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About the Role
Bristol Myers Squibb is a purpose-driven organization dedicated to discovering, developing, and delivering innovative medicines to prevail over serious diseases. We offer meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, and flexibility. This role is critical in transforming the lives of patients and the careers of those who do it.
Responsibilities
- Serves as a primary source of medical accountability and oversight for multiple clinical trials.
- Manages Phase 1 – Phase 3 studies, with demonstrated decision making capabilities.
- Provides medical and scientific expertise to cross-functional BMS colleagues.
- 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.
- Holds responsibility for assessment of key safety-related serious adverse events and oversees safety narratives.
- Leads collaboration with CS and inputs into protocols, providing medical strategic oversight in protocol development.
- Fulfills GCP and compliance obligations for clinical conduct and maintains all required training.
- Designs and develops clinical plans and protocols with a strong strategic focus.
- Provides oversight and medical accountability for a group of studies.
- Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment.
- Partners with CS to support executional delivery of studies.
- Identifies and builds relationships with principal investigators and cultivates thought leaders.
- Maintains a strong medical/scientific reputation within the disease area.
- Keeps abreast of development and regulatory issues related to other competitive or relevant compounds.
- Provides ongoing medical education in partnership with collaborating Clinical Scientists.
- Serves as medical point of expertise in key Health Authority interactions and advisory board meetings.
- Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents.
Requirements
- 5 or more years of clinical trial experience, either in industry or academic setting is required.
- Ability to communicate information clearly and lead presentations in scientific and clinical settings.
- Expertise in the scientific method to test hypotheses, including statistical design, analysis, and interpretation.
- Expertise in drug development process.
- Expertise in the components needed to execute an effective clinical plan and protocols.
- Strong leadership skills with proven ability to lead and work effectively in a team environment.
Skills
- Medical Monitoring
- Clinical Development Expertise & Strategy
- Health Authority Interactions & Publications
- Communication
- Leadership
Location
- Domestic
- International
Work Type
- Site-essential
- Site-by-design
- Field-based
- Remote-by-design
Experience Level
- 5 or more years of clinical trial experience
Education Level
- MD required
Benefits
- Comprehensive benefits
About the Company
- Bristol Myers Squibb is a purpose-driven organization dedicated to discovering, developing, and delivering innovative medicines to prevail over serious diseases.
- We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits.
- This is work that transforms the lives of patients, and the careers of those who do it.
Equal Opportunity
- BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.
- Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.
- Bristol Myers Squibb is Disability Confident – Employer
- BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.