VP / Medicines Development Leader - Molibresib (BET inhibitor)
Oncology Clinical Development
Waltham, MA or Collegeville, PA, USA
MD, PhD, PhD and/or MD, DO, Other
November 26, 2019
Corporate (Biotech or Pharmaceutical)
November 26, 2019-January 26, 2020
Multiple positions available for the following Oncology assets: Molibresib (BET inhibitor), Dostarlimab (PD-1), PRMT5 inhibitor-GSK 3326595, and TIM 3 inhibitor-TSR022). The core purpose of the VP / Medicines Development Leader (MDL) is to strategically lead the optimal global development of a medicine, acting as the single point of accountability for the medicine from C2P2 to approval in first major market, but substantially contributing and influencing from pre-C2P2 to post-launch life-cycle management, to ultimately deliver differentiated medicines of value. By working with the various stakeholders across R&D and Pharma, the MDL defines the strategic vision and operational plan for the medicine, aligning it with the overall organizational strategy. The MDL creates and leads the matrix Medicine Development Team (MDT), which has responsibility for representing all the various R&D and commercial disciplines required to optimally deliver the development of the medicine (including clinical development, medical affairs, safety, regulatory, commercial and product development and manufacturing, among others).
- Act as a single point of accountability in GSK for all aspects of a medicine (in this case, the BET inhibitor Molibresib) in development globally from C2P2 to approval in first major markets.
- Establishes a compelling vision for the medicine; positions the medicine within the R&D strategy taking the competitive landscape into account; Translate GSK’s strategy into asset strategy and actionable plans for multiple areas or functions.
- Delivers differentiated medicines of value for patients, stakeholders and markets, through an evidence package that supports regulatory approval, market access, and product life cycle.
- Prioritizes and maximizes the asset’s portfolio options including developing multiple indications. Makes clear evidence-based go / no go / accelerate decisions, based on whether the results fulfil the strategy set out for the medicine, and identify clear inflection points.
- Embeds core processes including cost efficiency, adoption of new technology, risk identification & management, compliance with policy.
- Identifies and aligns resources (people and financial), team objectives and strategies behind the vision to ensure successful project completion.
- Proactively identifies unmet medical needs that could be addressed through line extensions.
- Asset single point of contact and spokesperson to senior management and senior boards (e.g., Chief Scientific Officer, Head of Development, Chief Medical Officer, President of Pharma, Development Review Board and Portfolio Investment Board) and other relevant internal governance committees and external Advisory Committees as needed.
- Increases visibility amongst the external communities (physicians, regulators, patients, payers), to bring medical solutions to patients with unmet medical needs, thereby enhancing reputation of GSK.
- Accountable for developing an ongoing patent strategy for the asset.
- M.D., M.D./Ph.D., Ph.D. or Pharm.D. required.
- Filing experience BLA/NDA/ MAA submissions as a core responsibility and have led development programs.
- Considerable pharmaceutical industry experience is required.
- Prior significant experience in leading successful development and registration of medicines is highly preferred.
- Deep experience in product development and/or commercial, especially in late phase development (from PoC onwards), clinical trial management with significant operational complexity, post-approval studies, regulatory and manufacturing compliance.
- In-depth experience creating the strategy for pre- and post-marketing studies, and driving the lifecycle process.
- Business acumen and experience of managing a sizable P&L which has organizational impact. Experience of building budgets and then leading the strategic and budget planning process.
- Track record of leading with high operational complexity. Including global, geographically dispersed teams, multi-disciplinary structures with high accountability, minimal authority, and multiple lines of reporting.
About the Employer
GSK Oncology has a strong commitment to the discovery and development of new innovative therapies for patients suffering from hematological malignancies or solid tumors, specifically in four cutting-edge areas of research: Cancer Epigenetics, Immuno-Oncology, Cell & Gene Therapies, and Synthetic Lethality.
1250 South Collegeville Road
Collegeville, PA 19426 USA
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