Senior Medical Director, Clinical Science

Overview

As Senior Medical Director, you will shape and execute late-stage clinical development for one or more assets within BioMarin’s rare-disease portfolio. You will lead end-to-end clinical strategy, lifecycle management, and regulatory interactions to ensure rigorous, data-driven decisions. You’ll collaborate with Regulatory, Clinical Operations, Biostatistics, Pharmacovigilance, Medical Affairs, and Commercial teams to deliver differentiated patient value. This role combines scientific leadership with portfolio stewardship and external engagement to advance programs toward registration and beyond. You will influence governance bodies, thought leaders, and patient advocacy groups, shaping the未来

Responsibilities

• Own the asset-level clinical development strategy and develop CDPs aligned with product strategy
• Serve as clinical development team leader (CDTL) through registration and lifecycle management
• Drive clinical strategy discussions and participate in governance with safety, efficacy, and benefit-risk considerations
• Identify opportunities to accelerate timelines, optimize study designs, and mitigate risks
• Lead regulatory strategy in partnership with Regulatory Affairs and interact with global authorities
• Lead preparation for major regulatory milestones and regulatory document authoring
• Provide strategic oversight of study execution and mentor study teams
• Act as Medical Monitor on selected studies and lead data review meetings
• Lead safety reviews with Pharmacovigilance and communicate findings to leadership
• Maintain deep disease biology expertise and build relationships with thought leaders and patient groups
• Drive publication strategy and support congress activities
• Mentor Clinical Scientists and contribute to talent development and SOP improvement
• Support business development assessments with clinical input
• Represent BioMarin as a thought leader in the therapeutic area

Key requirements

• MD or MD/PhD (or international equivalent) with board certification or specialty training preferred
• Typically 10+ years in biotech/pharma development or related fields
• Extensive experience leading multi-phase clinical programs including registrational studies
• Proven track record interacting with global regulatory authorities and contributing to major submissions
• Experience in rare genetic, metabolic, or orphan diseases; gene therapy or enzyme replacement therapy a plus
• Prior experience as Medical Monitor and leading cross-functional teams
• Strong scientific writing, executive communication, and stakeholder influence skills

• leadership
• stakeholder influencing
• cross-functional collaboration
• clinical development strategy
• CDP development
• regulatory strategy and interactions

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