Medical Director / Senior Medical Director – Psychiatry

About the role

The Medical Director / Senior Medical Director, Psychiatry provides medical oversight of 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, supporting business development, and reviewing serious adverse events.

Key responsibilities

• Ensure delegated medical monitor tasks are executed correctly and adhere to ICH, FDA, EMA and GCP guidelines.
• Monitor safety variables (adverse events, lab abnormalities, patient status changes) and provide medical review of serious and special‑interest events.
• Communicate medical concerns with principal investigators and clients, interpreting inclusion/exclusion criteria and protocol restrictions.
• Deliver therapeutic and protocol training to study teams as required.

Required profile

• MD or equivalent; active medical licensure preferred but not required.
• Clinical experience in psychiatry (minimum 2 years) with residency or fellowship training.
• For Senior level: 1‑2 years of relevant CRO or pharmaceutical industry experience, preferably in clinical development or medical monitoring.
• Strong decision‑making, analytical and communication skills; ability to work independently and mentor staff.

Required skills

• Working knowledge of MedDRA safety database.
• Proficiency with basic computer applications.
• Familiarity with FDA, ICH, EMA and GCP guidelines.
• Understanding of biostatistics, data management and clinical operations procedures.

What we offer

• Competitive remuneration with an annual incentive bonus.
• Comprehensive healthcare and employee benefits.
• Opportunities for career development within an innovative, global organization.
• Collaborative culture that values integrity, intensity, involvement and innovation.