Global Safety Medical Director, Rare Disease
Core
Strategic safety leader for Rare Disease assets, accountable for benefit-risk profile, signal management, and safety governance in early clinical development (Phase 1b/2).
Role type
Senior IC physician safety leader (Global Safety Officer)
Builds
Innovative therapies for patients with rare diseases and high unmet medical need
Domain
Biotech / Rare Disease / Early Clinical Development
Required skills
Global safety strategy, signal detection and assessment, benefit-risk evaluation, safety governance, regulatory submission support, cross-functional leadership, protocol design, risk management plans
Preferred skills
Rare disease drug development, inflammatory/autoimmune/neuroinflammatory indications, biologics/gene therapies, early clinical development (FIH/dose escalation), cross-functional matrix leadership
Technologies
INDs, CTAs, BLAs, NDAs, MAAs, CRFs, Statistical Analysis Plans, Clinical Study Reports
Responsibilities
Lead global safety strategy for Phase 1b/2 programs; Partner with Clinical Development on dose-escalation and proof-of-concept decisions; Lead Safety Analysis Team (SAT) and Global Safety Team (GST); Review and interpret emerging safety data; Validate safety signals and lead risk evaluation; Prepare Risk Management Plans (RMPs) and aggregate safety reports; Support regulatory inspections and submissions.
Seniority
Senior, hands-on IC
