Position Summary / Objective
- Primary source of medical accountability and oversight for clinical trials
- Matrix management across internal/external network
- Manage Phase 1βPhase 3 studies with demonstrated decision-making
- Provide medical and scientific expertise to cross-functional teams
Position Responsibilities
Medical Monitoring
- Contribute to Study Delivery Team (SDT) and may join Clinical Development Team (CDT)
- Review medical trial data, including eligibility review
- Partner with Clinical Scientist (CS) for site interactions, medical questions, education, and safety management guidelines
- Assess key safety-related serious adverse events; oversee safety narratives
- Collaborate with CS on protocols and provide medical strategic oversight (e.g., inclusion/exclusion and safety considerations)
- Fulfill GCP/compliance obligations; maintain required training
Clinical Development Expertise & Strategy
- Design/develop clinical plans and protocols with strategic focus aligned to regulatory and disease strategy targets
- Provide oversight/accountability for a group of studies; lead benefit/risk analysis
- Partner with CS to support study execution (e.g., site activation, enrollment status, adjudication of protocol violations/deviations)
- Build relationships with principal investigators and thought leaders; maintain therapeutic area scientific reputation
- Provide ongoing medical education supporting protocol-specific training
Health Authority Interactions & Publications
- Contribute to Health Authority interactions/advisory boards
- Draft clinical content for CSRs, regulatory reports, briefing books, and submission documents
Experience Requirements
- 3+ years industry and/or clinical trials experience
Key Competencies (required/preferred)
- Clear scientific/clinical communication and presentation
- Subspecialty training in applicable therapeutic area desired
- Scientific method expertise (including statistical design, analysis, interpretation)
- Knowledge of drug development process and clinical plan/protocol execution
- Strong leadership and teamwork
Travel
- Domestic and international travel may be required
Compensation / Benefits (as stated)
- Starting base ranges vary by location; additional incentive cash/stock may be available
- Health coverage; wellbeing support; financial protection (e.g., 401(k), disability, life, insurance)
Work-life Benefits
- Paid Time Off (includes flexible time off for US exempt roles and annual vacation/holidays for specified groups)
Application instructions
- If you donβt perfectly match the resume, apply anyway.