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 colleagues
Position Responsibilities
Medical Monitoring
- 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
- Partners with the Clinical Scientist (CS) on site interactions 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
- Fulfills GCP and compliance obligations for clinical conduct and maintains required training
Clinical Development Expertise & Strategy
- Designs and develops clinical plans and protocols with strategic focus 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
- Partners with CS to support execution of studies (e.g., site activation, enrollment status, adjudication for protocol violations/deviations)
- Identifies and builds relationships with principal investigators and cultivates thought leaders
- Maintains deep disease-area knowledge through conferences and literature review
- Stays abreast of development/regulatory issues for relevant compounds and the competitive landscape
- Provides ongoing medical education to support protocol-specific training
Health Authority Interactions & Publications
- Acts 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
Experience Requirements
- 5+ years of industry experience and/or clinical trials experience
Key Competency Requirements
- Ability to communicate clearly and lead presentations in scientific/clinical settings
- Subspecialty training in applicable therapeutic area desired
- Expertise in the scientific method (including statistical design, analysis, and interpretation)
- Expertise in the drug development process and in executing clinical plans/protocols
- Strong leadership skills; proven ability to lead and work effectively in a team environment
Travel Required
- Domestic and international travel may be required.