Executive Director, Medicine Development Leader
GSK
full-time
Posted on:
Location Type: Hybrid
Location: Massachusetts • Pennsylvania • United States
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Salary
💰 $202,125 - $336,875 per year
Job Level
About the role
- Lead the global development strategy for a medicine, ensuring alignment with organizational goals.
- Chair a cross-functional Medicine Development Team (MDT) to achieve clinical, regulatory, and commercial milestones.
- Make evidence-based decisions to prioritize and advance the medicine’s portfolio options, including new indications.
- Ensure compliance with quality standards, risk management, and regulatory requirements.
- Incorporate patient insights into development plans to enhance patient focus.
- Represent the medicine to senior leadership, external stakeholders, and regulatory bodies.
- Post-approval, provide key support to the Medicine Commercial Team (MCT) in the first major markets ensuring the MDT provides optimal support to registration, including Post-Marketing Requirements (PMRs) and life cycle management (LCM) in the major markets.
- Partner with the Pipeline Project Manager (PPM), energize and motivate the MDT to drive a high-performing team and operational delivery of the project, including setting team objectives to ensure successful project delivery, including options for acceleration, parallel indication development, and smart risk-taking.
- Partner with R&D Business Development, leading the development planning for a prospective in-licensed asset by bringing together input from the relevant functions and TA experts to develop a Medicine Profile (MP) and development plans including but not limited to clinical feasibility, regulatory planning, and CMC risk mitigation.
Requirements
- Advanced degree including MD, PhD, PharmD, MBA, MS
- Extensive and broad experience in drug development expertise in the global pharmaceutical/biotechnology industry
- Filing experience with BLA/NDA/MAA submissions as a core responsibility.
- Strong leadership and decision-making skills and prior experience leading development programs.
- Experience in the entirety of drug development across the R&D/commercial life cycle including Discovery, late-stage Development, Regulatory, Manufacturing Medical, and Commercial.
- Experience in product development and/or commercialization, in late-phase development (from clinical PoC onwards), clinical trial management, post-approval studies, regulatory and manufacturing compliance.
Benefits
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Applicant Tracking System Keywords
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Hard Skills & Tools
drug developmentBLA submissionsNDA submissionsMAA submissionsclinical trial managementregulatory compliancemanufacturing compliancelife cycle managementclinical feasibilityCMC risk mitigation
Soft Skills
leadershipdecision-makingteam motivationcross-functional collaborationevidence-based decision makingpatient focusstrategic planningoperational deliveryrisk managementcommunication
Certifications
MDPhDPharmDMBAMS