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Date Job Title Job Level Location
7/21/17 Tecan System Specialist/In Vitro ADME Scientific Researcher Individual Contributor South San Francisco, California

Drug Metabolism and Pharmacokinetics (DMPK)
The DMPK group is dedicated to enabling the discovery, development and commercialization of safe and effective medicines by elucidating the absorption, distribution, metabolism, excretion and pharmacokinetic properties of small molecule drug candidates. We accomplish this through the application of state of the art technologies and sciences of bioanalysis, drug metabolism, drug transport and pharmacokinetics. The DMPK group works in close partnership with disciplines such as medicinal chemistry, pharmacology, toxicology, pharmaceutical sciences, clinical pharmacology and regulatory to optimize leads, select clinical candidates, conduct preclinical development studies, support clinical evaluation and contribute to IND and NDA filings.

We are seeking an in vitro ADME automation specialist with a proven track record of assay development and automation to join the Small Molecule DMPK Department and support different automation platforms including Tecan, Agilent, Oasis and Hamilton systems. The successful candidate will work closely with our established team, support multiple existing in vitro ADME assays and provide real-time troubleshooting. Hands-on experience in LC-MS/MS and in vitro ADME assays is also highly desirable.

Responsibilities include:

  • Configure, program and troubleshoot laboratory automation platforms to support in vitro ADME assays including CYP inhibition, metabolic stability and protein binding assays.
  • Schedule and coordinate routine and non-routine maintenance and repairs, maintain inventory of parts, and coordinate service with outside vendors. 
  • Investigate and recommend new laboratory automation platforms supporting existing and new assays. Responsible for laboratory instrument acquisition and installation.
  • Conduct, automate and validate new in vitro ADME assays to support small molecule drug discovery and development.
  • Support data analysis, processing and reporting using various tools including excel, graphpad prism, ELN and other custom software. 
  • Continuously work to improve quality and efficiency of assay automation.

7/21/17 Program Director/Associate Program Director, Regulatory Program Management Individual Contributor South San Francisco, California

GENERAL POSITION SUMMARY/PURPOSE:
Regulatory Program Management is part of the broader PDR organization that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for Roche’s global Pharma Medicines Division, which includes all therapeutic areas and all phases of product development from early development to post-marketing. PDR is responsible for the timely submission of applications to health authorities for approval of new products and line extensions. PDR is committed to regulatory strategies that are the most innovative, ethical, and influential in the industry. Like others in Regulatory Program Management, Program Directors are assigned their responsibilities by therapeutic area, and are assigned projects for different product development phases, as business needs dictate. Regulatory Program Management Associate Program Directors provide regulatory leadership for one or more regional development projects. Regulatory Program Management Associate Program Directors are responsible for the development and implementation of regulatory strategies to facilitate the development and approval of Roche medicines for human use. Regulatory Program Management Associate Program Directors are expected to lead their assigned projects and represent PDR to cross-functional teams and groups with supervision. Regulatory Program Management Associate Program Directors are responsible for working cross-functionally and coordinating regulatory-related activities across PDR functions and with other internal partners. Regulatory Program Management Associate Program Directors serve as the principal interface with primary reviewers from health authorities and for other interactions with relevant regulatory-related external parties; managing the strategies for and execution of these interactions.

JOB DESCRIPTION – PRIMARY DUTIES AND RESPONSIBILITIES:

1. Intact & Cross-Functional Teams

  • Participates in site, regional and/or global PDR Program Management departmental meetings
  • Participates as a standing member in various teams, dependent upon assigned projects and the associated development phase, such as early development core teams, global development teams and lifecycle teams. Represents PDR in such capacities and coordinates cross-functional PDR contributions to product development projects and other related activities
  • Leads the Regulatory Affairs Functional Team (RAFT) for assigned product development projects to ensure effective and efficient cross-functional PDR coordination, appropriate resources, and timely, thorough and compliant execution
  • As assigned, may act as a standing or ad hoc member of other teams for special or ongoing initiatives and projects
2. Regulatory Program Management
  • Stays abreast of internal and external developments, trends and other dynamics relevant to the work of PD and PDR to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for assigned therapeutic areas and projects. Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics. Briefs teams and management, as appropriate
  • Obtains and applies in-depth knowledge of Roche and regulatory guidelines, procedures and best practices
  • Provides regulatory expertise and leadership to site and regional cross-functional teams and other groups
  • Stays abreast of therapeutic area product development and other related business strategies and plans
  • Serves as the primary PDR representative on one or more regional projects at any one point in time
  • Analyzes data, the regulatory environment and business objectives to recommend priorities
  • Leads teams in developing, implementing and delivering the cross-functional regulatory strategy for each project or related assignment. Plays a lead role in helping ensure effective balance of time, cost, quality and risk so that regulatory strategies meet the needs of patients, prescribers, payers, regulators and Roche 
  • Plays a key role in assuring business objectives are understood and taken into account during regulatory strategy development
  • Identifies and aligns cross-functional regulatory resources necessary to execute the regulatory strategy for each project or related assignment
  • Works with others to ensure timely and appropriate cross-functional alignment and appointment to RAFT for each assigned project
  • Presents and obtains approvals for the cross-functional regulatory strategy to various teams, committees and senior management
  • Serves as the site and/or regional principal interface with primary reviewers from regulatory authorities or for other regulatory-related interactions with other external parties. Establishes effective working relationships with regulatory authorities and directs regulatory interactions for internal site and/or regional teams
  • Provides internal teams with direction on regulatory authority interactions
  • Manages ongoing RAFT meetings. Including providing ongoing leadership of regulatory deliverables and guidance on compliance, timing and other relevant matters. Manages RAFT resources
  • Ensures cross-functional perspectives and expertise are incorporated into regulatory plans prior to decisions being made
  • Manages decision-making and conflict resolution surrounding regulatory issues within cross-functional teams, including coordination between other business teams and RAFT team. Ensures appropriate escalation to team leaders or functional management, as necessary
  • Oversees, coordinates and provides a first-line of internal approvals for regulatory submissions and other relevant regulatory documentation
  • Responsible to ensure all PDR deliverables associated with each project or other assignment are completed within defined timelines and meet regulatory and other company guidelines
  • Develops regulatory risk management and contingency plans. Communicates plans to management, as appropriate
  • Works with other functions and functional management to ensure the relevant regulatory team has appropriate budget and resources to meet objectives. Manages or co-manages relevant project budgets to ensure compliance with agreed parameters and provides routine and ad hoc budget reporting and other updates
  • As relevant, provides day-to-day guidance and direction to less experienced Regulatory Program Management staff and their work supporting the same projects or other assignments
  • Provides and receives direct and objective performance feedback on/from cross-functional team members
  • As requested or otherwise appropriate, provides regulatory due diligence assessments in cooperation with other internal groups
3. Other
  • As assigned, trains, coaches and mentors new or less experienced Regulatory Program Management staff members
  • Participates in and/or otherwise supports development and implementation of new or updated PDR and/or Regulatory Program Management-specific systems, processes, Standard/Department Operating Procedures (SOPs/DOPs) or other relevant tools
  • Completes other routine and ad hoc analysis and reporting. Responsible to keep all internal customers, partners and stakeholders abreast of progress and interim updates. Does so by following prescribed departmental procedures, practices and protocols and by using standardized reporting and communications tools/templates and other resources
  • Participates in and/or otherwise leads other special projects, as and when assigned, or otherwise requested
  • Participates in routine and ad hoc departmental meetings and other business reviews or meetings to remain, at all times, fully abreast and apprised of evolving internal and external needs and requirements. Expected to share best practices within the department and cross-functionally, identify and communicate opportunities for departmental enhancements and efficiencies
  • Consistently complies with all governing laws, regulations, Roche SOPs and other guidelines


7/21/17 Incentive Compensation Policy Manager Individual Contributor South San Francisco, California

Job Overview:
This role is responsible to determining, authoring and maintaining GNE’s Incentive Compensation Policy, SOPs and associated knowledge management materials. It is a vital role, one that drives organizational clarity, operational alignment and keeps our incentive compensation program safe – fueling our vision to lead an IC Program that is the strategic lever that drives field performance. The ideal candidate will have a mixture of leadership skills combined with detail orientation and an appreciation for clear and unambiguous messaging and documentation. Various backgrounds can be successful in this role, including those with direct incentive compensation experience, HR experience and / or a legal background. Critical competencies include teamwork and collaboration, strategic agility, communication, and managing change. The key leadership commitments include explaining the why and simplifying work.

This role is a key hub that connects and aligns our broader FAO organization in the activities that drive our incentive compensation program and our partnership with all levels of field sales stakeholders. Functionally, this role would monitor existing IC policy, guidelines, SOPs and associated materials, determine when business needs are changing and updates are required and see that process through. This role would also identify new and emerging areas where SOPs and policy are required. In support of our IC Policy, this role would also maintain our portfolio IC knowledge management tools – ensuring complete, up to date and appropriate content while also integrating these resources into our various CBO and field training training and communication channels. This role would also support questions, clarifications and exception requests to policy, guidelines and SOPs from both CBO and field stakeholders. All of these activities would be performed in strong collaboration with SCGA, FAO, legal, compliance, HR and our field stakeholders.

Key Responsibilities

  • Author, maintain and refine our Incentive Compensation Policy and Guidelines
  • Author, maintain and refine our Incentive Compensation compliance driven Standard Operating Procedures
  • Maintain and enhance our Incentive Compensation Knowledge Management portals and resources
  • Drive change and clarity throughout Commercial on our IC Policy, Guidelines and SOPs
  • Ensure inclusion of Incentive Compensation materials in FAO, CBO and Field Training. Conduct internal trainings – both formal and informal.
  • Triage and respond to policy inquiries and exception requests
  • Collaborate and assist broader Incentive Compensation team with solving problems, enhancing our IC program, and innovation.
  • Assist SCGA team members during peak work times.
  • Present and engage in discussions regarding IC Policy with senior leadership (quarterly opportunity to review with CBO VP, annual opportunity with CEO, monthly opportunity to attend NSD Council and FOM Forums).
  • Critical competencies include:
    • teamwork and collaboration
    • strategic agility
    • communication
    • managing change
7/21/17 Clinical Safety Associate Individual Contributor South San Francisco, California

The Clinical Safety Associate I (CSA I) supports the drug safety staff in the day to day 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 CSA I supports study management activities in collaboration with other functional groups and supports the US Drug Safety Case Management Manager (CMM) in all activities. All responsibilities are performed under the direction of the CMM. 


Key Accountabilities:
  • Completes drug safety monitoring and tracking in a timely, thorough and accurate manner in accordance with pharmacovigilance (PV) and related standards, regulations and Genentech/Roche Standard Operating Procedures (SOPs) (~60% and as per business needs)
    • Reviews, evaluates and verifies potential AE information to determine required action per internal policies and procedures
    • Provides medical assessment on all cases for seriousness / validity / causality and conducts quality review of all cases (as applicable) including medical review of information entered in the safety database for completeness and coherency 
    • Performs follow up (e.g. Drug specific questionnaires / Pregnancy reports etc.) for all reported cases (as applicable) based on their assessment (i.e. Medically significant, non-serious, invalid etc.) to capture complete medical picture of an ICSR
    • Medically reviews ancillary documentation accompanying Individual Case Safety Reports (ICSRs) and identifies medically relevant safety information for incorporation into the Global Safety Database
    • Demonstrates understanding of appropriate labeling documents for Genentech/ Roche molecules and products and performs labelling assessment for AE(s) received using clinical knowledge
    • Identifies and collaborate with external stakeholders for Antibody testing requests Responsible for identifying ICSRs requiring expedited safety reporting to Health Authorities. (~5%)
  • Responsible for review and implementation of internal Manuals, global / local safety SOPs / Work Instructions (applicable to USDS). Identify the need for creating additional or updating existing local Guidance Documents including but not limited to training matrix and identify appropriate target audience for training assignment. (~3%)
  • Demonstrates a general understanding of protocol management in accordance with PV related standards, regulations and Genentech/Roche Standard Operating Procedures (SOPs) to support the protocol review process for supported/funded studies (~10%)
    • Perform Post Authorization Safety Assessment (PASS) classification for all Genentech /Roche supported studies based on medical knowledge and European Union (EU) regulations
    • Assists in reviewing Safety Data Exchange Agreements (as applicable) Participates and supports the Supported Research Team (as applicable)
    • Assists in AE reconciliation and/or Case Transmission Verification (CTV) activities (as applicable)
    • Acts as single point of contact for safety related issues
    • Acts as Safety Liaison between Safety Science and Supported Research Team Oversees Safety related activities for assigned Genentech/ Roche Product(s) managed by US Medical Affairs to include (~10%)
    • Demonstrates advanced knowledge of the safety profile to include comprehensive working knowledge of appropriate labeling documents for assigned Genentech/ Roche Product(s) 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, Supported Research Teams (SRT) and Medical Team
    • Responsible for medical review and updating of safety sections for documents e.g. pregnancy letters and notify appropriate stakeholders of any changes in executive summary of aggregate reports
    • Assist in implementation of Risk Management Plans (RMP) / Risk Minimization activities or Risk Evaluation and Mitigation Strategies (REMS) for assigned molecules / products
  • Assists in projects under the direction of US Drug Safety management or project lead (~10%)
  • Contribute to the preparation and development of Drug Safety presentations for internal/external stakeholders as applicable (~2%)
  • Liaise with Compliance and Training (CAT) / Business Operations Analytics and Market Research and Patient Support (BAM) teams within USDS to ensure all processes are implemented
  • Supports the onboarding and training of new personnel
  • Provides support during audits and inspections
  • Acts as Subject Matter Expert (SME) for safety related activities within Global Safety Database per Genentech/Roche SOPs 

Competencies Identified for Success:
  • Demonstrates capability to comprehend medical information
  • Works effectively, independently and collaboratively
  • Strong organizational skills, detail oriented and adapts in a fast paced, changing environment
  • Demonstrates ownership, initiative and accountability
  • Excellent communication skills, both written and verbal
  • Ability to prioritize tasks in a timely manner
  • Ability to interact effectively in a multifunctional, multidisciplinary team setting
7/21/17 QA Specialist II/III, Quality Compliance Individual Contributor Hillsboro, Oregon

*** Please note this position is being re-posted to reflect that there are now two positions.  The position can be either a QA Specialist II or III ***


 JobResponsibilities:

  • Develop and execute inspection/audit prep plans and manage the inspection readiness activities (maintain key contact list, prep/strategy sessions, inspection readiness training, etc.)
    • Manage and maintain the lnspection Ready Room
    • Conduct post-inspection lessons learned sessions
    • Participate in cross site Inspection Readiness meetings
  • Manage and facilitate internal audits/assessments, partner audits and regulatory inspections for the site
    • Manage and provide oversight on the response process for audits and inspections
    • Track inspection commitments to completion
    • Perform post inspection impact assessment of findings identified from other GNE sites
  • Manage and provide oversight on the site self-inspection program
  • Manage the process for identifying and assessing compliance risks and track remediation  activities/ action plans to closure
    • Conduct training for the Compliance Scoring Tool and Process
    • Maintain the site inspection risk log and publish the Inspection Readiness scorecard in accordance to the defined global schedule
  • Provide inputs to standard Quality reports, such as summaries for Annual Product Reviews
  • Support creation and maintenance of documents supporting Regulatory filings, such as Site Master Files, Regulatory Maps
  • Serve as the Quality representative on cross-functional and multi-site teams
  • Train new personnel and internal customers on relevant business processes.
  • Interact with senior internal and external personnel on significant matters.
  • Represent organization as a prime contact on initiatives and projects.
  • Interface with supplier quality management team to ensure supplier compliance with cGMPS and applicable regulations
  • Maintain Quality Agreementsin close collaboration with SMEs, Contract Management group and businesspartners Quality and Service Level Agreements.
7/21/17 Automation Engineer / Sr. Automation Engineer, Protein Sciences Individual Contributor South San Francisco, California

We are looking for an automation engineer to design and automate a platform for high throughput DNA, RNA and protein production, purification and archiving. The motivated candidate will control a range of automated laboratory robotic systems and will be in charge of designing, programing and simulating the system. The role will include troubleshooting and tech support for the multiple tools and will involve liaising with vendors. A successful candidate will initiate improvements and development to promote efficiency of the overall automated system and the individual tools. Key responsibilities:

? Configure, program and troubleshoot various laboratory automation platforms

? Identify process improvement opportunities, establish solutions and implement changes

? Investigate and recommend new laboratory automation platforms and upgrades to existing tools, while assessing risk and impact to maintenance data or activities

? Participate in project teams to help identify requirements for new functionalities and perform impact analysis

? Monitor equipment, product and system performance to ensure operational quality, and report issues

? Serve as the liaison with the vendors for a complete product conversion installation, upgrades or patches and support as required

? Participate in the development of internal software solutions to meet high throughput goals

? Produce high quality end user documentation and system/internal documentation

? Conduct on-site user training in different levels

? Perform thorough regression testing when bugs are resolved

7/21/17 Senior/Medical Science Liaison, Breast, GI, GYN Oncology- Northeast territory (NY incl. Long Island) Individual Contributor New York

Key Accountabilities 


In this position, you will be primarily accountable for effectively:

  • Representing the assigned molecules/products, franchise(s) and overall therapeutic area(s) to the highest ethical and professional standards and in accordance with guidelines and direction.
  • Responding to on and off-label questions with integrity, compliance, and adherence to legal, regulatory, and Genentech guidelines, policies & procedures
  • Building andcultivating important working relationships internally and externally. Providing clinical expertise and feedback regarding operational management that effectively and efficiently guides clinical trials, other studies and investigations. Providing clinical expertise in the development, management, and maintenance of clinical and scientific communications, including research, publications, and educational materials, meeting/event presentations and information, etc. Participating in various internal and external clinical and scientific education programs, meetings, presentations and other forums; providing in-depth clinical and operational expertise and insights regarding the assigned molecules, products and overall therapeutic area(s).
  • When assigned, identifying and completing special projects.
  • Ensuring assigned goals and objectives are met and that assigned projects and other work are completed on time, with high quality, and within budget. 

Example Responsibilities 
 
In this position, you will:
  • Participate in a variety of cross-functional meetings and discussions.
  • Support your manager, medical directors, and peers in gathering information, analyses, research and reporting to support national, regional, and local tactical planning.
  • With assistance from your manager, use national and regional medical plans for the assigned molecules, products, develop and align the tactical plan for your geography of responsibility.
  • Build and cultivate relationships with cross-functional partners, such as franchise sales, marketing, Managed Care, Clinical Operations, Thought Leader Services, Pharmaceutical and Genentech Research and Early Development, Product Development, and various Medical Affairs groups.
  • Build and cultivate relationships with local scientific and medical communities, including study site clinical research staff, clinical investigators, physicians, and other healthcare professionals.
  • As directed, support clinical goals related to investigator-initiated and company sponsored research.
  • Work with a variety of cross-functional partners to discuss plans for implementation and completion of clinical trials. 

Communication/Other -

  • Maintain the highest standards and levels of scientific, clinical and technical expertise in the specific therapeutic area(s) of assignment
  • In collaboration with Scientific Collaboration, attend and lead scientific meetings, forums, venues, etc.
  • As assigned, complete special projects
7/20/17 Scientist/Senior Scientist, Cancer Immunology, Genentech Research Individual Contributor South San Francisco, California

Genentech is inviting applications for a scientist or senior scientist position (ranks equivalent to assistant or associate professor in academia) in the Department of Cancer Immunology. We are seeking an outstanding individual to lead research efforts in the domain of personalized cancer vaccines. Strongest consideration will be given to candidates with strong expertise in cellular immunology and whose research interests are relevant to the problem of vaccine platform design and investigation of mechanism of immunization, adjuvants, and dendritic cell function using in vitro and in vivo approaches. The position will involve close collaboration with an interdisciplinary team involved in the personalized cancer vaccine program, including colleagues from bioinformatics, protein & nucleic acid chemistry, clinical sciences, and biomarkers. The successful candidate will be expected to publish their research work in high quality journals.

7/20/17 Program Manager/Sr. Program Manager - Managed Care Marketing- HIVE Team Individual Contributor South San Francisco, California

Program Manager/Sr. Program Manager - Managed Care Marketing
 
Managed Care Marketing (MCM) plays a lead strategic role in helping Genentech achieve its goals by developing and leading managed care marketing strategies for all Roche pipeline and marketed products across all managed care customer segments, including payers, institutions, healthcare professionals and patients. In addition, MCM plays a critical role to ensure field-based B2B and B2C account management teams have the resources and tools they need to effectively represent Genentech and its portfolio across the customer spectrum.
 
Within MCM is the Healthcare Innovation and Education (HIVE) team responsible for
creating innovative healthcare programs and educational tools that enable better patient care. We create initiatives such as screening and disease awareness programs to improve the healthcare of millions of people living with serious conditions, while also supporting their caregivers. Our programs range from educational workshops to initiatives that raise disease awareness. We create educational tools to empower patients with a greater sense of well being and understanding, even in the face of critical life decisions. Our programs and educational forums shape the discourse of those therapeutic areas that are important to the Genentech business.
 
As a member of the HIVE team, you will lead the development of HIVE strategies, programs and initiatives.
 
In this position, you will focus on the following:
 
Planning and Program Development: 
  • Lead the development of HIVE program offerings and HIVE strategic and tactical plans, including objectives, goals and performance metrics to measure effectiveness and progress against goals
  • Work with other Managed Care Marketing (MCM) team members and other cross functional partners and stakeholders to develop and deliver the managed care value proposition for non-branded programs clarifying project objectives with specific scope, deliverables, required resources and timing
  • Contribute HIVE program insights into cross-functional business strategies and brand plans to ensure a cohesive overall therapeutic approach and to refine HIVE strategies and plans
  • Participate in targeted market research projects aimed at understanding and improving the quality and cost of healthcare delivery and answering relevant payer or other managed care customer questions.  Translate the marketing study outcomes and analyses into key insights and recommendations to further inform and shape HIVE strategies, plans and tactics
 Operations:
  • Coordinate and oversee implementation of HIVE programs, tools and tactics
  • Provide guidance and training to account management teams on appropriate implementation and use of HIVE programs, materials and other tools
  • As appropriate, conduct ad hoc marketing research projects or other analyses and reporting
  • Regularly monitor and report on objectives, goals and performance metrics for HIVE strategies, plans and programs
  • Assume accountability for ongoing and ad hoc HIVE program and materials’ development
  • Commission and manage appropriate resources, vendors and the overall project to assure timely execution and within budgets
 General strategic & tactical responsibilities:
  • As appropriate, participate in development and delivery of 3-year strategic and 1-year tactical Managed Care Marketing (MCM) plans. As assigned, take the lead in translating the 3-year strategic plans into 1-year tactical MCM plans for HIVE programs, including objectives, goals and performance metrics to measure effectiveness and progress against goals
 The successful candidate will demonstrate the following competencies critical to this role:
  • Strategic agility – Links responsibilities with the mission of the organization; focuses on activities that add the most value
  • Decision making – Thinks through problems clearly and logically; is decisive
  • Achieving results – Is goal-directed and persistent; is accountable for meeting commitments and recognizes the contributions of peers
  • Innovation – Generates new ideas; leverages others’ viewpoints; tries new approaches
7/20/17 Manufacturing Technician - BioProcess Entry Level Vacaville, California

POG Manufacturing Technician

 

As a member of our world-class manufacturing team at Genentech's Vacaville site, you'll be responsible for producing innovative biotherapeutic medicines for patients with serious or life-threatening medical conditions. In addition to specific departmental responsibilities below, you will be responsible for compliance to safety requirements, current Good Manufacturing Practices, Standard Operating Procedures and manufacturing documentation. Your job will include interfacing with highly automated production systems and controls, and maintaining areas in a high state of inspection preparedness. 

In our Purification Operations Group, you will: Operate and clean fixed tank and filtration systems, and operate large scale column chromatography systems.

7/19/17 Manager, Case Management (Drug Safety/Pharmacovigilance) Manager with Direct Reports South San Francisco, California

Summary of Position:

Responsible for the leadership and management of all CMT activities within U.S. Drug Safety (USDS) related to individual case safety reports (ICSRs). These responsibilities are performed under the direction of the CMT Head, U.S. Drug Safety.

Job Duties/Responsibilities:

  • Demonstrates high-level proficiency and expertise of drug safety concepts to include monitoring, tracking, and completion in a timely, thorough and accurate manner in accordance with pharmacovigilance (PV) related standards, regulations and Genentech/Roche Standard Operating Procedures (SOPs).

-          Provides routine oversight of CMT-related activities for all products in the Genentech/ Roche portfolio under the direction of the CMT Head.

-          Demonstrates understanding of appropriate labeling documents of Genentech/ Roche molecules and products.

-          Accountable for the design and implementation of strategic, operational and personnel plans for assigned CMT-related activities. This includes, but is not limited to, the intake and submission of spontaneous reports as well as safety support and direction for US Medical Affairs sponsored and supported interventional and non-interventional studies and programs.

-          Participates in the creation of the organizational strategy, goals, and objectives for the CMT, and assists in the implementation of the business plans to support both local and global safety strategies (e.g., rollout of new safety initiatives, implementation of new Health Authority safety requirements).

-          Establishes collaborations with other departments to provide guidance to personnel for interdepartmental and cross-functional team activities, including process improvement standards and metrics.

-          Participates in interactions with Global Drug Safety and other Affiliates to address safety queries, share best practices, and discuss new safety regulations.

-          Responsible for the oversight of ICSR activities and applicable safety commitments for all licensing partners

  •  In collaboration with USDS Leadership Team will drive the organizational strategy, goals, and objectives for the department, and will determine the processes needed to support both local and global safety strategies
  •  Accountable for coaching and developing direct reports (5-6 FTE's) by providing an environment that encourages ongoing personal and professional development

-          Responsible for the performance of assigned personnel against departmental processes, standards and performance goals, and for ensuring successful completion of all training required for the role.

-          Responsible for identification of talent to be developed into potential succession candidates.

  •  Through coordination with the USDS Compliance and Training team to ensure appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance audits

-          Act as Subject Matter Expert (SME) for safety related activities per Genentech/Roche SOPs

Competencies Identified for Success:

  •  Works effectively, independently and collaboratively.
  •  Strong organizational skills, detail oriented and adapts in a dynamic, fast-paced, environment.
  •  Demonstrates ownership, initiative and accountability. 
  •  Exemplifies strong, dynamic leadership and mentoring skills.
  • Ability to interact as an effective team player encouraging collaboration in a multifunctional and multidisciplinary team setting
  • Excellent communication skills, both written and verbal, with credibility and confidence.
  • Exhibits sound decision-making skills with the ability to evaluate and analyze strategies to achieve results.
  • Displays a high level of commitment.
  • Generates enthusiasm and drive for commitment to excellence.

 

7/19/17 Supply Collaborations Project Manager Individual Contributor South San Francisco, California

ROLE
The Supply Collaborations Project Manager manages one or more CIT Technical Collaborations Teams under the direction of the Technical Alliance Manager (TAM) to support clinical trials sponsored by the Tecentriq Cancer Immunotherapy (CIT) franchise involving Tecentriq in combination with other compounds, including both marketed and development compounds supplied by Roche business partners. The Supply Collaborations Project Manager will lead the team in executing the strategies defined and negotiated in the CIT Collaboration Agreements. There will be particular emphasis on ensuring availability to combination clinical trials of Investigational Medicinal Products (IMPs) originating from external pharmaceutical company partners.
 
Managing a matrixed team comprised of internal team members (e.g., Regulatory, IMP Quality, Clinical Supply Planning) and external partners, the Supply Collaborations Project Manager will lead all the activities associated with receipt and supply of partnered IMP through labeling, packaging, release, and distribution by leveraging and/or adapting existing Roche/partner/contract manufacturer (CMO) business processes to meet both the clinical timelines and supply strategies.  Importantly, the Collaborations Project Manager will need to prioritize and manage the simultaneous supply of several IMPs and must execute against demanding timelines. The Supply Collaborations Project Manager will work closely the external partner and/or the external partner’s CMO(s) to ensure that all necessary information is exchanged and activities completed between Roche and the external partner companies in a timely manner to ensure continuity of supply.  The Collaborations Project Manager will be responsible for escalating any issues, risks, or barriers that may impact project timelines to the Technical Alliance Manager for appropriate resolution.  This position requires excellent communication, collaboration, organization, strategic thinking, negotiating and influencing abilities.
 
SPECIFIC RESPONSIBILITIES
  • Lead and facilitate the activities (from receipt and supply of partnered IMP through labeling, packaging, release, and distribution) of the CIT Technical Collaborations Teams in order to ensure seamless, on-time supply of Roche and partner IMPs. This will include developing and executing various supply strategies and plans in collaboration with the Technical Alliance Manager, overseeing deliverables and timelines, prioritizing activities, setting meeting agendas, providing a single point of contact for key internal stakeholders, and identifying, assessing and mitigating project risks.
  • Facilitate technical discussions with internal and external CIT Technical Collaborations Teams members to enable receipt, production, release and shipment of products to clinical sites.
  • Use project knowledge to develop aligned business, operations, and quality/regulatory strategies in collaboration with the Technical Alliance Manager and translating these strategies into short-, mid-, long-term integrated project plans.
  • Develop, maintain, track, and manage an integrated project plan and project dashboard for the supply of multiple IMPs to simultaneous clinical studies to enable accurate reporting and decision making and identification of bottlenecks.
  • Manage the critical path of the project and key project risks, and develop effective risk mitigations plans.
  • Use strong project and organizational knowledge, leadership and active facilitation to enable effective team meetings, high performing teams, and timely, smart decision making.
  • Manage team-level and corporate processes effectively, using strong project and process knowledge, to drive team deliverables.
  • Develop and/or adapt relevant business processes as needed, and drive for continuous improvement.
7/19/17 Technical Alliance Manager - Supp Collab Individual Contributor South San Francisco, California

The Technical Alliance Manager (TAM) will manage the portfolio of supply collaborations identified by the Tecentriq Cancer Immunotherapy (CIT) franchise that are needed to support clinical trials involving Tecentriq in combination with other compounds, including both marketed and development compounds supplied by Roche business partners. The TAM will be the Pharma Technical Operations (PT) Point of Contact (PoC) to the Tecentriq Life Cycle Team (LCT), Global Development teams, Roche Partnering, and Legal for matters pertaining to the supply of Tecentriq and 3rd party compounds for combination clinical trials managed by Roche or external business partners.
 
In this role, the TAM will ensure alignment of all CMC deliverables, including product supply, for Investigational Medicinal Products (IMP) and/or commercial material supply with the LCT strategy, Clinical Development plans (e.g., priority and timing of clinical studies), and all clinical Collaboration Agreements.  The TAM will serve as PT’s PoC for all due diligence and business activities involving potential clinical collaboration deals managed by Roche Partnering.  During this “Get” stage of the Roche partnering process the TAM will provide feasibility assessments and input on the supply-related terms in the collaboration agreements, as well as develop the execution strategy that best ensures availability of supply from the 3rd party.  In parallel with or after (“Manage” stage) negotiation of the clinical Collaboration Agreement the TAM, along with TCT members, will define the supply chain strategy and negotiate the appropriate clinical supply and quality agreements governing the supply of the 3rd party compounds.  
 
Throughout the Get and Manage stages of the Roche Partnering process the TAM will serve as the PT PoC to Roche’s external partner companies for supply chain business and relationship matters, and will develop and manage mutually beneficial, long-term business relationships with the external partners. Additionally, the TAM will develop a long-term strategy for commercialization of therapeutic combinations that show clinical success.  In his/her role, the TAM ensures timely, appropriate information flow between TCT members, to PTD functional management, and to CIT-relevant governance committees to ensure transparency and inform good decision making. He/she is also accountable to the Atezo Life Cycle Teams (LCTs), Global Development teams, Roche Partnering and PTD functional leaders for CIT supply project planning, scheduling, resourcing and reporting for the TCTs.
 
 
This position requires excellent communication, collaboration, organization, strategic thinking, negotiating and influencing abilities.
 
SPECIFIC RESPONSIBILITIES
  • Serve as the PT Point of Contact to the Tecentriq Life Cycle Team, Global Development Team, Roche Partnering, and Legal for matters pertaining to the supply of Tecentriq and 3rd party compounds for combination clinical trials; collaborates closely with other Life Cycle Team members to define and is accountable to deliver the CIT supply project strategy, objectives and plans.
  • Lead partner CMC due diligence team during collaboration development.
  • Write or coordinate and review the relevant drug supply sections of Collaboration Agreements, and directs and/or leads the drafting and negotiation of Clinical Supply and Quality Agreements in collaboration with subject matter experts.
  • Provide overall leadership for all Technical Collaborations Teams supporting Tecentriq combination studies, including developing a drug supply strategies in alignment with Tecentriq LCT strategy, Clinical Development plan(s), relevant clinical collaboration agreements, and corporate goals. Accountable for execution of the CIT supply strategy for combination clinical trials managed by Roche or external business partners.
  • Monitor, track and report progress against Technical Collaborations Team goals and approved plans and provides regular updates to the LCT or GDT and relevant governance committees or leadership meetings.
  • Communicate and work regularly with Roche external business partners to maintain mutually beneficial, long-term business relationships and resolve contractual issues as required.
  • Support Technical Collaborations Teams in achieving goals, timelines, milestones, and resource forecasts in collaboration with Roche external business partners by removing roadblocks, securing resources, and driving decision making at the LCT, GDT and relevant governance committees.   
  • Supervise Technical Collaborations Teams members in a matrix environment.
  • Establish effective business, decision-making and risk management processes for Atezo supply collaborations.
  • Anticipate and identifies issues, develops contingency and risk mitigation plans, and communicates the potential impact to the relevant governance committees.
  • Partner with functional area management and seeks input from functional area forums and committees to ensure that expertise is provided as necessary.
  • Drive for continuous improvement of associated business processes.
     
7/19/17 Manufacturing Technician - BioProcess Entry Level Vacaville, California

Manufacturing Technician:
 
Responsible for producing innovative bio-therapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment; maintaining areas in high state of inspection preparedness, and utilizing business systems for inventory and process management.   Maintain records to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP). Participate in the routine production of mammalian cell culture products within the Vacaville Manufacturing Facility, operating in at least one of the following production areas:
 
Centralized Manufacturing Services (CMS):  Provide support to Manufacturing and Quality Control to meet production demands.  Duties include but are not limited to: CIP/SIP of portable and Freeze/Thaw tanks; clean, assemble, and autoclave 20L fermenters; prepare and autoclave manufacturing assemblies; autoclave solutions; clean, kanban, and deliver lab ware, glassware, parts and equipment; perform weighing and dispensing of components; handle and aliquot hazardous materials;  Provide quality materials and service to our customers.
 
Job Responsibilities:
  • Follow established safety and environmental guidelines and procedures for all work performed. 
  • Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions
  • Fosters safe work practices
  • Operate systems that clean and sterilize tanks and filtration systems. 
  • Prepare materials for the production process.
  • Exhibit detail oriented documentation skills to ensure Right-First-Time operations (e.g. tickets, labels, equipment reading)
  • Escalate process issues as necessary to ensure resolution of issue
  • Comply with cGMP, SOP and manufacturing documentation.
  • Use automation to perform production and equipment operations.
  • Provide support to Manufacturing to meet production demands.
  • Assemble and prepare equipment for production.
  • Communicate effectively and professionally work in a team environment.
7/19/17 Senior Clinical Program Leader - NORD (Neuroscience, Ophthalmology and Rare Diseases) Team Leader Basel-Town

Senior Clinical Program Leader - NORD (Neuroscience, Ophthalmology and Rare Diseases)

Purpose of the role:

  • The Senior Clinical Program Leader (SCPL) NORD is accountable for the operational strategy, planning and execution of the clinical development portfolio up to LIP for the designated Discovery and Translational Area (DTA).
  • This person provides the primary interface between the NORD DTA and pRED’s the Clinical Program Execution (CPEX) function in Clinical Operations, oversight for program and study management, line management of key operational roles.
  • As a member of the NORD DTA Portfolio Committee (DTA-PC) and the Development Review Committee (DRC), the SCPL, NORD is empowered to make key operational strategic decisions and provide technical review on behalf of clinical operations.
  • As member of these committees, the SCPL, NORD provides direction and therapeutic area operational expertise and ensures effective implementation.
  • The SCPL, NORD is accountable for delivery of programs with respect to quality, timelines, budget and ensures resources from the sub-functions of CPEX are available to the DTA. The SCPL, NORD defines the clinical operations sourcing strategy for their designated DTA and is accountable for the placement of programs.
  • This person will have a good working relationship with internal and external stakeholders and have oversight of the management of Key Accounts with investigators and academic centers.
  • This person will contribute toward the design of pRED CDPs and clinical protocols to enable flexible and innovative development of operational strategies with appropriate scenario planning, which include forecasting of timelines, resources and budget, as well as program level feasibility assessment.
  • The SPL NORD will have responsibility as line manager of CPLs, SL Team Leaders and Documentation Specialist for the designated therapeutic area:
    • leading assessments/evaluations on topics that relate to study management and study leadership
    • talent management and development of Study Leader group, change management, communication for leadership teams. 

 

7/19/17 Managed Care Medical Communications Scientist Individual Contributor South San Francisco, California

The Managed Care Medical Communications (MCMC) Scientist communicates relevant and timely clinical information to external customers involved in evidence-based healthcare decisions (eg. managed care organizations, private and government health plans, third party payers, pharmacy benefit managers, specialty pharmacies, compendia publishers, guideline bodies and technology assessment entities). The MCMC Scientist is expected to evaluate and interpret medical literature, abstract and write medical information in various response formats, conduct scientific and clinical presentations, and apply managed care concepts and knowledge to customize our services for managed care customers. Medical information is prepared and communicated using many formats (response documents, formulary dossiers, slide presentations, compendia submissions, web-based media, scientific meetings, etc.). This position is also a member of medical teams representing managed care and emerging customer data needs.The MCMC Scientist contributes to departmental efforts to develop, implement or further improve business processes and operations. This may include non-clinical and non-product types of responsibilities and activities such as systems and technology, training, quality assurance, and writing policies and procedures.Candidates should have a sound understanding of legal and regulatory topics to adequately apply Medical Communications (MC) policies and practice. He/she must work effectively with members of the MCMC/MC staff and other cross functional business partners to meet the information needs of managed care customers, contribute to corporate wide goals, and support the safe and effective use of Genentech products. 


Key Responsibilities
  • Develop and maintain a sound understanding of legal and regulatory topics to adequately describe the basis of MCMC policies and practice
  • Work effectively with members of the MCMC Team and other cross-functional business partners to meet the information needs of managed care customers, contribute to corporate wide goals, and support the safe and effective use of Genentech products
  • Communicate relevant and timely clinical information on our marketed products and compounds in late development
  • Communicate effectively with external customers involved in evidence-based healthcare decisions, including but not limited to managed care organizations, private and government health plans, third party payers, pharmacy benefit managers, specialty pharmacies, compendia publishers, guideline bodies and health technology assessment entities 
  • ?Conduct scientific and clinical presentations, and apply managed care concepts and knowledge to customize our services for managed care customers
  • Prepare and communicate medical information using many formats (response documents, formulary dossiers, slide presentations, compendia submissions, web-based media, scientific meetings, etc.)
  • Review promotional marketing materials intended for the managed markets and payer environment
  • As assigned, act as a member of U.S. Medical Affairs (USMA) Medical Teams; representing managed care and emerging customer data needs
  • Effectively, appropriately, and responsibly use resources to support the use and access of our marketed products
  • Contribute to departmental efforts to develop, implement or further improve business processes and operations, which may include non-clinical and non-product types of responsibilities and activities, such as systems and technology, training, quality assurance, and writing policies and procedures
7/18/17 Analytics Manager Manager South San Francisco, California

The Analytics Manager/Senior Manager in Marketing Science (MS) participates actively in Genentech’s commercial planning efforts by providing objective quantitative data analyses and insights to address business issues and to support strategic decision making for the Company. He/she utilizes SAS and advanced statistical techniques to:

1) Increase understanding of effectiveness/ROI of all promotional efforts, including marketing and field force efforts and to advise on the placement and targeting of future initiatives

2) Analyze longitudinal patient-level data to generate market insights and measure performance for brand teams, as well as to inform primary market research, and

3) Measure the impact of business unit and multi-product initiatives on product-specific performance

 

The Analytics Manager/Senior Manager has a broad understanding of pharmaceutical data, including sales and claims data, and which source to leverage in order to answer business questions most effectively.  He/she works with functional partners and Brand team colleagues to understand business objectives and to apply analytics for marketing projects. The Analytics Manager/Senior Manager conducts critical analyses by integrating multiple data sources to provide an objective viewpoint and recommendations to the Commercial organization.

 

MAJOR RESPONSIBILITIES:


1. Design and execute analytical measurement techniques to gauge the effectiveness of brand initiatives (40%)

2. Make recommendations to Brand teams and other stakeholders on the effectiveness of different tactics (20%)

3. Serve as a subject-matter expert on analytics, data and measurement as it relates to the brand landscape (20%)

4. Partner effectively with other departmental (MA&S) colleagues to provide holistic analytical insights (10%)

5. Proactively learn from others and share methodologies/approaches for complex analyses (10%)


7/18/17 Analytics Manager/Senior Manager - Market Analysis and Strategy Individual Contributor South San Francisco, California

The Analytics Manager/Senior Manager in Marketing Science (MS) is an integral business partner in Genentech’s commercial planning efforts. He/she is responsible for designing and delivering quantitative data analyses to address business issues, synthesizing objective insights, and guiding strategic decision making for the Company.

 

He/she leads (hands-on) the analytics process to:

  1. Drive and influence sales and marketing strategic and tactical planning through development of effectiveness/ROI assessments of promotional efforts, including but not limiting to marketing-mix
  2. Identify brand and market issues, opportunities, and needs through appropriate longitudinal patient-level data analyses; develop insights and effectively communicate actionable recommendations to senior leadership
  3. Provide brand perspective on overall portfolio and business-unit initiatives 

The Analytics Manager/Senior Manager has a broad understanding of pharmaceutical data, including sales and claims data, and which source to leverage in order to answer business questions most effectively.

  

MAJOR RESPONSIBILITIES

  1. Design and execute analytics-based effectiveness measurement of brand initiatives; and make strategic, tactical and investment recommendations to brand teams and other stakeholders
  2. Serve as a subject-matter expert on analytics frameworks, data and measurement as it relates to the brand and market landscape
  3. Partner effectively with other commercial and company-wide departmental colleagues, including by not limiting to MA&S, to provide holistic analytical insights
  4. Proactively learn from others in Marketing Science, and act as a source of knowledge to design and deliver new methodologies/approaches to solve complex business problems
7/18/17 Marketing Science, Manager/Sr. Manager - Market Analysis and Strategy Individual Contributor South San Francisco, California

The Analytics Manager/Senior Manager in Marketing Science (MS) participates actively in Genentech’s commercial planning efforts by providing objective quantitative data analyses and insights to address business issues and to support strategic decision making for the Company. He/she utilizes SAS and advanced statistical techniques to:

1) Increase understanding of effectiveness/ROI of all promotional efforts, including marketing and field force efforts and to advise on the placement and targeting of future initiatives

2) Analyze longitudinal patient-level data to generate market insights and measure performance for brand teams, as well as to inform primary market research, and

3) Measure the impact of business unit and multi-product initiatives on product-specific performance

 

The Analytics Manager/Senior Manager has a broad understanding of pharmaceutical data, including sales and claims data, and which source to leverage in order to answer business questions most effectively.  He/she works with functional partners and Brand team colleagues to understand business objectives and to apply analytics for marketing projects. The Analytics Manager/Senior Manager conducts critical analyses by integrating multiple data sources to provide an objective viewpoint and recommendations to the Commercial organization.

 

MAJOR RESPONSIBILITIES:

1. Design and execute analytical measurement techniques to gauge the effectiveness of brand initiatives (40%)

2. Make recommendations to Brand teams and other stakeholders on the effectiveness of different tactics (20%)

3. Serve as a subject-matter expert on analytics, data and measurement as it relates to the brand landscape (20%)

4. Partner effectively with other departmental (MA&S) colleagues to provide holistic analytical insights (10%)

5. Proactively learn from others and share methodologies/approaches for complex analyses (10%)


7/18/17 Regulatory Program Director/Associate Regulatory Program Director, Regulatory Compliance Individual Contributor Vacaville, California

Location: Vacaville, CA
 

There is an opportunity in the Pharma Technical Regulatory (PTR) organization at the Associate Regulatory Program Director/Regulatory Program Director.  The candidate will provide regulatory support and oversight to the Vacaville (VV), CA facility as well as to regulatory products teams in support of regulatory goals and objectives. 

 

In this capacity the candidate will lead site specific regulatory submissions and also product related regulatory submissions.  He/she will work closely with VV Quality colleagues, technical and manufacturing key stakeholders, and the global PTR network to assure Genentech/Roche product and regulatory expectations are met. 

 

He/She will provide regulatory support for the VV Quality System including change management, discrepancy management, and inspection management.  The incumbent will complete regulatory impact assessments for change control and discrepancies within the TrackWise system and provide inspection preparation, conference room, and inspection response support.  He/She will participate in Quality Review Boards, governance committees, and other site forums as appropriate. 

 

The incumbent will support timely compilation and submission of health authority notifications for significant issues and health authority inspection responses. 

 

He/She will lead submissions and generate CMC regulatory submission information in support of product license applications/supplements, including participation in filing strategy development and readiness activities.  The incumbent will support and participate in communications with FDA and other health authorities on behalf of the site and/or to facilitate review and approval of VV related submissions. 

 

He/She will assist with coordination and monitoring of regulatory commitments related to the site.  The incumbent will provide regulatory support for VV products through close collaboration with PTR Technical Regulatory Leaders and regulatory product teams.  He/She will collaborate with regulatory product teams in support of product activities such as technology transfer teams.

The candidate will lead and/or participate in cross-functional project teams and work effectively with multiple disciplines and across levels within the Roche organization.  He/she will support U.S. and global filings as appropriate and as requested by corporate partners.  Additional responsibilities will include supporting and leading departmental operational excellence and business process initiatives, as well as proactively communicating with regulatory and cross-functional personnel in support of internal goals.

The Associate Regulatory Program Director/Regulatory Program Director must maintain a high level of professionalism, efficiency, and follow-through as the regulatory representative and liaison for the VV site and for assigned products. 

 

The successful candidate will possess a strong understanding of regulatory, quality and compliance, and demonstrate effective problem solving, excellent interpersonal skills, and the ability to prioritize multiple tasks.  He/she must have a proven ability to communicate effectively in both a written and verbal format, and demonstrated effective partnering on projects and issue resolution.  The ability to work both independently as well as collaboratively in a team structure, along with a proven track record of working well under pressure, is necessary to be successful in this position.

 

Important Information

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

If you have a disability and need an accommodation in connection with the on-line application process, please email us at US.Accommodation@roche.com.

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