Senior Medical Director - Medical Monitoring (Clinical & Medical Affairs)

Senior Medical Director - Medical Monitoring (UT Clinical & Medical Affairs)

Responsibilities:
- Provide medical expertise, advice, and guidance to clinical development project teams and study personnel
- Maintain up-to-date knowledge of emerging therapies, clinical data, and the competitive landscape to inform study conduct and decision-making
- Provide medical support for routine and urgent medical inquiries from internal/external study teams and sites (including on-call support)
- Conduct medical monitoring activities for assigned clinical studies and ensure appropriate documentation of all related activities and communications
- Participate in review/approval of study protocols (study design, scheduled assessments, and subject safety)
- Review and approve patient information leaflets and informed consent form templates for assigned studies
- Communicate complex scientific/clinical information with external stakeholders regarding patient eligibility, treatment decisions, study assessments, and subject safety
- Draft/review/own study-specific medical monitoring plans
- Review study statistical analysis plans and draft data listings for medical consistency
- Provide clinical training for internal/external study team members and site personnel before and during study conduct
- Provide timely medical advice to resolve medical questions during study execution
- Review serious adverse events, adverse events, clinical laboratory data, and safety signal detection outputs; recommend actions to ensure subject safety
- Support DSMBs/DM committees and clinical trial steering committees when constituted
- Review/interpret/approve final study data and study reports
- Contribute to clinical and non-clinical data for high-quality publications
- Maintain relationships with external experts and support HCP interactions at conferences/symposia/advisory boards
- Support internal/external educational initiatives (medical education, data/guideline dissemination, scientific communications/training)
- Provide therapeutic knowledge support to the medical strategy team to address evidence gaps
- Work cross-functionally to provide strategic medical/scientific leadership and partnership
- Perform other duties as requested by line management

Minimum Requirements:
- MD with full registration with a medical licensing body (e.g., General Medical Council)
- 8+ years’ experience as a medical monitor in pharmaceutical product development within a clinical research organization or pharmaceutical company
- Physician/state licensure (MD - Physician - State Licensure)
- Ability to make independent study medical decisions with oversight/guidance; can act as primary MM on studies
- Competent end user of Microsoft Office (Word/Excel/Outlook/PowerPoint)
- Previous clinical research role experience in a clinical research organization or pharmaceutical company
- Ability to travel up to 20%

Job Location / Work Model:
- RTP, NC office; hybrid role requiring at least three days per week in the office (in-office requirements may increase).