Position Summary / Objective
- Primary source of medical accountability and oversight for clinical trials
- Matrix management responsibilities across internal and external network
- Manages Phase 1βPhase 3 studies with demonstrated decision-making
- Provides medical/scientific expertise to cross-functional colleagues
Responsibilities
Medical Monitoring
- Review medical data, including eligibility
- Manage site interactions with Clinical Scientist (CS) for medical questions/education and safety management guidelines
- Assess key safety-related serious adverse events; oversee safety narratives
- Collaborate with CS on protocol input (inclusion/exclusion and safety-related clinical considerations)
- Fulfill GCP/compliance obligations; maintain required training
Clinical Development Expertise & Strategy
- Design/develop clinical plans and protocols with strategic focus (asset/disease/science) to meet regulatory/disease targets
- Provide oversight/accountability for a group of studies; lead benefit/risk analysis
- Partner with CS to support study execution (site activation, enrollment status, adjudication of protocol violations/deviations)
- Build relationships with investigators/thought leaders; stay current on disease literature and competitive landscape
- Provide ongoing medical education to study team/investigators
Health Authority Interactions & Publications
- Contribute to Health Authority interactions/advisory boards
- Draft authorship of clinical content for CSRs and regulatory documents
Qualifications
- MD required (or x-US equivalent)
- 3+ years clinical trial experience (industry or academic)
Key Competencies/Skills (preferred)
- Clear scientific/clinical communication; subspecialty training desired
- Scientific method/statistical design, analysis, interpretation
- Knowledge of drug development and clinical plan/protocol execution; strong leadership/teamwork
Travel
- Domestic and international travel may be required.
Compensation/Benefits (as stated)
- Starting base ranges listed by location; additional incentive cash/stock may be available.
- Health, wellbeing, financial protection benefits; paid time off and other time-off programs per eligibility.
Application
- If role doesnβt perfectly match your resume, apply anyway.