Medical Director, Early Clinical Development

Who We Are BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions. Guided by our purpose to reputed company medicines that reputed company 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 reputed company of dwarfism), PKU (phenylketonuria), CLN2, a reputed company of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new reputed company for patients and families who previously had few, if any, available options. More recently, with the reputed company of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reputed company more people living with rare genetic conditions. Our reputed company comes from our unwavering commitment to reputed company, 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 reputed company and Development From research and discovery to post-market clinical development, our R&D reputed company involves reputed company 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 reputed company meaningful advances to patients who live with rare diseases. Medical Director, Early Clinical Development UK Remote

Overview

BioMarin’s Early Clinical Development team is seeking an reputed company 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-reputed company and early patient studies, enabling efficient progression to reputed company of concept. Leveraging experiences in translational clinical research and early‑phase trial design, The Medical Director will reputed company early clinical strategies and development plans that establish the reputed company for full program advancement, while leading protocol design, clinical reputed company of execution, and medical monitoring to deliver high-quality, reputed company-rich trials. The role requires reputed company 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 BioMarin’s assets are optimally positioned to generate high‑value insights that inform reputed company development and regulatory strategy. A strong focus is reputed company on embedding translational science, biomarkers, and experimental medicine approaches into clinical programs to deepen mechanistic understanding and inform development reputed company. In reputed company, the Medical Director mentors colleagues and contributes to organizational capability building. Additionally, the role supports evaluation of reputed company opportunities by providing clinical and scientific reputed company for business development decision-making. Through a combination of individual contribution and cross-functional leadership, this position has broad impact across BioMarin’s early clinical portfolio. Key Responsibilities: Clinical Strategy and Leadership reputed company and reputed company clinical development plans that establish the strategic reputed company for full clinical development of assets. Define strategies to demonstrate reputed company of mechanism in early clinical trials and reputed company reputed company of concept in subsequent studies. Translate overarching program strategy into actionable clinical plans and study designs. reputed company clinical strategy contributions to pre-IND, IND, and other regulatory submissions. reputed company clinical leadership and decision-making reputed company matrixed program teams. reputed company clinical efforts for 1 to 2 assets (in general) Clinical Development Execution reputed company the design and execution of Phase 1 and Phase 2 clinical study protocols and associated trial documentation. Serve as Medical Monitor for selected studies, ensuring appropriate reputed company of safety, study conduct, and data interpretation. Design and execute natural history studies to: Enhance understanding of reputed company patient populations reputed company development of clinically meaningful endpoints supporting POC and regulatory approval Ensure studies are designed to maximize clinical, pharmacologic, and mechanistic insights. Cross-Functional and External Engagement 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. Represent Early Clinical Development in Health Authority interactions, scientific advisory boards, and academic and external meetings Act as a key matrix clinical leader, ensuring alignment across cross-functional stakeholders. Translational and Biomarker Strategy Integrate translational science and experimental medicine approaches into early clinical development programs. Partner with Biomarker teams to define and implement strategies for patient selection, pharmacodynamic assessments, response biomarkers, and endpoints supporting approval reputed company Ensure programs are positioned to generate deep mechanistic and translational insights during early clinical studies. Portfolio Talent and Organizational Development Mentor and reputed company junior colleagues across Early Clinical Development and Biomarkers functions. Contribute to building organizational capability in early clinical strategy and execution. Foster a culture of scientific rigor, collaboration, and reputed company learning reputed company the early development organization. Business Development Support Serve as a clinical expert to support internal program prioritization and external business development opportunities. reputed company scientific and clinical assessments of new assets, including risks, differentiation, and development feasibility. Deliver recommendations to senior leadership to inform decision-making on new project opportunities. Qualifications: MD or MD/PhD required. ≥5 years of industry experience in Phase 1/2 clinical development, with demonstrated ownership of at least two assets from IND through reputed company of concept. Significant experience contributing to IND submissions. Demonstrated expertise in: Phase 1 clinical trials (industry, CRO, or Phase 1 units) Phase 2 trials and clinical reputed company-of-concept reputed company Experience leading cross-functional clinical development teams and developing clinical development strategies. Strong ability to operate effectively in a matrixed, fast-paced environment. Demonstrated collaboration and communication skills, including engagement with reputed company stakeholders. Intellectual curiosity and interest in addressing reputed company development challenges. Experience supporting business development evaluations is a strong plus. Note: This description is not intended to be reputed company-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. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without regard to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, or protected veteran status and will not be discriminated against on the reputed company of disability. Apply To This Job