Executive Director, Global Clinical Development (Neuroscience)
Bristol Myers Squibb
18 days ago
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Position Summary
- Set clinical development strategy for assets/indications.
- Supervise multiple Clinical Development Leads and Clinical Trial Physicians; oversee above-disease/indication strategy across broad and disease/indication strategy teams.
- Partner with Research & Early Development and GDD to support GT4/5 and POC transitions, providing biology/translational insights and benefit-risk assessments.
- Supervise development of Clinical Development Physicians for transition assets; support programs from Phase I expansion through registrational execution.
- Support portfolio activities (e.g., Protocol Review Committee), Business Development due diligence, and Quality/Compliance leadership.
- Report to Head of Clinical Development; deputize as required; core member of Therapeutic Area clinical development executive leadership.
Key Responsibilities (Strategy/Execution)
- Create/communicate vision for innovative clinical development plans; supervise clinical trial development, monitoring, analysis, interpretation.
- Ensure accountability for clinical components of regulatory filings.
- Provide strategic insights; chair leadership forums/staff meetings as required.
- Lead search/evaluation for business development due diligence/licensing technical evaluation.
Leadership/Matrix Management
- Lead and develop a matrix team (up to ~50 direct/indirect); recruit/develop/retain talent; mentoring; foster ethical, diverse, accountable, continuous-improvement culture; oversee budget/headcount.
Stakeholders/Governance
- Collaborate globally across Research, Development, Regulatory, Medical, Commercial; build external relationships.
- Partner from first-in-human/PoC through seamless transition to Phase II-III.
- Ad hoc governance participation; PRC chair ad hoc; signature authority for CSRs, Health Authority briefings, DMC charters, unblinding requests, Health Authority filing documents, and other delegated clinical documents.
Qualifications & Requirements
- MD; PhD or other high-level degree optional.
- 10+ years clinical trials/drug development/regulatory experience; strong science background.
- Experience designing Phase I/II/III trials; demonstrable success filing and prosecuting regulatory dossiers.
- Management experience with clinical research professionals.
- Deep biology/targets/translational science knowledge; extensive health authority experience.
- Experience across registrational/non-registrational trials; matrix leadership.
- Strong cross-functional and external speaker/engagement skills.
Travel: Domestic and international travel may be required.
Compensation/Benefits (if applicable)
- Paid Time Off (e.g., flexible time off/11 national holidays; or 160 hours annual vacation + 11 holidays + 3 optional holidays depending on location/role).
- Health, wellbeing, and financial protection benefits (medical/pharmacy/dental/vision; wellbeing programs; 401(k), disability, life/accident insurance, etc.).
Application Instructions
- If the role doesn’t perfectly match your resume, apply anyway.
- Set clinical development strategy for assets/indications.
- Supervise multiple Clinical Development Leads and Clinical Trial Physicians; oversee above-disease/indication strategy across broad and disease/indication strategy teams.
- Partner with Research & Early Development and GDD to support GT4/5 and POC transitions, providing biology/translational insights and benefit-risk assessments.
- Supervise development of Clinical Development Physicians for transition assets; support programs from Phase I expansion through registrational execution.
- Support portfolio activities (e.g., Protocol Review Committee), Business Development due diligence, and Quality/Compliance leadership.
- Report to Head of Clinical Development; deputize as required; core member of Therapeutic Area clinical development executive leadership.
Key Responsibilities (Strategy/Execution)
- Create/communicate vision for innovative clinical development plans; supervise clinical trial development, monitoring, analysis, interpretation.
- Ensure accountability for clinical components of regulatory filings.
- Provide strategic insights; chair leadership forums/staff meetings as required.
- Lead search/evaluation for business development due diligence/licensing technical evaluation.
Leadership/Matrix Management
- Lead and develop a matrix team (up to ~50 direct/indirect); recruit/develop/retain talent; mentoring; foster ethical, diverse, accountable, continuous-improvement culture; oversee budget/headcount.
Stakeholders/Governance
- Collaborate globally across Research, Development, Regulatory, Medical, Commercial; build external relationships.
- Partner from first-in-human/PoC through seamless transition to Phase II-III.
- Ad hoc governance participation; PRC chair ad hoc; signature authority for CSRs, Health Authority briefings, DMC charters, unblinding requests, Health Authority filing documents, and other delegated clinical documents.
Qualifications & Requirements
- MD; PhD or other high-level degree optional.
- 10+ years clinical trials/drug development/regulatory experience; strong science background.
- Experience designing Phase I/II/III trials; demonstrable success filing and prosecuting regulatory dossiers.
- Management experience with clinical research professionals.
- Deep biology/targets/translational science knowledge; extensive health authority experience.
- Experience across registrational/non-registrational trials; matrix leadership.
- Strong cross-functional and external speaker/engagement skills.
Travel: Domestic and international travel may be required.
Compensation/Benefits (if applicable)
- Paid Time Off (e.g., flexible time off/11 national holidays; or 160 hours annual vacation + 11 holidays + 3 optional holidays depending on location/role).
- Health, wellbeing, and financial protection benefits (medical/pharmacy/dental/vision; wellbeing programs; 401(k), disability, life/accident insurance, etc.).
Application Instructions
- If the role doesn’t perfectly match your resume, apply anyway.