Senior Director, Clinical Development Lead - Neuroscience
Bristol Myers Squibb
3 days ago
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Position Summary / Objective
- Matrix leader/manager responsible for overall clinical development plan for asset(s) in one or more indications/tumor types.
- Clinical point of accountability for the Development Team; ensures studies align with target label indications and meet regulatory, quality, medical, and access goals.
- Matrix leadership; direct manager to Clinical Trial Physicians (CTPs).
Position Responsibilities
- Accountable for clinical contribution to indication strategy (registrational and non-registrational), supported by CTPs and Clinical Scientists (CS).
- Manage clinical trial physician(s): attract, develop, retain talent; ensure training and mentoring.
- Partner with CTPs/CS for study design, execution, analyses, and proactively collaborate.
- Own clinical content for CSRs, regulatory reports, briefing books, and submission documents.
- Ensure adherence to GCP and compliance obligations.
- Represent Clinical Development as disease-area authority (incl. Business Development); provide clinical leadership and disease-area expertise.
- Collaborate on safety data review; (co-)lead cross-functional Clinical Development Team.
- Lead/assess strategic options vs. Target Product Profile (TPP); manage risk plan with Global Development Operations/Global Compliance; resolve Quality/CS issues.
- Accountable for top-line data with support of CTP, CS, and Statisticians.
Degree Requirements
- MD (preferred) or PhD/PharmD/health-science field with strong clinical principles; at least 9 years relevant experience.
Experience/Skills
- Proven leadership delivering multiple clinical trials; data synthesis into clinical strategy; viable registrational strategy.
- People management/mentoring success in matrix teams.
- Expertise in clinical development strategy and regulatory submissions; external relationship building; ability to lead/develop CTP group.
Travel
- Domestic and international travel may be required.
Compensation/Benefits (as listed)
- Compensation ranges vary by location.
- Benefits may include health coverage, wellbeing support, 401(k), disability/life insurance; paid time off (varies by site/role).
- Matrix leader/manager responsible for overall clinical development plan for asset(s) in one or more indications/tumor types.
- Clinical point of accountability for the Development Team; ensures studies align with target label indications and meet regulatory, quality, medical, and access goals.
- Matrix leadership; direct manager to Clinical Trial Physicians (CTPs).
Position Responsibilities
- Accountable for clinical contribution to indication strategy (registrational and non-registrational), supported by CTPs and Clinical Scientists (CS).
- Manage clinical trial physician(s): attract, develop, retain talent; ensure training and mentoring.
- Partner with CTPs/CS for study design, execution, analyses, and proactively collaborate.
- Own clinical content for CSRs, regulatory reports, briefing books, and submission documents.
- Ensure adherence to GCP and compliance obligations.
- Represent Clinical Development as disease-area authority (incl. Business Development); provide clinical leadership and disease-area expertise.
- Collaborate on safety data review; (co-)lead cross-functional Clinical Development Team.
- Lead/assess strategic options vs. Target Product Profile (TPP); manage risk plan with Global Development Operations/Global Compliance; resolve Quality/CS issues.
- Accountable for top-line data with support of CTP, CS, and Statisticians.
Degree Requirements
- MD (preferred) or PhD/PharmD/health-science field with strong clinical principles; at least 9 years relevant experience.
Experience/Skills
- Proven leadership delivering multiple clinical trials; data synthesis into clinical strategy; viable registrational strategy.
- People management/mentoring success in matrix teams.
- Expertise in clinical development strategy and regulatory submissions; external relationship building; ability to lead/develop CTP group.
Travel
- Domestic and international travel may be required.
Compensation/Benefits (as listed)
- Compensation ranges vary by location.
- Benefits may include health coverage, wellbeing support, 401(k), disability/life insurance; paid time off (varies by site/role).