Medical Director / Senior Medical Director – Dermatology

About the role

The Medical Director / Senior Medical Director provides medical oversight of dermatology clinical trials, ensuring compliance with SOPs, client directives, Good Clinical Practice and regulatory requirements. The role involves presenting at investigator and sponsor meetings, offering medical consultation, and supporting business development activities.

Key responsibilities

• Review and analyse serious adverse events, ICSR, periodic safety reports (PBRER, PSUR, DSUR) and other client deliverables such as labeling reconciliation, CTD modules, REMS, RMP and CSR.
• Monitor safety variables (adverse events, laboratory abnormalities, concomitant medication) and discuss medical concerns with investigators and clients.
• Manage signal detection activities, review aggregate safety reports, and support dossier maintenance and risk‑management activities for marketed products.
• Provide therapeutic and protocol training, mentor PV staff, and ensure delegated PV tasks are executed according to regulations and client SOPs.

Required profile

• MD or equivalent; active medical licensure preferred.
• Clinical experience in dermatology (≈2 years) combined with clinical‑trial experience (1‑2 years) or safety/pharmacovigilance experience (≈2 years).
• For senior level, a mix of clinical practice and industry experience in CROs, pharma companies or as a principal investigator.

Required skills

• Working knowledge of safety databases (e.g., Medra).
• Proficiency with basic computer applications.
• Understanding of FDA, ICH, EMA and GCP guidelines.
• Knowledge of biostatistics, data management and clinical‑operations procedures.