Position Summary
- Senior Director, Global Clinical Development (Clinical Development)
Responsibilities
- Serve as clinical point of accountability; own overall clinical development plan for asset(s) across indications/tumor types.
- Ensure studies align with target label indications and meet regulatory, quality, medical, and access goals.
- Lead, develop, motivate, and achieve results through matrix teams; direct manage Clinical Trial Physicians (CTPs).
- Accountable for clinical contributions to indication strategy (registrational and non-registrational studies).
- Manage CTPs (hiring, training, mentoring); may serve as CTP as necessary.
- Partner with Clinical Scientists for study design, execution, analyses; accountable for clinical content for CSRs, regulatory reports, briefing books, and submission documents.
- Ensure GCP compliance and quality-focused clinical conduct.
- Represent Clinical Development externally/internal forums (including Business Development); Primary Clinical Representative in regulatory interactions.
- Lead cross-functional Clinical Development Team; provide disease area expertise; partner with KOLs and Worldwide Patient Safety on safety data.
- Evaluate strategic options vs Target Product Profile (TPP); develop asset risk management plans with Global Development Operations/Global Compliance.
- Set execution priorities; accountable for top-line data with CTP/CS/Statisticians.
Qualifications & Experience
- MD required; deep understanding of clinical principles (or equivalent therapy-area knowledge).
- At least 10 years relevant experience.
Key Competency Requirements
- Clinical development strategy/regulatory submission knowledge; strong external focus and relationship-building.
- Experience transitioning from first-in-human/POC to Phase II–III; lead/develop CTP group.
- People management track record; leadership in matrix teams.
Travel
- Domestic and international travel may be required.
Compensation & Benefits
- Compensation ranges (full-time): Cambridge Crossing $273,900–$331,907; Madison–Giralda NJ $244,560–$296,352; Princeton NJ $244,560–$296,352.
- Benefits include health coverage; wellbeing support; 401(k); disability/life/insurance options.
- Paid time off includes flexible time off or annual vacation plus holidays (varies by location/employee type).
Application instructions
- If the role doesn’t perfectly match your resume, you are encouraged to apply anyway.