Sr. Medical Director, Drug Safety

Mavericks are sought after for their experience in bringing together projects and promising research from academia to create life-changing medicines for rare disease patients. The organization focuses on Transthyretin Amyloid Cardiomyopathy (ATTR-CM) and values innovation, collaboration, and employee growth. They offer a remote opportunity within a dynamic environment.

Requirements

• Medical Degree
• 12+ years of drug safety and pharmacovigilance experience
• 2+ years of oversight management experience
• Extensive experience with all aspects of safety signal evaluation, regulatory submissions and data review
• Experience in clinical development and post-marketing safety
• Experience in regulatory submissions for NDAs, EU MAAs, and other countries’ Regulatory reviews
• Experience in managing a drug safety team or drug safety CRO
• Experience with data management, clinical sciences, medical monitors and QA
• Familiarity with GCP and FDA, Good Clinical Practices, and ICH regulations
• Proven ability to manage a drug safety team or drug safety CRO
• Experience in drug safety audits and agency inspections

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
• Career pathing
• Learning and Development programs