About this role
Job title: Medical Director - CVM
About the Role Medical Director - CVM at Roche provides scientific and medical leadership to develop and execute the Clinical Development Plan (CDP) for assigned molecule(s) or indication(s). The role requires an MD with therapeutic expertise in metabolism, obesity, and diabetes, strong data analysis, and experience in clinical trial development, with global travel up to 30%.
What You'll Do
- Participates in development of the CD plan for assigned molecule(s)/indication(s)
- Gathers and analyzes data to create the CD plan
- Works with CST members and sub-teams to develop CD plan components (analytics/data strategy, KOL development, publications strategy, etc.)
- Develops budget/resource requirements with CST and other teams
- Stays current on internal and external developments affecting the disease area
- Participates in competitive intelligence or market assessment activities
- Maintains high standards of scientific and clinical knowledge in the therapeutic areas
- Collaborates with investigators, clinicians, scientists, KOLs, and internal groups across PD, research, BD, commercial, legal
- May participate in early development/Phase I meetings for clinical science input
- Reviews and provides input for Phase I/II protocols
- Supports internal partners in transitioning new drugs/indications into MA studies with CD input for MA study protocols
- Participates in design, development, and execution of clinical studies
- Creates product safety profiles and clinical sections of investigator brochures, presentations and materials
- Guides external investigators and sites in study conduct
- Develops and implements communications strategies for ongoing and concluded studies (investigator meetings, KOL interactions, advisory boards, congresses, publications)
- Delivers key presentations to communicate CD perspective and updates
- Presents at advisory boards and external forums representing Roche
- Collaborates on study analytics and data management plans
- Monitors medical/safety data and study progress; identifies and addresses issues
- Ensures timely interim reporting and close-out activities including data retention
What We're Looking For
- MD required
- Therapeutic knowledge within metabolism, obesity, and diabetes with relevant clinical, scientific, and clinical trial/development experience
- Experience working with data analysis, interpretation, and clinical relevance
- Experience publishing results of a scientific study in peer-reviewed journals
- Knowledge of GCP, ICH, FDA, EMA and other guidelines
- 2+ years post-graduate academic or clinical experience
- Ability to travel up to 30%
- Ethics, attention to detail, business acumen, organization, interpersonal, writing, presentation, negotiation, decision making, and teamwork
Nice to Have
- Academic/teaching background is a plus
Compensation & Benefits
- Not disclosed in posting