Senior Medical Director – Endocrinology

About the role

The Medical Director provides medical oversight of clinical trials, ensuring company SOPs, client directives, Good Clinical Practice and regulatory requirements are met. The role involves presenting at investigator and sponsor meetings, offering medical consultation to clients, investigators and project teams, and supporting business development activities.

Key responsibilities

• Manage all medical aspects of contracted tasks across the pharmaceutical product life‑cycle, ensuring compliance with regulations, ICH guidelines and client SOPs.
• Provide medical consultation to study teams, answer study‑related medical questions and deliver therapeutic and protocol training.
• Review and author safety and efficacy documents such as CSR, IND/NDA reports, ICSR, signal detection reports, periodic safety reports (PBRER, PSUR, DSUR), REMS, RMP and CTD modules.
• Monitor safety variables (adverse events, lab abnormalities, concomitant medications) and conduct medical review of serious adverse events and events of special interest.
• Engage with principal investigators and clients to discuss inclusion/exclusion criteria, medical concerns and protocol interpretations.
• Lead signal detection activities for marketed products, contribute to label updates and support dossier maintenance and risk‑management activities.

Required profile

• MD or equivalent degree; active medical licensure preferred.
• Combination of clinical experience (minimum 5 years for senior role) and industry experience in clinical trials or pharmacovigilance (4‑5 years).
• Demonstrated experience in safety/Pharmacovigilance, including review of adverse event data and preparation of regulatory safety reports.
• Strong decision‑making, analytical and communication skills, with ability to work independently and mentor junior staff.

Required skills

• Working knowledge of safety databases (e.g., Medra).
• Familiarity with FDA, ICH, EMA and GCP guidelines.
• Understanding of biostatistics, data management and clinical operations procedures.
• Proficiency in basic computer applications and ability to produce regulatory documentation.