Senior Director, Global Clinical Development, Neuroscience
Bristol Myers Squibb
4 days ago
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Position Summary
The Clinical Development Lead (CDL) sits within Clinical Development and serves as a matrix leader accountable for the overall clinical development plan for asset(s) in one or more indications/tumor types.
Key Responsibilities
- Lead, develop, motivate teams; direct management of Clinical Trial Physicians (CTPs).
- Own clinical accountability for the development team and indication strategy (registrational and non-registrational studies), aligning studies to label indications and regulatory/quality/medical/access goals.
- Accountable with Clinical Scientists (CS) for study design, execution, analyses, and clinical content for CSRs, regulatory reports, briefing books, and submission documents.
- Ensure GCP/compliance adherence; champion quality-focused mindset.
- Represent Clinical Development internally/externally as disease-area authority; serve as Primary Clinical Representative in regulatory interactions.
- Partner on safety data review with Worldwide Patient Safety; (co-)lead cross-functional Clinical Development Team.
- Provide disease-area expertise for integrated strategies; partner with KOLs.
- Evaluate strategic options vs. Target Product Profile (TPP); develop asset-level risk management plan with Global Development Operations/Global Compliance.
- Set executional priorities; provide top-line data leadership with CTP/CS/Statisticians.
Qualifications & Experience
- MD required; deep clinical principles knowledge (or equivalent therapy area knowledge).
- At least 10 years relevant experience.
Experience/Competencies (required attributes)
- Synthesize internal/external data to create clinical strategy; ensure viable registrational strategy.
- Demonstrated leadership in designing/executing multiple trials; strong people management/mentoring.
- Skills in clinical development strategy including regulatory submission clinical components.
Key Benefits (explicit)
- Health coverage (medical/pharmacy/dental/vision), wellbeing support (EAP), and 401(k), disability, life/accident insurance, identity theft, legal support.
- Paid time off (flexible time off for US exempt employees; annual paid vacation for certain roles).
Travel
- Domestic and international travel may be required.
The Clinical Development Lead (CDL) sits within Clinical Development and serves as a matrix leader accountable for the overall clinical development plan for asset(s) in one or more indications/tumor types.
Key Responsibilities
- Lead, develop, motivate teams; direct management of Clinical Trial Physicians (CTPs).
- Own clinical accountability for the development team and indication strategy (registrational and non-registrational studies), aligning studies to label indications and regulatory/quality/medical/access goals.
- Accountable with Clinical Scientists (CS) for study design, execution, analyses, and clinical content for CSRs, regulatory reports, briefing books, and submission documents.
- Ensure GCP/compliance adherence; champion quality-focused mindset.
- Represent Clinical Development internally/externally as disease-area authority; serve as Primary Clinical Representative in regulatory interactions.
- Partner on safety data review with Worldwide Patient Safety; (co-)lead cross-functional Clinical Development Team.
- Provide disease-area expertise for integrated strategies; partner with KOLs.
- Evaluate strategic options vs. Target Product Profile (TPP); develop asset-level risk management plan with Global Development Operations/Global Compliance.
- Set executional priorities; provide top-line data leadership with CTP/CS/Statisticians.
Qualifications & Experience
- MD required; deep clinical principles knowledge (or equivalent therapy area knowledge).
- At least 10 years relevant experience.
Experience/Competencies (required attributes)
- Synthesize internal/external data to create clinical strategy; ensure viable registrational strategy.
- Demonstrated leadership in designing/executing multiple trials; strong people management/mentoring.
- Skills in clinical development strategy including regulatory submission clinical components.
Key Benefits (explicit)
- Health coverage (medical/pharmacy/dental/vision), wellbeing support (EAP), and 401(k), disability, life/accident insurance, identity theft, legal support.
- Paid time off (flexible time off for US exempt employees; annual paid vacation for certain roles).
Travel
- Domestic and international travel may be required.