Medical Scientific Director

Job Summary

Accountable for the oversight of BioMarin-sponsored and collaborative studies, the remote Medical Scientific Director will manage evidence generation activities, collaborate with cross-functional teams, and ensure the successful implementation of study strategies in a full-time capacity.

Key Responsibilities

• Executes evidence generation activities to fill priority evidence gaps identified in product Integrated Evidence Plans (IEPs)
• Collaborates with Global and Country Medical Leads to develop strategic study pull-through and dissemination plans
• Leads the development of study reports and coordinates Medical Affairs input for regulatory submissions and queries

Required Qualifications

• PharmD/PhD/MD with at least 5 years of experience in observational and Phase IIIb/IV studies, or MS/MPH with 10+ years of similar experience
• Proven track record of delivering high-quality observational and Phase IIIb/IV studies
• Experience responding to regulatory agency and IRB/Ethics Committee questions regarding study designs
• Advanced knowledge of the clinical research process and Good Clinical Practice standards
• Strong scientific writing and document development skills