Medical Director, Early Clinical Development

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n BioMarin Pharmaceuticaln

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Medical Director, Early Clinical Development

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Location: United States

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Workstyle: Remote Only

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Who We Are

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BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

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Guided by our purpose to develop medicines that make a profound impact on peoplexe2x80x99s 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.

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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.

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About Worldwide Research and Development

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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.

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Overview

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BioMarinxe2x80x99s Early Clinical Development team is seeking an experienced Medical Director to serve as a key matrixed clinical leader focused on the design and execution of highly informative Phase 1 and Phase 2 trials. This role is central to translating early scientific insights into clinical strategies that maximize learning in first-in-human and early patient studies, enabling efficient progression to proof of concept.

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Leveraging experiences in translational clinical research and earlyxe2x80x91phase trial design, The Medical Director will develop early clinical strategies and development plans that establish the foundation for full program advancement, while leading protocol design, clinical oversight of execution, and medical monitoring to deliver high-quality, insight-rich trials.

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The role requires close collaboration across Research, Translational Sciences, and Development, along with external engagement in scientific, regulatory, and advisory settings. The role partners closely with colleagues in Early Clinical Development, Biomarkers, Clinical Pharmacology, Preclinical Safety, Clinical Safety, Regulatory, and Clinical Operations to ensure BioMarinxe2x80x99s assets are optimally positioned to generate highxe2x80x91value insights that inform downstream development and regulatory strategy.

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A strong focus is placed on embedding translational science, biomarkers, and experimental medicine approaches into clinical programs to deepen mechanistic understanding and inform development decisions. In parallel, the Medical Director mentors colleagues and contributes to organizational capability building.

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Additionally, the role supports evaluation of internal and external opportunities by providing clinical and scientific insight for business development decision-making. Through a combination of individual contribution and cross-functional leadership, this position has broad impact across BioMarinxe2x80x99s early clinical portfolio.

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Key Responsibilities:

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Clinical Strategy and Leadership

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• Develop and lead clinical development plans that establish the strategic foundation for full clinical development of assets. n
• Define strategies to demonstrate proof of mechanism in early clinical trials and enable proof of concept in subsequent studies. n
• Translate overarching program strategy into actionable clinical plans and study designs. n
• Lead clinical strategy contributions to pre-IND, IND, and other regulatory submissions. n
• Provide clinical leadership and decision-making within matrixed program teams. n
• Lead clinical efforts for 1 to 2 assets (in general) n

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Clinical Development Execution

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• Lead the design and execution of Phase 1 and Phase 2 clinical study protocols and associated trial documentation. n
• Serve as Medical Monitor for selected studies, ensuring appropriate oversight of safety, study conduct, and data interpretation. n
• Design and execute natural history studies to: n

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• Enhance understanding of target patient populations n
• Enable development of clinically meaningful endpoints supporting POC and regulatory approval n

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• Ensure studies are designed to maximize clinical, pharmacologic, and mechanistic insights. n

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Cross-Functional and External Engagement

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• Partner closely with Early Clinical Development, Biomarkers, Clinical Pharmacology, Preclinical Safety, Clinical Safety, Regulatory Affairs, and Clinical Operations to align on development strategy and execution. n
• Represent Early Clinical Development in Health Authority interactions, scientific advisory boards, and academic and external meetings n
• Act as a key matrix clinical leader, ensuring alignment across cross-functional stakeholders. n

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Translational and Biomarker Strategy

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• Integrate translational science and experimental medicine approaches into early clinical development programs. n
• Partner with Biomarker teams to define and implement strategies for patient selection, pharmacodynamic assessments, response biomarkers, and endpoints supporting approval pathways n
• Ensure programs are positioned to generate deep mechanistic and translational insights during early clinical studies. n

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Portfolio Talent and Organizational Development

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• Mentor and develop junior colleagues across Early Clinical Development and Biomarkers functions. n
• Contribute to building organizational capability in early clinical strategy and execution. n
• Foster a culture of scientific rigor, collaboration, and continuous learning within the early development organization. n

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Business Development Support

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• Serve as a clinical expert to support internal program prioritization and external business development opportunities. n
• Provide scientific and clinical assessments of new assets, including risks, differentiation, and development feasibility. n
• Deliver recommendations to senior leadership to inform decision-making on new project opportunities. n

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Qualifications:

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• MD or MD/PhD required. n
• xe2x89xa55 years of industry experience in Phase 1/2 clinical development, with demonstrated ownership of at least two assets from IND through proof of concept. n
• Significant experience contributing to IND submissions. n
• Demonstrated expertise in: n

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• Phase 1 clinical trials (industry, CRO, or Phase 1 units) n
• Phase 2 trials and clinical proof-of-concept generation n

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• Experience leading cross-functional clinical development teams and developing clinical development strategies. n
• Strong ability to operate effectively in a matrixed, fast-paced environment. n
• Demonstrated collaboration and communication skills, including engagement with internal and external stakeholders. n
• Intellectual curiosity and interest in addressing complex development challenges. n
• Experience supporting business development evaluations is a strong plus. n

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Note: 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.xc2xa0

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Equal Opportunity Employer/Veterans/Disabled

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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.

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The salary range for this position is: $228,500 to $314,160. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

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Recruitment Fraud Alert Notice

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Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent BioMarin in recruitment activities. We have an established recruitment process which is required for all posted positions by BioMarin prior to issuing an offer of employment. This BioMarin process requires formal interviews conducted live with personnel representing BioMarin and never requires payments or fees from job applicants. BioMarin does not conduct interviews via texting tools such as RingCentral.

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In the event you receive a suspicious email message about recruiting on behalf of BioMarin, unless it's from a BioMarin authorized recruiting partner, do not provide any personal information or pay any fees. Qualified and interested candidates should apply to current openings directly through this BioMarin website. BioMarin accepts no responsibility for any costs or charges incurred as a result of fraudulent activity.

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If you have lost money or provided your personal identifying information, please contact your bank and report the matter to the FBI via www.ic3.gov. We would also suggest you notify your local police department and monitor your credit.

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For more information on how to recognize and report phishing scams visit: https://consumer.ftc.gov/articles/how-recognize-and-avoid-phishing-scams or https://consumer.ftc.gov/consumer-alerts/2023/01/looking-job-scammers-might-be-looking-you

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Equal Opportunity Employer/Veterans/Disabled

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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.

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If you have a disability and believe you need a reasonable accommodation in order to search for a job opening or apply for a position, emailxc2xa0Applicant_accommodations@bmrn.comxc2xa0with your request.

nThis email address is not for general employment inquiries or correspondence. We will only respond to those requests that are related to the accessibility of the online application system due to a disability.

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BioMarin Pharmaceutical does not accept unsolicited resumes from recruiters or agencies and we will not be responsible for any fees related to resumes that are unsolicited. We handle all recruiting through our Talent Acquisition team xe2x80x93 please do not contact hiring managers directly. Agencies who wish to offer their services to BioMarin Pharmaceutical may contact us atxc2xa0talentacquisition@bmrn.com.

nApplicants, please do not use this email address to submit resumes xe2x80x93 if you do so, you will be redirected to apply through the website.

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Click here to review "EEO Is The Law" poster.xc2xa0Click here to review the Pay Transparency Nondiscrimination Statement.xc2xa0Click here to review the Notification of Employee Rights under Federal Labor Laws.

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