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Job Title: Translational Medicine Lead, SGRDC
In collaboration with Head, TM/ED and the project team, this position has shared accountability for developing the overall translational medicine strategic plan, early development plan, and TM resource allocation for projects in the respective therapeutic area from Milestone 0 through Proof-of-Concept. A close working relationship to Head, Genetics/Genomics, SGRDC and the interface with Bioinformatics and the Biomarker Core will be important for success. This will be a highly matrixed position for which alignment on goals and responsibilities will be paramount. TM Lead is expected to actively engage into cross-TA discussions of TM strategies, expanding his/her perspective (eg. targets/pathways effecting phenotypes in different TA's).
Principal Duties & Responsibilities:
· Provide the medical and TM perspective (when appropriate) and TM/ED plans in collaboration with members of the project team for projects in the TA early portfolio at reviews and other strategic meetings. Provides medical input for target selection and definition of disease/operation
· While not a contributing member to all project teams in the TA, helps to ensure that there is adequate project team membership for medical (when appropriate) and TM/ED activities
· Understands each project's clinical development and TM/ED plan
· Facilitates review of TM/ED plan with TM/ED oversight mechanism (*TBD)
· Works with project teams and the Research and Development Boards to ensure that projects in the TA meet criteria for milestone advancement
· Serves as a member of the TM Senior leadership team (TM SLT)
· Provides strategic TM/ED input on future of the SGRDC portfolio
Complexity & Problem Solving:
· Deliver Translational Medicine Strategy across TA projects in the SGRDC portfolio to assure that TM plans integrate the best science, are fully aligned with the strategic objectives of the projects, and allow fast and efficient assessment of the early clinical candidates leading to robust fact-based Go/No-Go decisions - Requires extensive discussions/consultations with internal and external scientific/medical experts and other key functions including Discovery (Immunology), DSAR and CSO SCPs.
· Rapidly identify and resolve scientific and operational issues that arise during the conduct of clinical studies - Requires interactions with multiple partners in the Clinical Sciences and Operations SCP and with representatives of external vendors.
· Most significant contacts include the Research teams in the SGRDC, the Clinical Sciences and Operations SCP, the DSAR SCP, Regulatory Affairs, Pharmacovigilance, Marketing, Health Economics. Key interface with academic collegues
Owns (but in collaboration with Project Team)
· Translational Medicine Strategy for multiple projects; TM component of Pre-POC GDP/Clinical Development Plans and clinical protocols
· Guide implementation of approved Translational Medicine Plans
· Selection of Phase 1 and 2 study designs and endpoints
Knowledge & Skills:
· Thinks mechanistically about disease with early R&D efforts, including biomarker planning, human credentialing, and PoBA/PoC design
· Embraces, understands, and contributes to evolving model for early R&D, emanating from Global R&D governance ("quick to PoC")
· Manages a complex matrix organizational structure and reporting relationships
· Thinks independently and agnostically with respect to TA pipeline and across overall SGRDC portfolio.
· Finds compromise by practicing a facilitated leadership model and aligning on goals between TA, Science Portfolio, and TM/ED