Medical Director, Clinical Science

Role Summary

The Medical Director, Clinical Science is a key scientific and analytical leadership role within BioMarin Clinical Science (CLS), overseeing core deliverables across study planning, design and execution, results analysis and regulatory filings. The role includes acting as a study Medical Monitor, providing scientific input into CLS study deliverables, monitoring subject eligibility and study data, and contributing to the interpretation and integration of clinical study results. The Medical Director will contribute to the scientific strategy and plan outlined in the Clinical Development Plan (CDP) and provide medical input to support decision making, problem solving, safety surveillance, and collaboration with external physician stakeholders. This is a fully remote role based in the US.

Responsibilities

• Support the definition of the core clinical and scientific strategy that serves as the basis for the CDP and provide CLS expertise in the design and execution of clinical studies under the purview of the CDP
• Participate in the development of CLS-assigned sections of regulatory filings and in drafting regulatory responses with Medical Writing
• Establish relationships with investigators and KOLs as appropriate in support of the CDP
• Stay up to date with advances in literature in the therapeutic/disease area including mechanism of action, diagnostic tests, treatment, drug development trends, and regulatory requirements
• Develop therapy-specific publication plans and work with internal and external colleagues to prepare study results for timely publication
• Attend and contribute to relevant scientific conferences, seminars or presentations
• Act as the scientific subject matter expert for assigned clinical study; identify issues and mitigate risk
• Develop and review protocols, protocol amendments; ICFs; CRFs; statistical tables and listings including AE coding; audit reports; clinical study reports; regulatory submissions
• Provide clinical input to the statistical analysis plan to align with regulatory and business interests
• Review and approve CLS deliverables and content
• Act as study SME and main contact for PIs and sites to assess eligibility and manage protocol issues
• Provide training to sites and respond to site and Health Authority questions about the protocol
• Review protocol deviations with Clinical Operations Study Lead
• Attend Investigator Meetings as needed
• Conduct data review and interpretation of clinical data, including SAEs and important AEs
• Review and analyze SAEs, safety and efficacy trends; provide medical input into safety reports and DSURs; prepare regulatory safety documentation as needed
• Participate in data snapshot activities (DBL, TLFs) and collaborate with Biostatistics to address key issues
• Lead interactions with independent DMCs where applicable
• Act as medical SME for review of clinical and safety data and discuss safety concerns with sites
• Provide timely, high-quality contributions to Study Execution Team (SET) and ensure effective dissemination of information
• Escalate issues affecting deliverable quality, timelines, resources, or budget as appropriate

Qualifications

• MD, MD/PhD (or equivalent); advanced degree in life or health sciences (e.g., PhD/PharmD/RN)
• 5 or more years of relevant experience in Clinical Development, with experience in genetic diseases, specialty care, and/or rare diseases desired; clinical experience preferred

Skills

• Scientific leadership and strategic thinking
• Expertise in clinical study design, execution, and regulatory interactions
• Proficiency in medical writing, data interpretation, and safety surveillance
• Strong collaboration with investigators, KOLs, and cross-functional teams
• Excellent communication for scientific publications, presentations, and regulatory discussions

Education

• MD, MD/PhD (or equivalent)
• Advanced degree in life or health sciences (e.g., PhD/PharmD/RN)