About this role

Serve as Medical Monitor for assigned clinical studies (Phase 1–3 and post marketing)
Conduct timely medical review of eligibility questions, protocol deviations, dosing decisions, stopping rules, and emergent safety issues
Support investigator engagement, including safety related medical guidance and training on risk mitigation measures
Lead or support clinical event review (AEs, SAEs, AESIs)
Provide medical input into informed consent forms, safety sections of protocols/IBs, and study level safety management plans
Contribute to ongoing benefit risk assessments by integrating clinical, nonclinical, and real world safety information
Participate in safety review meetings and provide medical input into risk mitigation and communication strategies
Ensure safety activities adhere to GxP, ICH guidelines, and applicable global regulations

MD or DO (or equivalent international medical degree)
8 years of experience in clinical development and/or pharmacovigilance
Strong understanding of global PV regulations and ICH guidelines
Demonstrated experience contributing to aggregate safety reporting (e.g., DSUR, PBRER/PSUR) and risk management planning (e.g., RMP)
Ability to collaborate effectively in a fast-paced environment and work with CROs/partners
Experience in early development and first in human studies

Senior Director, Medical Monitor – Safety Physician

Key skills