Executive Director, Global Clinical Development (Neuroscience)
Bristol Myers Squibb
5 months 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; partner with R&ED and GDD for GT4/5 and POC transitions (biology, translational elements, benefit/risk).
- Supervise development of Clinical Development Physicians for transition assets; support Phase I expansion through registrational execution.
- Support portfolio activities (Protocol Review Committee, Business Development, Quality/Compliance leadership).
Key Responsibilities
- Create and communicate vision for innovative clinical development plans.
- Supervise trial development, monitoring, analysis/interpretation; accountable for clinical components of regulatory filings.
- Provide strategic insights; lead business development due diligence evaluation.
- Chair leadership forums/staff meetings as required.
- Oversee franchise reputation-building.
- Create strategy to extend programs beyond commercialization into lifecycle management.
Leadership & Matrix Management
- Lead/develop a therapeutic-area focused team (up to ~50 direct/indirect); recruit, retain, mentor talent.
- Establish ethical, team-based culture; value diversity of thought, coaching, accountability, integrity, process excellence.
- Oversee team budget and headcount.
Stakeholder Engagement
- Global collaboration across Research, Development, Regulatory, Medical, Commercial; build external relationships; recognized as expert.
Governance/Signature Authority
- Ad hoc governance participation; PRC Chair ad hoc.
- Signature authority for: CSRs, Health Authority Briefings, DMC Charters, unblinding requests, and Health Authority documents for filings (and delegated clinical documents).
Qualifications & Experience
- MD required (PhD/other high-level degree optional).
- 10+ years clinical trial/drug development/regulatory experience; strong scientific background.
- Experience designing Phase I/II/III trials; demonstrable regulatory dossier filing/prosecution success.
- Management experience preferred.
Key Competencies
- Proven track record delivering regulatory submissions; deep biology/targets/translational science; health authority experience.
- Ability to manage registrational and non-registrational trials; lead matrix teams.
Travel Required
- Domestic and international travel may be required.
Benefits
- Health coverage (medical, pharmacy, dental, vision); wellbeing programs; 401(k); disability/life insurance and related protections.
- Paid time off: flexible time off (unlimited, with manager approval) and 11 paid national holidays (eligibility varies by location).
Compensation
- $340,870–$413,051 (FTE); additional incentive cash/stock may be available.
Application Instruction
- If intrigued but not a perfect resume match, encouraged to apply anyway.
- Set clinical development strategy for assets/indications; supervise multiple Clinical Development Leads and Clinical Trial Physicians.
- Oversee above-disease/indication strategy; partner with R&ED and GDD for GT4/5 and POC transitions (biology, translational elements, benefit/risk).
- Supervise development of Clinical Development Physicians for transition assets; support Phase I expansion through registrational execution.
- Support portfolio activities (Protocol Review Committee, Business Development, Quality/Compliance leadership).
Key Responsibilities
- Create and communicate vision for innovative clinical development plans.
- Supervise trial development, monitoring, analysis/interpretation; accountable for clinical components of regulatory filings.
- Provide strategic insights; lead business development due diligence evaluation.
- Chair leadership forums/staff meetings as required.
- Oversee franchise reputation-building.
- Create strategy to extend programs beyond commercialization into lifecycle management.
Leadership & Matrix Management
- Lead/develop a therapeutic-area focused team (up to ~50 direct/indirect); recruit, retain, mentor talent.
- Establish ethical, team-based culture; value diversity of thought, coaching, accountability, integrity, process excellence.
- Oversee team budget and headcount.
Stakeholder Engagement
- Global collaboration across Research, Development, Regulatory, Medical, Commercial; build external relationships; recognized as expert.
Governance/Signature Authority
- Ad hoc governance participation; PRC Chair ad hoc.
- Signature authority for: CSRs, Health Authority Briefings, DMC Charters, unblinding requests, and Health Authority documents for filings (and delegated clinical documents).
Qualifications & Experience
- MD required (PhD/other high-level degree optional).
- 10+ years clinical trial/drug development/regulatory experience; strong scientific background.
- Experience designing Phase I/II/III trials; demonstrable regulatory dossier filing/prosecution success.
- Management experience preferred.
Key Competencies
- Proven track record delivering regulatory submissions; deep biology/targets/translational science; health authority experience.
- Ability to manage registrational and non-registrational trials; lead matrix teams.
Travel Required
- Domestic and international travel may be required.
Benefits
- Health coverage (medical, pharmacy, dental, vision); wellbeing programs; 401(k); disability/life insurance and related protections.
- Paid time off: flexible time off (unlimited, with manager approval) and 11 paid national holidays (eligibility varies by location).
Compensation
- $340,870–$413,051 (FTE); additional incentive cash/stock may be available.
Application Instruction
- If intrigued but not a perfect resume match, encouraged to apply anyway.