Medical Director
Core
Provide medical oversight and strategic leadership for Phase I–IV clinical trials and marketed product safety, ensuring regulatory compliance and patient safety.
Role type
Senior IC Medical Director (Clinical Trials & Safety)
Builds
Clinical trial services and safety dossiers for pharmaceutical and biotech clients
Domain
Clinical Research / Pharmacovigilance / Internal Medicine
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical licensure, Board certification in Internal Medicine, Clinical trial experience (CRO/Pharma/P.I.), Safety/Pharmacovigilance experience, Therapeutic expertise in Internal Medicine sub-specialties, Regulatory guideline knowledge (ICH-GCP, FDA, EMA), Medical judgment for adverse events, Leadership and mentoring, Strategic oversight, Risk management
Preferred skills
Experience with signal detection, Label updates, Dossier maintenance, Biostatistics, Data management, Clinical operations procedures
Technologies
Safety databases, Clinical trial management systems, Regulatory submission tools
Responsibilities
Provide medical oversight and accountability for safe conduct of clinical research activities; Serve as line manager for Principal and Sub-Investigators; Review and analyze serious adverse events, ICSR, and periodic safety reports; Monitor safety variables and discuss medical concerns with investigators; Manage signal detection and support risk management activities for marketed products.
Seniority
Senior, hands-on IC with leadership responsibilities