Position Summary:
- Provide medical support for clinical drug development of assigned compound(s), including medical monitoring governance across portfolio programs and assisting with clinical development strategy and plans.
Job Responsibilities:
- Provide medical oversight for effective conduct of clinical trials, including:
- Medical monitoring on clinical development programs
- Collaborate with cross-functional areas on design/governance of clinical development plans and study protocols
- Monitor and review medical data for clinical trials and represent the sponsor in internal Safety Review Committees
- Engage with clinical investigators and study site personnel
- Analyze, present, and interpret data from clinical studies
- Participate in global clinical strategy and clinical development plan for assigned projects.
- Maintain current scientific knowledge via literature review and attendance at relevant scientific meetings.
- Collaborate with Clinical Team and Regulatory Affairs to support global Health Authorities, including preparation of clinical documents/sections and updates to key documentation (e.g., IB, DSUR).
- Represent the company in external engagement activities:
- Manage investigator interactions to address medical/scientific questions
- Assist in publishing data (abstract/poster, presentations, manuscripts)
- Collaborate with cross-functional teams (e.g., Pharmacovigilance, Regulatory Affairs, Clinical Operations, Data Management, Biostatistics).
Core Competencies / Skills:
- Study design, protocol development, and study conduct
- Excellent written and oral communication
- Knowledge of regulatory and compliance business processes in drug development
- Strong collaboration, decision-making, influence, execution, and risk management
Qualifications:
- MD (or equivalent); clinical experience in obesity and type 2 diabetes (preferred)
- 3β5+ years medical monitoring oversight and clinical drug development in pharma/biotech (including early/late-stage project design and implementation) or relevant clinical practice
- Experience preparing/submitting clinical trial documents and/or new drug applications (advantageous)