Medical Scientific Director (Associate Director)

Job title: Medical Scientific Director (Associate Director)

About the Role The Medical Scientific Director (Associate Director) is accountable for the day-to-day oversight of BioMarin-sponsored and collaborative studies across a therapeutic area. The role partners with Real World Evidence (RWE)/Epidemiology, Global Medical Leads, Data Sciences and Global Study Operations to develop practical study strategies and ensure optimal hands-on study operations and execution support for Medical Affairs–led studies from cross‑functional partners.

The Medical Scientific Director is part of the Integrated Evidence function, comprising subject matter experts in evidence planning, observational study design and data interpretation, driving excellence in evidence planning and novel study designs to generate robust evidence and inform medical practice and long‑term safety and effectiveness of BioMarin products.

What You'll Do

• Study Strategy and Implementation: Execute evidence generation activities (non-interventional, low-interventional and interventional Phase IIIb/IV studies) to fill priority evidence gaps identified in product Integrated Evidence Plans (IEPs).
• Collaborate with Global and Country Medical Leads, RWE Lead, and HEOR to understand global and local needs and develop strategic study pull-through and dissemination plans.
• Work with operational strategic partners to ensure successful implementation of GMAF‑led studies; identify issues, lead complex solutions, and escalate as appropriate.
• Provide scientific input into study concepts, protocols and amendments, statistical analysis plans, data review plans, and responses to regulatory questions.
• Lead the development of annual, interim and periodic study reports, coordinating SME input, data interpretation and presentation; ensure regulatory questions are addressed where relevant.
• Design secondary data analysis plans using BioMarin clinical and real-world data to support program strategy.
• Ensure adequate medical monitoring oversight, including eligibility, safety and data quality, ICF/CRF approvals, coding, and inspection readiness.
• Present results to internal and external stakeholders, including scientific conferences.
• Coordinate Medical Affairs input for regulatory submissions, responses to queries, IRB/Ethics questions, and program inspections/audits.
• Participate in efficiency initiatives to improve study implementation.

What We're Looking For

• PharmacD/PhD/MD with at least 5 years of experience conducting observational and Phase IIIb/IV studies; MS/MPH with 10+ years similar experience.
• Experience delivering a portfolio of protocols aligned with strategic program objectives.
• Experience responding to regulatory agency and IRB/Ethics Committee questions about study designs and protocol conduct.
• Proven track record of working with cross-functional partners to deliver end-to-end studies in support of product Integrated Evidence Plans.
• Track record delivering high-quality observational and Phase IIIb/IV studies.
• Ability to operate in a cross-functional matrix to shape study strategy for multiple projects.
• Awareness of novel prospective observational and interventional study designs.
• Strong understanding of statistical and data analysis, research methods and design.
• Experience in study monitoring.
• Advanced knowledge of the clinical research process and Good Clinical Practice (GCP).