Senior Medical Director Clinical Development - Prostate Cancer
Bristol Myers Squibb
July 02, 2026
Remote
United States
Clinical Research and Development
Responsibilities:
- Develop and execute clinical development strategy for prostate cancer assets (IND to Phase 3 registrational studies).
- Lead clinical development plans across the full development lifecycle; grow and manage the prostate cancer clinical team as needed.
- Partner with research and translational medicine to inform clinical-stage assets and pipeline molecules; participate in BD and due diligence.
- Work with BMS oncology leaders to develop combination strategies and support prostate disease area strategies.
- Provide medical direction and lead execution of early/late clinical development plans, including IND preparation, regulatory interactions, Phase 1–3 trial design/execution, and medical monitoring.
- Lead cross-functional study teams for design, implementation, monitoring, analysis, and reporting.
- Author protocols, investigator brochures, clinical study reports, and other clinical/regulatory documents.
- Conduct investigator meetings; lead site qualification and initiation.
- Deploy drug development strategic and contingency plans; meet milestones and budgets.
- Translate research/nonclinical findings into clinical opportunities; oversee Data Review and Independent Data Monitoring Committees.
- Ensure clinical trials comply with relevant ethical/industry guidelines.
- Lead regulatory interactions as needed (briefing documents; health authority meetings) and oversee regulatory submissions.
- Recruit, build, and mentor clinical scientists/medical directors.
- Leverage AI to drive program/portfolio/function performance; travel ~30%.
Qualifications:
- MD (or equivalent) with oncology sub-specialty training and 10+ years oncology solid-tumor clinical development in pharma/biotech/academia (radiopharmaceutical preferred, not required).
- Drug development experience in prostate cancer (required).
Skills/Requirements:
- Patient-focused, collaborative, “can do” leadership through influence.
- Strong written/oral communication and presentation skills.
- Strategic, analytical, critical thinking.
- Experience with NDA/MAA preparation/submission and complex global health authority interactions.
- Full protocol conduct experience (early and late phase), including writing, start-up, execution, analysis, and reporting.
- Experience working with investigative sites (PI, sub-investigators, coordinators).
- Knowledge of clinical research, regulated environments, and SOP adherence; strong GCP/ICH understanding.
Benefits:
- Health coverage (medical, pharmacy, dental, vision); wellbeing support; 401(k); disability and life insurance; and paid time off (including flexible time off or vacation/holidays depending on location), plus additional eligibility-based time off.
Application instructions:
- If the role doesn’t perfectly match your resume, apply anyway.
- Develop and execute clinical development strategy for prostate cancer assets (IND to Phase 3 registrational studies).
- Lead clinical development plans across the full development lifecycle; grow and manage the prostate cancer clinical team as needed.
- Partner with research and translational medicine to inform clinical-stage assets and pipeline molecules; participate in BD and due diligence.
- Work with BMS oncology leaders to develop combination strategies and support prostate disease area strategies.
- Provide medical direction and lead execution of early/late clinical development plans, including IND preparation, regulatory interactions, Phase 1–3 trial design/execution, and medical monitoring.
- Lead cross-functional study teams for design, implementation, monitoring, analysis, and reporting.
- Author protocols, investigator brochures, clinical study reports, and other clinical/regulatory documents.
- Conduct investigator meetings; lead site qualification and initiation.
- Deploy drug development strategic and contingency plans; meet milestones and budgets.
- Translate research/nonclinical findings into clinical opportunities; oversee Data Review and Independent Data Monitoring Committees.
- Ensure clinical trials comply with relevant ethical/industry guidelines.
- Lead regulatory interactions as needed (briefing documents; health authority meetings) and oversee regulatory submissions.
- Recruit, build, and mentor clinical scientists/medical directors.
- Leverage AI to drive program/portfolio/function performance; travel ~30%.
Qualifications:
- MD (or equivalent) with oncology sub-specialty training and 10+ years oncology solid-tumor clinical development in pharma/biotech/academia (radiopharmaceutical preferred, not required).
- Drug development experience in prostate cancer (required).
Skills/Requirements:
- Patient-focused, collaborative, “can do” leadership through influence.
- Strong written/oral communication and presentation skills.
- Strategic, analytical, critical thinking.
- Experience with NDA/MAA preparation/submission and complex global health authority interactions.
- Full protocol conduct experience (early and late phase), including writing, start-up, execution, analysis, and reporting.
- Experience working with investigative sites (PI, sub-investigators, coordinators).
- Knowledge of clinical research, regulated environments, and SOP adherence; strong GCP/ICH understanding.
Benefits:
- Health coverage (medical, pharmacy, dental, vision); wellbeing support; 401(k); disability and life insurance; and paid time off (including flexible time off or vacation/holidays depending on location), plus additional eligibility-based time off.
Application instructions:
- If the role doesn’t perfectly match your resume, apply anyway.