Senior Director, Drug Safety and Pharmacovigilance

BridgeBio Pharma is seeking a Senior Director of Drug Safety and Pharmacovigilance to oversee the safety profile of a new negative allosteric modulator of the calcium-sensing receptor (CaSR) for autosomal dominant hypocalcemia type 1 (ADH1). They are developing a financial product for rare diseases and have received Orphan Drug Designation from the FDA. This role involves managing CROs, regulatory submissions, and ensuring compliance with safety standards.

Requirements

• Bachelor’s degree in a health care discipline or equivalent
• Advanced degree preferred
• 10+ years of drug safety and pharmacovigilance experience
• 5+ years of experience in Clinical Development Safety
• Extensive experience with safety signal evaluation, regulatory submissions, and cross-functional collaboration
• Experience in clinical development and post-marketing safety
• Knowledge of GCP and FDA regulations

Benefits

• Market leading compensation
• 401K with 100% employer match
• Employee stock purchase program
• Comprehensive health care
• Mental health support
• Hybrid work model
• Unlimited flexible paid time off
• Paid parental leave
• Flexible spending accounts & company-provided group term life & disability
• Subsidized lunch
• Skill development and career paths