Senior Medical Director, Early Clinical Development

<p><strong><span style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;">Who We Are </span></strong><br /><br /><span style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;">BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.</span><br /><br /><span style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;">Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.</span><br /><br /><span style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;">Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world. </span><br /><br /><span style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;"><strong>About Worldwide Research and Development</strong> </span><br /><br /><span style="font-family: sans-serif , arial , helvetica;"><span style="font-size: 12.0pt;">From research and discovery to post-market clinical development, our R&D engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases.</span> </span></p><p><strong><span style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;">Overview </span></strong></p><div><div><span style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;">BioMarin’s Early Clinical Development (ECD) team is seeking an accomplished Senior Medical Director to serve as a senior clinical leader responsible for shaping and executing early clinical development strategies across one or more assets within the early pipeline. This role encompasses end‑to‑end clinical leadership from first‑in‑human studies through demonstration of clinical proof of concept, with accountability for scientific rigor, strategic clarity, and development decision‑making during the highest‑risk phases of development. </span></div></div><div><div><span style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;">Leveraging deep expertise in translational clinical research and early‑phase trial design, the Senior Medical Director will lead integrated clinical development planning, design and oversee highly informative Phase 1 and Phase 2 studies, and guide key investment and governance decisions based on emerging safety, pharmacology, biomarker, and efficacy data. The role partners closely with colleagues in Early Clinical Development, Biomarkers, Clinical Pharmacology, Preclinical Safety, Clinical Safety, Regulatory, and Clinical Operations to ensure BioMarin’s assets are optimally positioned to generate high‑value insights that inform downstream development and regulatory strategy. </span></div><div> </div></div><div><div><span style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;">In addition to asset‑level leadership, the Senior Medical Director will contribute broader portfolio‑level clinical perspective across BioMarin’s early pipeline, support evaluation of new internal programs and external business development opportunities, and provide mentorship and leadership within the ECD organization. This position is expected to interact regularly with senior governance bodies, health authorities, and external scientific experts, and to represent BioMarin as a thought leader in early clinical development. </span></div><div><div><div><strong><span style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;"></span></strong></div><div><strong><span style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;">Key Responsibilities:</span></strong></div><div><span style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;"> </span></div></div><div><div><strong><span style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;">Clinical Strategy and Leadership </span></strong></div></div><div><ul><li><span style="font-family: sans-serif , arial , helvetica;"><span style="font-size: 12.0pt;">Develop clinical development plans that serve as the strategic foundation for full development of assigned assets, with emphasis on demonstrating proof of mechanism first‑in‑</span><span style="font-size: 12.0pt;">human<span><span style="font-size: 12.0pt;"> and</span> </span><span>first</span></span><span style="font-size: 12.0pt;">‑</span><span style="font-size: 12.0pt;"><span>in</span></span><span style="font-size: 12.0pt;">‑</span><span style="font-size: 12.0pt;"><span>patient</span><span> studies, and </span><span>subsequent</span><span> demonstration of clinical proof of concept.</span></span><span style="font-size: 12.0pt;"> </span></span></li><li style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;"><span style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;"><span style="background-color: transparent;"><span>Serve as clinical development team lead</span><span>er</span><span> (CDTL)</span><span> for assets from the </span></span><span>research phase through completion of human POC studies.</span><span style="background-color: transparent;"> </span></span></li><li style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;"><span style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;"><span><span>Provide scientific and clinical leadership across multiple assets, balancing strategic priorities and resource allocation.</span></span><span> </span></span></li><li style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;"><span style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;"><span><span>Make recommendations at key development and governance decision points, incorporating safety, efficacy, and </span><span>benefit</span></span><span>‑</span><span><span>risk</span><span> considerations.</span></span><span> </span></span></li></ul></div></div></div><div><div><strong><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;">Clinical De<span style="font-size: 12.0pt;">velopment Execution </span></span></strong></div></div><div><ul><li style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;"><span style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;">Lead clinical contributions to pre-IND, IND, and other stage‑appropriate regulatory submissions. </span></li><li style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;"><span style="font-size: 12.0pt;"><span style="font-family: sans-serif , arial , helvetica;">Collaborate with Research and Translational Science colleagues to integrate innovative experimental designs that inform clinical development strategy and regulatory filings.</span>Serve as Medical Monitor on selected studies, as appropriate.</span></li></ul><div><span style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;"><b>Translational and Biomarker Strategy</b> </span></div><div> </div><ul style="margin-top: 0.0in;"><li style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;"><span style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;">Design and execute natural history studies to (1) deepen understanding of targeted patient populations and (2) enable development of endpoints that support efficient demonstration of POC and/or regulatory approval. </span></li></ul><ul style="margin-top: 0.0in;"><li style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;"><span style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;">Partner with Biomarker and Clinical Pharmacology colleagues to ensure robust plans for patient selection, pharmacodynamic assessments, response biomarkers, and potential approval endpoints. </span></li></ul><div><span style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;"><b>Portfolio, Talent, and Organizational Development</b></span></div><div><span style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;"><b></b></span></div><ul style="margin-top: 0.0in;"><li style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;"><span style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;">Provide matrixed leadership and mentorship to Early Clinical Development colleagues. </span></li></ul><ul style="margin-top: 0.0in;"><li style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;"><span style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;">May directly manage and develop more junior Medical Directors. </span></li></ul><ul style="margin-top: 0.0in;"><li style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;"><span style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;">Define capability needs for the ECD function and contribute to recruitment, training, and retention strategies. </span></li></ul><ul style="margin-top: 0.0in;"><li style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;"><span style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;">Establish and evolve standard operating procedures, decision frameworks, and best practices across the ECD organization. </span></li></ul><div><span style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;"><b>Business Development Support</b> </span></div><div> </div><ul style="margin-top: 0.0in;"><li style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;"><span style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;">Serve as a clinical expert supporting new project identification, including internal pipeline opportunities and business development assessments. </span></li><li style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;">Translational and Biomarker Strategy</li><li style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;">Design and execute natural history studies to (1) deepen understanding of targeted patient populations and (2) enable development of endpoints that support efficient demonstration of POC and/or regulatory approval.</li><li style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;">Partner with Biomarker and Clinical Pharmacology colleagues to ensure robust plans for patient selection, pharmacodynamic assessments, response biomarkers, and potential approval endpoints.</li></ul></div><p><span style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;"><strong>Note:</strong> This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. </span><br /><br /><span style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;"><strong>Equal Opportunity Employer/Veterans/Disabled</strong> </span><br /><br /><span style="font-family: sans-serif , arial , helvetica;font-size: 12.0pt;">An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.</span></p>