Related skills
cross-functional leadership portfolio management clinical development ema fda๐ Description
- Partner with Clinical Ops and Medical to define and execute development strategies.
- Drive program-level decisions, including risk assessment, trade-offs, and prioritization.
- Ensure asset strategy aligns with clinical execution and regulatory pathways.
- Present program updates, risks, and opportunities to Executive Leadership and Board.
- Serve as central integrator across Medical, Clinical Ops, Regulatory, Biometrics, CMC, Commercial.
- Lead assets with hands-on program leadership from early development to NDA readiness.
๐ฏ Requirements
- Advanced degree (PhD, MD, PharmD) preferred; equivalent experience considered.
- 20+ years in pharma/biotech with cross-functional drug development leadership.
- Lead integrated clinical development plans (CDPs).
- Experience with regulatory interactions (FDA, EMA).
- Partner with Clinical Ops, Medical, Regulatory as a peer.
- Hands-on, execution-focused leadership in a lean, matrixed environment.
๐ Benefits
- Remote work opportunities within the United States.
- Travel to Cambridge, MA several times a year.
- Equal Opportunity Employer; accommodations available during selection.
- Inclusive, collaborative culture with emphasis on accountability.
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