Executive Director, Global Clinical Development (Neuroscience)
Bristol Myers Squibb
8 hours ago
Remote friendly (Madison, NJ)
United States
Clinical Research and Development
Position Summary
- Set the clinical development strategy for assets or indications.
- Directly supervise multiple Clinical Development Leads; Leads supervise individual Clinical Trial Physicians.
- Own above-disease/indication strategy; supervise Broad Clinical Development and Disease/Indication Strategy teams.
- Work with R&D and GDD to support GT4/5 and POC transitions, providing biology/translational insights and benefit-risk assessments.
- Supervise development of differentiated, strategic Clinical Development Physicians for multiple transition assets; support program work from Phase I expansion through registrational execution.
- Support portfolio activities aligned with Clinical Excellence (e.g., Protocol Review Committee, Business Development, Quality & Compliance leadership).
- Report to Head of Clinical Development; deputize as required; core member of Therapeutic Area clinical development executive leadership team.
Key Responsibilities (Strategy and Execution)
- Create and communicate a vision for innovative clinical development plans.
- Supervise trial development/monitoring/analysis/interpretation; accountable for clinical components of regulatory filings.
- Contribute to disease/indication strategy while ensuring franchise portfolio view.
- Provide strategic insights into development plans.
- Lead business development due diligence/search and evaluation efforts; advise strategic transactions group.
- Participate in leadership/clinical governance; chair staff meetings and PRC as needed.
Drug Development Experience
- Create strategies for programs beyond commercialization into lifecycle management.
Leadership and Matrix Management
- Lead and develop up to ~50 clinical development professionals; ensure scientific/technical excellence.
- Recruit, develop, retain talent; mentor staff.
- Establish ethical, inclusive culture; promote teamwork, peer review, coaching, accountability, integrity, and continuous improvement.
- Oversee team budget and headcount.
Stakeholder Engagement
- Global collaboration across Research, Development, Regulatory, Medical, Commercial and others; build external relationships with thought leaders/physicians/patient advocacy groups.
- Partner with Research and Early Development to ensure seamless transition from first-in-human/PoC to Phase II-III.
Governance/Signature Authority
- Ad hoc governance participation; PRC chair as needed.
- Signature authority for CSRs, Health Authority briefings, DMC charters, unblinding requests, Health Authority filing documents, and other delegated clinical-accountable documents.
Qualifications & Experience
- MD; PhD or other high-level degree optional.
- 10+ years clinical trial, drug development, and regulatory experience with strong scientific background.
- Demonstrated early-stage development expertise; Phase I/II/III trial design and execution; successful regulatory dossier filing and approval prosecution.
- Global experience (plus) for oncology strategy in multiple geographies.
- Experience with business development/licensing and evaluating in-licensing technical/franchise aspects.
Key Competency Requirements
- Track record managing complex clinical programs to regulatory submissions.
- Deep biology/targets/translational science understanding.
- Extensive health authority experience.
- Ability across registrational and non-registrational trials.
- Ability to lead matrix teams and execute people strategy; work effectively across Commercial, Medical, and R&D/Regulatory.
- Skilled at external engagement and speaking engagements; attract/develop/retain talent.
Travel
- Domestic and international travel may be required.
Compensation (if part of posting)
- $340,870–$413,051; additional incentive cash/stock may be available (based on eligibility).
- Set the clinical development strategy for assets or indications.
- Directly supervise multiple Clinical Development Leads; Leads supervise individual Clinical Trial Physicians.
- Own above-disease/indication strategy; supervise Broad Clinical Development and Disease/Indication Strategy teams.
- Work with R&D and GDD to support GT4/5 and POC transitions, providing biology/translational insights and benefit-risk assessments.
- Supervise development of differentiated, strategic Clinical Development Physicians for multiple transition assets; support program work from Phase I expansion through registrational execution.
- Support portfolio activities aligned with Clinical Excellence (e.g., Protocol Review Committee, Business Development, Quality & Compliance leadership).
- Report to Head of Clinical Development; deputize as required; core member of Therapeutic Area clinical development executive leadership team.
Key Responsibilities (Strategy and Execution)
- Create and communicate a vision for innovative clinical development plans.
- Supervise trial development/monitoring/analysis/interpretation; accountable for clinical components of regulatory filings.
- Contribute to disease/indication strategy while ensuring franchise portfolio view.
- Provide strategic insights into development plans.
- Lead business development due diligence/search and evaluation efforts; advise strategic transactions group.
- Participate in leadership/clinical governance; chair staff meetings and PRC as needed.
Drug Development Experience
- Create strategies for programs beyond commercialization into lifecycle management.
Leadership and Matrix Management
- Lead and develop up to ~50 clinical development professionals; ensure scientific/technical excellence.
- Recruit, develop, retain talent; mentor staff.
- Establish ethical, inclusive culture; promote teamwork, peer review, coaching, accountability, integrity, and continuous improvement.
- Oversee team budget and headcount.
Stakeholder Engagement
- Global collaboration across Research, Development, Regulatory, Medical, Commercial and others; build external relationships with thought leaders/physicians/patient advocacy groups.
- Partner with Research and Early Development to ensure seamless transition from first-in-human/PoC to Phase II-III.
Governance/Signature Authority
- Ad hoc governance participation; PRC chair as needed.
- Signature authority for CSRs, Health Authority briefings, DMC charters, unblinding requests, Health Authority filing documents, and other delegated clinical-accountable documents.
Qualifications & Experience
- MD; PhD or other high-level degree optional.
- 10+ years clinical trial, drug development, and regulatory experience with strong scientific background.
- Demonstrated early-stage development expertise; Phase I/II/III trial design and execution; successful regulatory dossier filing and approval prosecution.
- Global experience (plus) for oncology strategy in multiple geographies.
- Experience with business development/licensing and evaluating in-licensing technical/franchise aspects.
Key Competency Requirements
- Track record managing complex clinical programs to regulatory submissions.
- Deep biology/targets/translational science understanding.
- Extensive health authority experience.
- Ability across registrational and non-registrational trials.
- Ability to lead matrix teams and execute people strategy; work effectively across Commercial, Medical, and R&D/Regulatory.
- Skilled at external engagement and speaking engagements; attract/develop/retain talent.
Travel
- Domestic and international travel may be required.
Compensation (if part of posting)
- $340,870–$413,051; additional incentive cash/stock may be available (based on eligibility).