Senior Director, Global Clinical Development, Neuroscience
Bristol Myers Squibb
3 days ago
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Position Summary
The Clinical Development Lead sits within Clinical Development and drives clinical development strategy, design, execution, and interpretation of clinical trials.
Responsibilities
- Lead and manage matrix teams; develop, motivate and achieve results; direct management to Clinical Trial Physicians (CTPs)
- Serve as clinical point of accountability for the Development Team and overall clinical development plan for asset(s) in one or more indication(s)/tumor type(s)
- Ensure studies are aligned with target label indications and meet regulatory, quality, medical, and access goals
- Accountable for clinical contribution to indication strategy (registrational and non-registrational studies)
- Manage clinical trial physician(s): attract, develop, retain talent; ensure training and mentoring
- Partner with Clinical Scientists (CS) for design, execution, and analyses of each study; provide proactive collaboration
- Own clinical content for CSRs, regulatory reports, briefing books, and submission documents
- Ensure adherence to GCP and compliance obligations for clinical conduct
- Represent Clinical Development as consulted authority for disease area (including Business Development)
- Partner with Worldwide Patient Safety to review safety data
- (Co-)lead cross-functional Clinical Development Team; provide disease-area expertise into integrated strategies
- Collaborate with KOLs; serve as Primary Clinical Representative in Regulatory interactions
- Evaluate strategic options vs. Target Product Profile (TPP)
- Collaborate with Global Development Operations/Global Compliance to develop asset risk management plan; resolve Quality/CS issues and raise as needed
- Set execution priorities with CTP and CS; accountable for top-line data with support of CTP, CS, and Statisticians
Qualifications & Experience
- MD required; deep understanding of clinical principles of the area of interest or equivalent therapy area knowledge
- At least 10 years of relevant experience
Required Attributes/Skills
- Synthesize internal/external data into clinical strategy; ensure viable registrational strategy
- Lead hiring strategy; assess personnel needs
- Lead robust enterprise strategy across early, late, and post-marketing development
- Demonstrated sustained excellence as Clinical Trial Physician, Clinical Scientist, or equivalent
- Verifiable people management/mentoring in matrix teams
Key Competencies
- Clinical development strategy including regulatory submission clinical components
- External focus and relationship-building with thought leaders and external partners
- Partner with Early Development for first-in-human to proof-of-concept and transition to Phase II–III
- Ability to lead/develop CTP group for scientific/technical excellence
Travel
- Domestic and international travel may be required
The Clinical Development Lead sits within Clinical Development and drives clinical development strategy, design, execution, and interpretation of clinical trials.
Responsibilities
- Lead and manage matrix teams; develop, motivate and achieve results; direct management to Clinical Trial Physicians (CTPs)
- Serve as clinical point of accountability for the Development Team and overall clinical development plan for asset(s) in one or more indication(s)/tumor type(s)
- Ensure studies are aligned with target label indications and meet regulatory, quality, medical, and access goals
- Accountable for clinical contribution to indication strategy (registrational and non-registrational studies)
- Manage clinical trial physician(s): attract, develop, retain talent; ensure training and mentoring
- Partner with Clinical Scientists (CS) for design, execution, and analyses of each study; provide proactive collaboration
- Own clinical content for CSRs, regulatory reports, briefing books, and submission documents
- Ensure adherence to GCP and compliance obligations for clinical conduct
- Represent Clinical Development as consulted authority for disease area (including Business Development)
- Partner with Worldwide Patient Safety to review safety data
- (Co-)lead cross-functional Clinical Development Team; provide disease-area expertise into integrated strategies
- Collaborate with KOLs; serve as Primary Clinical Representative in Regulatory interactions
- Evaluate strategic options vs. Target Product Profile (TPP)
- Collaborate with Global Development Operations/Global Compliance to develop asset risk management plan; resolve Quality/CS issues and raise as needed
- Set execution priorities with CTP and CS; accountable for top-line data with support of CTP, CS, and Statisticians
Qualifications & Experience
- MD required; deep understanding of clinical principles of the area of interest or equivalent therapy area knowledge
- At least 10 years of relevant experience
Required Attributes/Skills
- Synthesize internal/external data into clinical strategy; ensure viable registrational strategy
- Lead hiring strategy; assess personnel needs
- Lead robust enterprise strategy across early, late, and post-marketing development
- Demonstrated sustained excellence as Clinical Trial Physician, Clinical Scientist, or equivalent
- Verifiable people management/mentoring in matrix teams
Key Competencies
- Clinical development strategy including regulatory submission clinical components
- External focus and relationship-building with thought leaders and external partners
- Partner with Early Development for first-in-human to proof-of-concept and transition to Phase II–III
- Ability to lead/develop CTP group for scientific/technical excellence
Travel
- Domestic and international travel may be required