We are looking for a Sr. Director/Safety Scientist to oversee all aspects of a product's safety profile from clinical development to post-approval safety surveillance. The ideal candidate will have a strong background in drug safety and pharmacovigilance, including experience with regulatory submissions, safety signal evaluation, and data analysis.
Requirements
• Bachelor's degree in a healthcare discipline or equivalent
• Minimum of ten years of drug safety and pharmacovigilance experience
• Experience with all aspects of safety signal evaluation, including data review and analysis, cross-functional collaboration, authoring regulatory correspondence, and safety label updates
• Experience in both clinical development and post-marketing safety
• Regulatory submissions for NDAs, EU MAAs, and other global regulatory reviews
• Experience in drug safety audits and regulatory agency inspections
• Intimate knowledge of GCP and strong working knowledge of FDA regulations, ICH guidelines, and global pharmacovigilance requirements
Benefits
• Market-leading compensation
• 401(k) with 100% employer match on the first 3% and 50% match on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with a $2,500 award for hired referrals
• Comprehensive health coverage with 100% of premiums covered for employees and dependents
• Mental health support via Spring Health (6 therapy sessions and 6 coaching sessions)
• Hybrid work model with flexibility in where and how work is performed
• Unlimited flexible paid time off
• Paid parental leave: 4 months for birthing parents and 2 months for non-birthing parents
• Flexible spending accounts and company-provided group term life and disability insurance
• Subsidized lunches via Forkable on in-office days
• Opportunities for growth from discovery through late-stage development and FDA pipelines
• Career pathing through regular feedback, professional development programs, and continuous education via LinkedIn Learning, LifeLabs, Spring Health, and BetterUp Coaching
• Recognition of strong performance through financial rewards, peer recognition, and advancement opportunities