Senior Director, Clinical Safety Physician
Core
Provide strategic and hands-on medical leadership for clinical safety across investigational therapies targeting pulmonary fibrosis and serious respiratory diseases.
Role type
Senior Director, Clinical Safety Physician
Builds
Clinical-stage investigational therapies for pulmonary fibrosis and respiratory diseases
Domain
Biotechnology / Clinical Safety / Pulmonary Diseases
Required skills
Medical safety leadership, SAE/AESI review, causality assessment, signal detection, benefit-risk assessment, regulatory safety reporting, pharmacovigilance oversight, cross-functional safety governance, FDA/EMA interaction
Preferred skills
Board certification, Phase 2/3 clinical development experience, pulmonary disease background (ILD/IPF/PPF), rare disease experience, inhaled therapeutics experience, regulatory authority interaction
Technologies
MedDRA, ICH guidelines, GCP
Responsibilities
Conduct hands-on medical review of serious adverse events and safety narratives; Lead ongoing safety surveillance across Phase 1–3 clinical trials; Identify and evaluate emerging safety signals; Provide medical input into protocols and regulatory submissions; Lead cross-functional safety review meetings; Support Data Monitoring Committee activities; Provide medical oversight of outsourced pharmacovigilance activities; Interact with FDA and international health authorities.
Seniority
Senior Director, strategic leadership with hands-on medical involvement