Senior Medical Director, Early Clinical Development

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United States

BioMarin Pharmaceutical

Senior Medical Director, Early Clinical Development

Location: United States

Workstyle: Remote Only

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Who We Are

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

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

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.

About Worldwide Research and Development

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.

OverviewÂ

BioMarinâ€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 endâ€'toâ€'end clinical leadership from firstâ€'inâ€'human studies through demonstration of clinical proof of concept, with accountability for scientific rigor, strategic clarity, and development decisionâ€'making during the highestâ€'risk phases of development.Â

Leveraging deep expertise in translational clinical research and earlyâ€'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 BioMarinâ€s assets are optimally positioned to generate highâ€'value insights that inform downstream development and regulatory strategy.Â

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In addition to assetâ€'level leadership, the Senior Medical Director will contribute broader portfolioâ€'level clinical perspective across BioMarinâ€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.Â

Key Responsibilities:

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Clinical Strategy and LeadershipÂ

• Develop clinical development plans that serve as the strategic foundation for full development of assigned assets, with emphasis on demonstrating proof of mechanism firstâ€'inâ€'human and firstâ€'inâ€'patient studies, and subsequent demonstration of clinical proof of concept.
• Serve as clinical development team leader (CDTL) for assets from the research phase through completion of human POC studies.Â
• Provide scientific and clinical leadership across multiple assets, balancing strategic priorities and resource allocation.Â
• Make recommendations at key development and governance decision points, incorporating safety, efficacy, and benefitâ€'risk considerations.Â

Clinical Development ExecutionÂ

• Lead clinical contributions to pre-IND, IND, and other stageâ€'appropriate regulatory submissions.Â
• Collaborate with Research and Translational Science colleagues to integrate innovative experimental designs that inform clinical development strategy and regulatory filings.Serve as Medical Monitor on selected studies, as appropriate.

Translational and Biomarker StrategyÂ

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• 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.Â
• Partner with Biomarker and Clinical Pharmacology colleagues to ensure robust plans for patient selection, pharmacodynamic assessments, response biomarkers, and potential approval endpoints.Â

Portfolio, Talent, and Organizational Development

• Provide matrixed leadership and mentorship to Early Clinical Development colleagues.Â
• May directly manage and develop more junior Medical Directors.Â
• Define capability needs for the ECD function and contribute to recruitment, training, and retention strategies.Â
• Establish and evolve standard operating procedures, decision frameworks, and best practices across the ECD organization.Â

Business Development SupportÂ

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• Serve as a clinical expert supporting new project identification, including internal pipeline opportunities and business development assessments.
• Translational and Biomarker Strategy
• 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.
• Partner with Biomarker and Clinical Pharmacology colleagues to ensure robust plans for patient selection, pharmacodynamic assessments, response biomarkers, and potential approval endpoints.

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.Â

Equal Opportunity Employer/Veterans/Disabled

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: $284,000 to $390,500. 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

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.

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.

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.

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

Equal Opportunity Employer/Veterans/Disabled

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.

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, email Applicant_accommodations@bmrn.com with your request.

This 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.

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 â€" please do not contact hiring managers directly. Agencies who wish to offer their services to BioMarin Pharmaceutical may contact us at talentacquisition@bmrn.com.

Applicants, please do not use this email address to submit resumes â€" if you do so, you will be redirected to apply through the website.

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

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