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Medical Director, Clinical Science

Company: BioMarin
Location: San Rafael
Posted on: September 22, 2019

Job Description:

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind. BioMarin s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development 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. Come join our team and make a meaningful impact on patients lives. RESPONSIBILITIES: * Provide medical leadership while working in a matrixed, cross-functional environment, within key functions of discovery science and development. Balance activities between pre-clinical and early clinical development. Drive analytics, insights and help define strategy for projects * Develop early clinical development plans that are innovative, safe and create a foundation for decision making * Be responsible for Phase 0, First-in-Human, Proof-of-Mechanism and Phase 1 studies throughout development, including validation of innovative clinical biomarkers to support decision making * Provide clinical and translational leadership to drive the design and interpretation of Phase 0-2a studies, in close collaboration with experts in Clinical Pharmacology, Clinical Biomarkers, Biostatistics, Modeling & Simulation, and Clinical Operations * Work with teams to ensure effective execution of Phase 0-2a studies within the portfolio * Partner with the project team in the selection and engagement of external collaborators/KOL s to guide the translational strategy across the discovery-development continuum * Responsible in collaboration with Global Patient Safety for safety evaluation in early development programs * Support exploratory biomarker efforts to aid in clinical and project decision making * Provide clear and timely communication and interpretation of study results to department and organizational governance, functional area experts and development review committees * Engage with external academic and industry partners in planning and executing strategy and clinical studies * Engage with external scientific and medical experts to bring insight to development programs * Work with colleagues across the research and clinical organizations to foster an end-to-end view of drug development, with a focus on improving patient care QUALIFICATIONS: * MD or MD/PhD required * Strong record of basic and/or translational research productivity * Solid foundation and interest in molecular and population genetics * Board certified or eligible in a medical or pediatric subspecialty preferred * Early clinical development experience in an industry setting preferred * Experience with design, execution, and analysis of Phase 0-2a clinical studies preferred * Effective at building alliances across functions, based on end-to-end drug development thinking and experience * Excellent interpersonal communication skills, able to drive collaborations across a matrixed organization We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Keywords: BioMarin, Sacramento , Medical Director, Clinical Science, Healthcare , San Rafael, California

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