Position Summary / Objective
- Serves as a primary source of medical accountability and oversight for multiple clinical trials
- Matrix management responsibilities across the internal and external network
- Manages Phase 1โPhase 3 studies, with demonstrated decision making capabilities
- Provides medical and scientific expertise to cross-functional BMS colleagues
Position Responsibilities
Medical Monitoring
- Contributes to and is a key member of a high performing Study Delivery Team (SDT) and may be a member of the Clinical Development Team (CDT)
- Leads medical data review of trial data, including eligibility review
- Holds responsibility for site interactions in partnership with the Clinical Scientist (CS) for medical questions and education (including safety management guidelines)
- Assesses key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives
- Collaborates with CS and provides medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations)
- Fulfills GCP and compliance obligations for clinical conduct and maintains all required training
Clinical Development Expertise & Strategy
- Designs and develops clinical plans and protocols in collaboration with the Clinical Development Lead to meet regulatory and disease strategy targets
- Provides oversight and medical accountability for a group of studies
- Leads benefit/risk analysis for clinical development protocols in a matrix environment with Clinical Scientists (CS)
- Partners with CS to support study execution (e.g., site activation, enrollment status, adjudication for protocol violations and deviations)
- Builds relationships with principal investigators and cultivates thought leaders for emerging science input
- Maintains in-depth disease area knowledge (etiology, natural history, diagnosis, treatment) via literature review and conference attendance
- Stays current on development and regulatory issues for competitive/relevant compounds
- Provides ongoing medical education with Clinical Scientists to support protocol-specific training and the study team/investigators
Health Authority Interactions & Publications
- Serves as medical point of expertise for Health Authority interactions and advisory board meetings
- Authors/drafts clinical content for CSRs, regulatory reports, briefing books, and submission documents (closure, clinical narratives, reporting, and study filing)
Experience Requirements
- 5+ years of industry experience and/or clinical trials experience required
Key Competency Requirements
- Ability to communicate clearly and lead scientific/clinical presentations
- Subspecialty training in applicable therapeutic area desired
- Expertise in the scientific method (statistical design, analysis, interpretation)
- Expertise in drug development process
- Expertise in components needed to execute clinical plans and protocols
- Strong leadership and teamwork skills
Travel Required
- Domestic and international travel may be required
Compensation Overview (if applicable)
- MadisonโGiralda, NJ: US $243,930โ$295,589
- Princeton, NJ: US $243,930โ$295,589
Benefits (explicitly listed)
- Health coverage (medical, pharmacy, dental, vision)
- Wellbeing support programs (BMS Well-Being Account, BMS Living Life Better, EAP)
- Financial wellbeing/protection (401(k), disability, life insurance, etc.)
- Paid Time Off (including flexible time off/vacation and national holidays per employee category)