Global Head of Clinical Safety
Core
Providing medical safety expertise for benefit/risk assessment of products in clinical development, specifically for the biologic Nemolizumab, including signal detection, risk management, and safety analyses.
Role type
Senior IC Global Head of Clinical Safety
Builds
Safety strategies and risk management plans for clinical development of biologics
Domain
Biopharmaceuticals / Dermatology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical safety expertise, signal detection, risk management, aggregate safety reporting, regulatory interactions, team leadership
Preferred skills
Additional degree in clinical pharmacology, pharmacovigilance, or epidemiology
Technologies
DSUR, PSUR, PBRER, RMP, IDMC
Responsibilities
Propose and recommend measures to minimize risks during clinical development; Partner with stakeholders to monitor safety profiles and validate signals; Take ownership of aggregate safety reports and Risk Management Plans; Provide input into safety modules for dossier submission; Contribute to investigator/KOL and IDMC meetings; Lead ongoing safety data review during clinical trials; Line manage a team of up to 5 direct reports.
Seniority
Senior, hands-on IC with line management
