Senior Director, Early Phase CMC Medicine Research Leader
GSK
August 21, 2026
Remote friendly (Boston, MA)
United States
Operations
Senior Director, Early Phase CMC Medicine Research
Responsibilities:
- Ensure successful CMC delivery for GSK early phase portfolio (Rx and Vx) through coaching, training, mentoring, and recruiting CMC project matrix leaders.
- Lead early CMC R&D of clinical products from C2LO through C2P3, providing strategic CMC input at/ before C2LO; oversee candidate selection, Phase 1 process development, and pre-clinical/Phase 1 supply; transition accountability to Development & Industrialization for Phase 3.
- Recruit/retain/develop CMC matrix leaders; design next-generation ways of working (design by intent, phase-appropriate practices, GenAI).
- Appoint CMC leaders to projects; assess/escalate early phase CMC risks.
- Ensure appropriate CMC input into business development opportunities (diligence leads and approval of CMC diligence/risk assessments).
- Act as CMC accountable person for early phase objectives and for all CMC/supply chain aspects from Lead Optimization to handover.
- Define integrated CMC/supply chain/quality/CMC regulatory strategy; lead delivery of CMC strategy/plan via matrix team and R&D/CDMO network.
- Mentor/coaching of workstream leads and key talent.
Basic Qualifications (Required):
- PhD (or equivalent) in chemistry/pharmaceutical sciences/chemical engineering or related, or equivalent experience.
- 15+ years in CMC/pharmaceutical development (drug substance/product, analytical, manufacturing, supply chain) in early phase.
- Proven matrix leadership of cross-functional teams in pharma/biotech/vaccines R&D.
- Strong knowledge of preclinical and Phase 1 roadmap (and working knowledge of Phase 2/3).
- Demonstrated matrix leadership, communication, and problem-solving/decision-making.
Preferred Qualifications:
- Knowledge of early phase regulatory filing strategies; Phase 1 acceleration and downstream impact.
- Clinical manufacturing and end-to-end supply chain design; experience across Rx and Vx.
- Portfolio/product/project management; enterprise/business/financial context; governance positioning; collaborative/inclusive leadership.
- Agile/continuous improvement mindset; willingness to travel.
Compensation/Benefits (US): Annual base salary range: $202,125–$336,875 (Cambridge/Waltham/Rockville/San Francisco) or $183,750–$306,250 (other US locations). Bonus and eligibility for share-based long-term incentive; health/insurance, retirement, paid holidays/vacation, paid caregiver/parental and medical leave.
Responsibilities:
- Ensure successful CMC delivery for GSK early phase portfolio (Rx and Vx) through coaching, training, mentoring, and recruiting CMC project matrix leaders.
- Lead early CMC R&D of clinical products from C2LO through C2P3, providing strategic CMC input at/ before C2LO; oversee candidate selection, Phase 1 process development, and pre-clinical/Phase 1 supply; transition accountability to Development & Industrialization for Phase 3.
- Recruit/retain/develop CMC matrix leaders; design next-generation ways of working (design by intent, phase-appropriate practices, GenAI).
- Appoint CMC leaders to projects; assess/escalate early phase CMC risks.
- Ensure appropriate CMC input into business development opportunities (diligence leads and approval of CMC diligence/risk assessments).
- Act as CMC accountable person for early phase objectives and for all CMC/supply chain aspects from Lead Optimization to handover.
- Define integrated CMC/supply chain/quality/CMC regulatory strategy; lead delivery of CMC strategy/plan via matrix team and R&D/CDMO network.
- Mentor/coaching of workstream leads and key talent.
Basic Qualifications (Required):
- PhD (or equivalent) in chemistry/pharmaceutical sciences/chemical engineering or related, or equivalent experience.
- 15+ years in CMC/pharmaceutical development (drug substance/product, analytical, manufacturing, supply chain) in early phase.
- Proven matrix leadership of cross-functional teams in pharma/biotech/vaccines R&D.
- Strong knowledge of preclinical and Phase 1 roadmap (and working knowledge of Phase 2/3).
- Demonstrated matrix leadership, communication, and problem-solving/decision-making.
Preferred Qualifications:
- Knowledge of early phase regulatory filing strategies; Phase 1 acceleration and downstream impact.
- Clinical manufacturing and end-to-end supply chain design; experience across Rx and Vx.
- Portfolio/product/project management; enterprise/business/financial context; governance positioning; collaborative/inclusive leadership.
- Agile/continuous improvement mindset; willingness to travel.
Compensation/Benefits (US): Annual base salary range: $202,125–$336,875 (Cambridge/Waltham/Rockville/San Francisco) or $183,750–$306,250 (other US locations). Bonus and eligibility for share-based long-term incentive; health/insurance, retirement, paid holidays/vacation, paid caregiver/parental and medical leave.