The Drug Safety R&D (DSRD) Therapeutic Area Lead (TAL) is accountable for development and implementation of the safety and risk management strategy for within-TA (note: TA is used synonymously with RU in this document) projects from Idea to Loss of Exclusivity (LoE), ensuring that strategy is aligned with the overall objectives of the TA, and enabling those TA goals to be met. In addition, as a member of TA-specific governance bodies, the TAL is expected to fully engage such that they contribute expertise to all aspects of programs within the TA. The TAL ensures provision of DSRD expertise within TA for assessment of potential licensing or acquisition deals, including where necessary, identification of resources to participate on due-diligence teams. Through a matrix or hard-line reporting relationship, the TAL will provide ongoing guidance and mentorship to within-TA drug safety team leads (DSTLs) from Idea to loss of value. Through active external surveillance, consultation with external key opinion leaders, and collaboration with internal subject matter experts, TAL drives organizational and regulatory acceptance of innovative scientific approaches, biomarker strategies and regulatory packages to accelerate portfolio deliverables. This role will bring unique subject matter expertise to deliver disproportionate value to management and resolution of portfolio issues. In close collaboration with RDRU leaders and other partnerlines (e.g., Biomedicine Design), TAL will play an important role to accelerate identification of new targets, capsids, and molecules to build RDRU pipeline. Direct or matrix manager of 25-30 colleagues engaged in RDRU portfolio. ROLE RESPONSIBILITIES
- Perform all regulatory responsibilities in compliance with applicable regulatory standards
- Management of Drug Safety Team Leads (DSTLs) and/or other DSRD portfolio staff such as Portfolio Liaisons, Licensing and Acquisition leads. These may be direct reports or matrix management relationships.
- Drives organizational and regulatory acceptance of innovative scientific approaches, biomarker strategies and regulatory packages to accelerateportfolio deliverables in close collaboration with the Research, Regulatory, and Clinical Lines.
- Assures that expedited packages are achieved through active external surveillance, consultation with external key opinion leaders, and collaboration with internal subject matter experts.
- As the Drug Safety representative to the TA specific bodies (such as TA-Technical Review Committee), provides strategic direction, scientific expertise, and resource prioritization and is accountable for delivery of the Drug Safety component of the TA from Idea to LoE.
- Point of accountability for the development and delivery of comprehensive programmatic safety strategies developed by DSTLs to ensure rapid progression through Research and Development.
- Oversees development and approve implementation of biomarker and risk management strategies developed by Drug Safety Team Leads to ensure progression of compounds and programs within TA.
- Review and endorse Issues Management Plans in consultation with Global Portfolio Safety Review Committee (GPSRC).
- Ensures that the DSRD strategy specific to that TA is aligned with Program objectives and priorities.
- Responsible for within-TA prioritization of projects and/or project related activities, to guide resourcing decisions within DSRD.
- Provides or ensures provision of DSRD expertise within TA for assessment of potential licensing or acquisition deals, including participation on assessment teams as required.
- Accountable for DSRD line activities and resources supporting safety strategies in TA, including line review and technical quality of toxicology deliverables.
- Oversees the review and approval of toxicology plans and endorse any needed exceptions to standard protocols.
- Reviews and endorses DSRD components of stage gate documentation, including CAN documents, Nonclinical Overviews (NCOs), Investigator Brochures (IBs), etc through global registration.
- Ensures that study reports and regulatory submission documents are consistent in their interpretation and are aligned with risk management strategies.
- Review and endorsement of regulatory responses and participation in Regulatory Agency interactions, as required.
- Final approval of the use of within-TA compounds in studies which employ toxicologically relevant doses and/or are intended to assess safety.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
- Ph.D., and/or DVM
- Scientific excellence, to include at least 15 years of experience in basic and applied research and development preferably in pharma and/or mid-size/large biotech; solid scientific track record, exemplified by publications, and overall stature in the field of pharmaceutical R&D
- Prior extensive experience in design and interpretation of safety evaluation studies; first-hand experience as DSTL spanning all stages of drug development including Registration; experience as pathology lead or issues management lead are desirable
- Documented success in partnering with other senior leaders to ensure alignment of issue resolution strategies across DSRD and Pfizer enterprise
- Makes good scientific and regulatory decisions based on a mixture of analysis, wisdom, experience, and judgment. Can make high quality decisions in an ambiguous environment, e.g., without access to all data that might be desired
- First-hand experience in non-clinical safety of gene therapy molecules in preclinical and clinical stages of development
- Recognized externally as a thought leader in safety assessment of novel modalities (publications or as a member of external consortia)
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Research and Development