Medical Scientific Director

Responsibilities

• Oversee the day-to-day execution of BioMarin-sponsored and collaborative studies, ensuring consistency in approach, monitoring, and reporting.
• Execute evidence generation activities, including non-interventional, low-interventional, and interventional Phase IIIb/IV studies.
• Collaborate with Global Medical Leads, RWE, and HEOR to develop strategic study plans and dissemination strategies.
• Provide scientific input for the development of study concepts, protocols, statistical analysis plans, and data review plans.
• Lead the development of annual, interim, and periodic study reports and present results to internal and external stakeholders.
• Coordinate Medical Affairs input for regulatory submissions and responses to regulatory agencies, IRB, and Ethics Committee queries.
• Ensure adequate medical monitoring oversight, including subject eligibility, safety data quality, and inspection readiness.

Requirements

• PharmD, PhD, or MD with at least 5 years of experience in observational and Phase IIIb/IV studies within Clinical Development or Medical Affairs.
• Alternatively, an MS or MPH with 10+ years of similar experience.
• Proven experience responding to regulatory agency and IRB/Ethics Committee questions regarding study designs and protocol conduct.
• Advanced knowledge of the clinical research process and Good Clinical/Pharmacoepidemiology Practice standards.
• Strong scientific writing skills and experience in document development.
• Ability to work effectively in a cross-functional matrix environment.

About the Company

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions. Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. We are dedicated to delivering innovative treatments for patients and families around the world facing rare genetic conditions.