Medical Scientific Director
BioMarin Pharmaceutical Inc.
June 25, 2026
Remote friendly (San Rafael, CA)
United States
Medical Affairs
The Medical Scientific Director is accountable for the day-to-day oversight of numerous BioMarin-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.
Key Responsibilities:
- 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 BioMarin 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
Desired Experience:
- 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
Skills:
- 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
Key Responsibilities:
- 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 BioMarin 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
Desired Experience:
- 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
Skills:
- 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