Executive Director, Global Clinical Development (Neuroscience)
Bristol Myers Squibb
17 days ago
Remote friendly (Madison, NJ)
United States
Clinical Research and Development
Position Summary
- Set clinical development strategy for assets/indications.
- Directly supervise multiple Clinical Development Leads (who supervise Clinical Trial Physicians as applicable); oversee above-disease/indication strategy and cross-team governance.
- Partner with R&D and GDD for GT4/5 and POC transitions; provide insights into biology, translational elements, and benefit-risk assessments.
- Supervise development of differentiated Clinical Development Physicians for multiple transition assets; support work from Phase I expansion through registrational execution.
- Support portfolio activities (e.g., Protocol Review Committee, Business Development support, Quality/Compliance leadership).
- Report to Head of Clinical Development; deputize as required; serve on Therapeutic Area clinical development executive leadership team.
Key Responsibilities
- Create/communicate vision for innovative clinical development plans; supervise trial development, monitoring, analysis, and interpretation.
- Provide clinical components accountability for regulatory filings; contribute to disease/indication strategy with franchise portfolio view.
- Lead business development due diligence search/evaluation and advise strategic transactions.
- Chair required leadership forums; chair departmental staff meetings as needed.
- Build a franchise reputation that attracts innovators.
Leadership & Stakeholder Engagement
- Lead/develop up to ~50 Clinical Development professionals; recruit, retain, mentor; establish ethical, diverse, accountable, continuous-improvement culture; oversee budget/headcount.
- Work globally across Research, Development, Regulatory, Medical, Commercial; build external relationships with thought leaders, physicians, and patient advocacy groups; support seamless transition from early (FIH–POC) to late-stage (Phase II–III).
- Participate in governance ad hoc; chair PRC as needed; provide signature authority for key clinical documents (CSRs, health authority briefings/documents for filings, DMC charters, unblinding requests, and delegated clinical-accountable documents).
Qualifications
- MD (PhD or other high-level degree optional).
- 10+ years clinical trial/drug development/regulatory experience; strong scientific background.
- Experience designing/conducting Phase I/II/III trials; demonstrable success filing and prosecuting regulatory dossiers.
- Management experience leading professionals with clinical research experience.
- Deep biology/targets/translational science; extensive health authority experience.
- Experience with registrational and non-registrational trials; comfort in cross-functional matrix environment.
Preferred
- Global experience; oncology strategy across multiple geographies.
- Business development/licensing experience for in-licensing technical/franchise evaluation.
Travel
- Domestic and international travel may be required.
Compensation & Benefits (explicit)
- $340,870–$413,051 base range.
- Health coverage (medical/pharmacy/dental/vision), wellbeing programs, 401(k) and protection benefits.
- Paid Time Off: flexible time off or annual paid vacation depending on location/role; 11 paid national holidays (details vary by location); additional time off based on eligibility.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, you are encouraged to apply anyway.
- Set clinical development strategy for assets/indications.
- Directly supervise multiple Clinical Development Leads (who supervise Clinical Trial Physicians as applicable); oversee above-disease/indication strategy and cross-team governance.
- Partner with R&D and GDD for GT4/5 and POC transitions; provide insights into biology, translational elements, and benefit-risk assessments.
- Supervise development of differentiated Clinical Development Physicians for multiple transition assets; support work from Phase I expansion through registrational execution.
- Support portfolio activities (e.g., Protocol Review Committee, Business Development support, Quality/Compliance leadership).
- Report to Head of Clinical Development; deputize as required; serve on Therapeutic Area clinical development executive leadership team.
Key Responsibilities
- Create/communicate vision for innovative clinical development plans; supervise trial development, monitoring, analysis, and interpretation.
- Provide clinical components accountability for regulatory filings; contribute to disease/indication strategy with franchise portfolio view.
- Lead business development due diligence search/evaluation and advise strategic transactions.
- Chair required leadership forums; chair departmental staff meetings as needed.
- Build a franchise reputation that attracts innovators.
Leadership & Stakeholder Engagement
- Lead/develop up to ~50 Clinical Development professionals; recruit, retain, mentor; establish ethical, diverse, accountable, continuous-improvement culture; oversee budget/headcount.
- Work globally across Research, Development, Regulatory, Medical, Commercial; build external relationships with thought leaders, physicians, and patient advocacy groups; support seamless transition from early (FIH–POC) to late-stage (Phase II–III).
- Participate in governance ad hoc; chair PRC as needed; provide signature authority for key clinical documents (CSRs, health authority briefings/documents for filings, DMC charters, unblinding requests, and delegated clinical-accountable documents).
Qualifications
- MD (PhD or other high-level degree optional).
- 10+ years clinical trial/drug development/regulatory experience; strong scientific background.
- Experience designing/conducting Phase I/II/III trials; demonstrable success filing and prosecuting regulatory dossiers.
- Management experience leading professionals with clinical research experience.
- Deep biology/targets/translational science; extensive health authority experience.
- Experience with registrational and non-registrational trials; comfort in cross-functional matrix environment.
Preferred
- Global experience; oncology strategy across multiple geographies.
- Business development/licensing experience for in-licensing technical/franchise evaluation.
Travel
- Domestic and international travel may be required.
Compensation & Benefits (explicit)
- $340,870–$413,051 base range.
- Health coverage (medical/pharmacy/dental/vision), wellbeing programs, 401(k) and protection benefits.
- Paid Time Off: flexible time off or annual paid vacation depending on location/role; 11 paid national holidays (details vary by location); additional time off based on eligibility.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, you are encouraged to apply anyway.