/productivity or meeting the changing needs of the manufacturing environment
• Implement engineering projects of various magnitude in order to increase levels of safety and/or compliance, improve process and equipment robustness, or increase capacity/productivity/efficiency.
• Support product impact and root cause assessments for process discrepancies and Quality investigations
• Support of regulatory inspections and filings
• Create / revise standard operating procedures and manufacturing tickets
• Provide training and technical mentorship for manufacturing operators
• Lead cross-functional technical teams on large scale improvement and compliance related initiatives

We are seeking applicants who possess the following minimum qualifications. The position can be filled at a more senior level depending on the qualifications of the selected candidate.

• Bachelor’s degree in Engineering, Science, or related discipline
• 2+ years of relevant experience in industry or academia (including advanced studies) post Bachelor’s degree
• Experience working in a cGMP environment
• Experience with cell culture and/or purification process science/development strongly preferred
• Knowledge of safety principles, quality systems, and cGMP
• Knowledge of large scale biopharmaceutical manufacturing processes and equipment
• Relevant work experience in a lab, pilot plant, manufacturing, or manufacturing support setting
• Highly motivated and proactive with a track record of taking initiative to achieve business results
• Demonstrated strong problem solving capabilities
• Able to work independently and as part of a team
• Strong oral and written communication skills
• Excellent organization skills

As with any position in a manufacturing environment, the job requires an ability to adapt to rapidly changing priorities and the flexibility to support operations in accordance with the manufacturing schedule. Requires the ability to routinely access and work for extended periods of time in a cGMP facility, including adherence to all gowning and safety procedures.

#LI-PTD-JM

 As Category Manager Biomarker, you are part of Roche Global Procurement, and you will be working on developing and executing Global Category Strategies as part of the Global R&D Category team.

Global Procurement (GP) is a key function that delivers value to Roche by leveraging market knowledge, subject matter expertise and business insights in the procurement of goods and services and the management of Roche’s third party spend. Through collaboration with our external suppliers and internal business partners, GP helps bring innovative tests and medicines to patients.

As the Category Manager Biomarker, you are responsible for developing Biomarker Category Strategy/Strategies and executing a pipeline of high value strategic initiatives on a global basis. Based on your deep subject matter expertise in the area of Biomarker (focus area includes Bioanalytical assays, Soluble Biomarkers, and Flow cytometry), you are proactively identifying opportunities, engaging, and partnering with senior Business stakeholders and regional Procurement, and managing suppliers to deliver the overall Category performance and savings targets.

Thanks to your strong leadership, communication, and influencing skills, you ensure stakeholder alignment and support to deliver value through the implementation of Category Strategies and initiatives. You further establish effective working relationships with local and regional procurement to ensure alignment and the full realization of the benefits of the Category Strategy.

Your responsibilities:

• Accountable for the creation and application of a Business-aligned long-term Biomarker Category Strategy and the development of an annual pipeline of strategic category initiatives.
• Executing Category initiatives and ensure responsibility for the delivery and reporting of savings targets.
• Providing strategic input to the development of the Biomarker Category Buying Guide to translate the Category Strategy and Annual Plan into clear, practical guidance for key Procurement and functional colleagues.
• Understanding business priorities and challenges and ensuring successful realization of the Category Strategy by building strong partnerships across geographically dispersed stakeholders and engaging with local and regional Procurement.
• Ensuring a robust approach to supplier management, establishing value creation targets and reporting of supplier performance, developing innovation programs, managing supplier risks and conducting regular business reviews.

This position is not eligible for relocation.

Your qualifications:

• University degree, with business or life sciences degree preferable.
• 7+ years in-depth strategic and/or operational procurement experience with extensive knowledge of category management and advanced strategic sourcing, with subject matter expertise in Biomarker and Lab sciences categories.
• Excellent communication and project management skills with an ability to lead and coordinate cross-functional teams and deliver complex strategic initiatives, in a truly global, fluid, interactive environment.
• Proven financial and business acumen and capability in negotiation, change management and stakeholder management.
• Business level fluency in English.

*LI-CG-LN

The South San Francisco Quality group has and opportunity available for a skilled Technical Manager. The purpose of the role is to:

• Provide Quality oversight to internal and external customers.

• Provide input as a Subject Matter Expert into investigations with potential product, process, or material impact.

• Create and maintain a system for tracking, trending, and reporting discrepancies.

• Monitor QA activities to evaluate trends, and report repetitive anomalies, observations, and present discrepancies to Senior Management.  

• Represent QA at cross-functional meetings to develop, review, and approve documents.

• Support the creation, maintenance and review of Risk Management documents.

• Ensure proper department policies and procedures are in place to execute QA functions.

Accountabilities

• Develop solutions to complex Deviations, local and Global Investigations, and Quality initiatives with inter-organizational impact following cGMP regulations and Genentech standards 
• Inform management of quality discrepancies and provide timely impact assessments of potentially affected products, materials or processes.
• Ensure investigation action plans and final investigation summaries are accurate, include appropriate corrective actions, and follow company standards.
• Identify and ensure investigation reports are reviewed and approved by appropriate levels of Management.
• Review and approve investigation reports and supporting documentation.
• Lead collaboration with departments to establish appropriate, efficient, and timely investigation strategies.
• Provide final product disposition recommendations that may be affected by investigations to Senior Management.
• Educate departments and the network on the best practices for conducting investigations, root cause analysis, and CAPA creation.
• Collaborate with CAPA Owners to manage CAPAs in the Trackwise system to ensure they are well planned, effective, and completed in a timely manner.
• Own department/group/global CAPAs to achieve company goals, department objectives, and quality issues.
• Assess the accuracy of root cause determinations based on a thorough evaluation of possible failure modes.

General Job Duties/Responsibilities

• Set personal performance goals and provide input to departmental objectives.
• Establish work priorities to meet targets and timelines.
• Serve as the Quality representative on cross-functional and multi-site teams.
• Identify, design, and implement process and system improvements for the network.
• Manage department and cross-functional initiatives.
• Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.
• Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
• Serve as a technical subject matter expert (SME) in support of department functions.
• Develop and train personnel, internal and external customers on relevant business processes.
• Mentor junior personnel serving as a subject matter expert (SME) on Quality systems, processes and issues.
• Collaborate and author department policies and procedures.
• Make decisions that impact the goals and objectives of the department.
• Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.

Qualifications

The right candidate will posess the following skills and experience:

• Bachelor's degree, preferably in Life Science
• 8+ years of relevant technical operations experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of advanced education and relevant experience; 10+ years required for the Principal level
• Strong technical background with sound knowledge of cGMP regulations
• Experience addressing critical Quality issues with the ability to interpret and relate Quality standards for implementation and review
• Ability to make sound decisions about scheduling, allocation of resources, and managing priorities
• Ability to communicate clearly and professionally both in writing and verbally
• Team leadership capabilities
• Strong problem solving and critical thinking skills
• Ability to work independently and deliver results under tight deadlines

The Position

In the BioAnalytical Sciences (BAS) Department at Genentech, we are a world-class bioanalytical center of excellence for novel strategies, technologies, and methods that enable the development of life-changing medicines. We do this by fostering an innovative and collaborative environment that values and recognizes diversity of contributions. 

The BAS-ADT department is seeking a highly motivated creative Associate Scientist with hands-on experience developing, evaluating and implementing state of the art quantitative bioanalytical methods to support biopharmaceuticals in the Genentech Immunology and Neurology pipeline.

Responsibilities for this position include development, characterization, and qualification of in vitroassay methods to quantify biotherapeutic levels in various species andbiological matrices, to detect and characterize immuneresponses evokedby the biotherapeutic, and to measure biomarkers.  This willinvolve manual laboratorywork, the useof automation systems and use of various assay platforms, including ELISA, Quanterix, Ella, Gyros, Singulex and Luminex. This individual is also involved in the technical transfer of assays to CROs for assay validation as well as for the technical oversight of sample analysis from nonclinical and clinical studies. This individual may also be involved in non-GLP sample analysis and data reporting. Associate Scientists in ADT are expected to contribute to departmentalactivities and participate in compliance and safety related activities. They may also be expected to help traincolleagues.

This Associate Scientist will work in a fast-paced environment and represent BAS on multiple projects and cross-functional teams from early development through clinical studies to support projects and prepare technicaldocumentsfor internal distribution or inclusion in regulatory filings. The successful candidate is also expected publish novel findings related to the job responsibilities.

Who you are

In hiring new employees, we look for people who are also inspired by our mission and who would fit in well with the collaborative, rigorous and entrepreneurial spirit of the company culture. Because we know that employees are critical to our success in bringing novel medicines to patients, we are dedicated to remaining a great place to work and to providing employees with programs, services and benefits that allow them to bring the best to the business and to their personal lives.

A Ph.D. in Immunology, Biochemistry, or a related scientific discipline with postgraduate experienceis preferred.  Hands-on experience in developing quantitative analyte,anti-therapeutic antibody and/or biomarker assaysfor proteintherapeutics, alongwith a proven track record of publications solving complex bioanalyticalproblems are required.  The work will require the application of state-of-the-art technologies, including desirable knowledge of Quanterix, Ella, Singulex, Gyros and Luminex.Pharmaceutical or biotechnology industry experience is an advantage. Experience in Immunology and Neurology is a plus. Managerial experience is a plus. Excellent communication, interpersonal and organizational skills are essential. 

Key ResponsibilitiesGeneral management

• Lead budget management, resource allocation, strategic planning to maximize value delivery by the Oncology regulatory function
• Own functional KPI framework to measure success and continuous improvement of the function
• Ensure excellence in management of people, finance and communications by partnering with the relevant business partners