BioMarin Pharmaceutical Inc.
Medical Scientific Director
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Medical Scientific Director
Associate Director – London (Hybrid Role)
About BioMarin
BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions. Since our founding in 1997, our global teams have developed groundbreaking therapies for conditions such as:
- Achondroplasia (most common form of dwarfism)
- PKU (phenylketonuria)
- CLN2 (a form of Batten disease)
- Various forms of MPS (mucopolysaccharidosis)
- Fabry disease and Pompe disease (following the Amicus acquisition)
Our success stems from our commitment to excellence, patient-centred science, and world-class manufacturing, supported by the brightest minds in the industry.
About Worldwide Research & Development
BioMarin’s R&D engine spans from research and discovery to post-market clinical development, encompassing all bench and clinical research. Our goal is to deliver first-in-class and best-in-class therapeutics that address unmet needs in rare diseases.
The Role
Position Summary
The Medical Scientific Director is an Associate Director responsible for:
- Overseeing the day-to-day management of BioMarin-sponsored and collaborative studies across therapeutic areas.
- Ensuring consistency in approach, conduct, monitoring, analysis, and reporting within assigned programs.
- Partnering with Real World Evidence (RWE)/Epidemiology, Global Medical Leads, Data Sciences, and Global Study Operations to develop practical study strategies, ensure optimal operational support, and execute Medical Affairs-led studies.
This role is part of the Integrated Evidence function, which integrates domain experts in evidence planning, observational study design, and data interpretation to:
- Drive excellence in evidence generation (non-interventional, low-interventional, and Phase IIIb/IV studies).
- Support patient and endpoint selection for clinical studies.
- Inform medical practice on safe, effective long-term use of BioMarin products.
- Enhance clinical adoption via robust evidence.
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Key Responsibilities
Study Strategy & Implementation
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Executes evidence generation activities, filling gaps identified in the Product Integrated Evidence Plans (IEPs).
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Collaborates with Global and Country Medical Leads, RWE Lead, and HEOR to align study execution with global and local needs.
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Works with operational partners to ensure timely issue resolution, problem-solving, and escalation for complex challenges.
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Provides scientific leadership in:
- Study concepts, protocols, and their amendments.
- Statistical analysis plans, data review plans.
- Responses to regulatory agency scientific questions.
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Leads development of annual, interim, and periodic study reports, including:
- Coordination with Subject Matter Experts (SMEs).
- Data interpretation and presentation.
- Ensuring regulatory queries (where applicable) are addressed.
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Designs secondary data analysis plans using BioMarin’s clinical and real-world data.
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Provides medical monitoring oversight for assigned studies, including:
- Qualification of subject eligibility.
- Safety and data quality assurance.
- Development and review of Informed Consent Forms (ICFs), Case Report Forms (CRFs), Trial Master Files (TMFs), and accurate AE/concomitant medication coding.
- Preparation for inspections and audits.
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Presents results in internal/external forums, including scientific conferences.
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Coordinates Medical Affairs input for regulatory submissions, agency interaction, Ethics Committee queries, and audit preparations, including program regulatory inspections.
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Participates in efficiency enhancement initiatives in study implementation.
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Desired Experience
- A degree in PharmD, PhD, or MD with at least 5 years in observational Phase IIIb/IV studies within Clinical Development or Medical Affairs. (Accepting equivalents such as MS/MPH with 10+ years of comparable experience.)
- Portfolio management experience, ensuring studies meet strategic program objectives.
- Proven track record of responding to regulatory agency or IRB/Ethics Committee questions on study design/protocol conduct.
Key Skills
✅ Collaborative expertise – Successfully delivers end-to-end studies aligned with Integrated Evidence Plans, working cross-functionally.
✅ Evidence generation skills – Strong track record in designing and overseeing high-quality observational and Phase IIIb/IV studies.
✅ Cross-functional leadership – Shapes study strategy in matrix settings, leading small-to-large teams.
✅ Novel study design awareness – Knowledge of modern observational and interventional approaches.
✅ Statistical and data proficiency – Understanding of methods, analysis, and pharmacopidemiological principles.
✅ Study monitoring – Extensive field experience with rigorous adherence to Good Clinical Practice (GCP) and Good Pharmacopidemiology Practice (GPP) standards.
✅ Scientific writing documents – Expert in developing policies, reports, and regulatory submissions.
Equal Opportunity Employer
BioMarin is committed to diversity and inclusion in employment. We evaluate qualified applicants without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, veteran status or disability, and prohibit discrimination in all aspects of employment.
(Note: This description is not exhaustive; responsibilities may include additional tasks.)
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