Medical Scientific Director

The Medical Scientific Director is accountable for the day-to-day oversight of numerous Bio Marin-sponsored and collaborative studies across a therapeutic area, ensuring consistency of approach, conduct, monitoring, analysis, and reporting of studies within one or more programs. Works in partnership with RWE/Epidemiology, Global Medical Leads, Data Sciences, and Global Study Operations to develop practical study strategies and ensure hands‑on study operations and execution support for Medical Affairs-led studies.

• Execute evidence generation activities (non-interventional, low-interventional, and interventional Phase IIIb/IV) to fill priority evidence gaps in Integrated Evidence Plans (IEPs)
• Collaborate with Global and Country Medical Leads, RWE Lead, and HEOR to develop strategic study pull-through and dissemination plans
• Ensure successful implementation of GMAF-led studies; identify issues, lead complex solutions, and/or escalate
• Provide scientific input into study concepts, protocols/amendments, statistical analysis plans, data review plans, and regulatory scientific question responses
• Lead development of annual/interim/periodic study reports for Medical Affairs-led studies (SME coordination, interpretation, presentation, regulatory question responses)
• Design secondary data analysis plans using Bio Marin clinical and real-world data
• Provide medical monitoring oversight (e.g., subject eligibility, safety/study data quality, ICF/CRF/TLG review, AE and concomitant medication coding, inspection readiness)
• Present study results to internal/external stakeholders and at scientific conferences
• Coordinate Medical Affairs input for regulatory submissions, query responses, IRB/Ethics questions, and inspections/audits
• Participate in initiatives to enhance study implementation efficiency

• PharmD/PhD/MD with at least 5 years experience conducting observational and Phase IIIb/IV studies (Clinical Development and/or Medical Affairs); or MS/MPH with 10+ years
• Experience delivering a portfolio of protocols aligned to strategic program objectives
• Experience responding to regulatory agency and IRB/Ethics questions on study designs and protocol conduct

• Cross-functional end-to-end delivery of studies supporting Integrated Evidence Plans
• Delivery of high-quality novel observational and Phase IIIb/IV studies
• Ability to shape study strategy in matrix settings
• Awareness of novel prospective observational and interventional study designs
• Understanding of statistical/data analysis, research methods, and design
• Experience in study monitoring
• Advanced knowledge of clinical research process and Good Clinical/Pharmacoepidemiology Practice standards
• Strong scientific writing and document development