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Medical Director, Clinical Science, Gene Therapy for Hemophilia A

Company: BioMarin Pharmaceutical
Location: San Rafael
Posted on: May 16, 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.

As a vital member of the valoctocogene roxaparvovec (previously known as BMN 270) Clinical Science (CLS) team, the Medical Director is responsible for the medical and scientific integrity during study planning and execution and is accountable for the day-to-day CLS medical monitoring deliverables. Key responsibilities, as delegated by the Clinical Development Team Lead, include:


  • Provide medical and scientific input into the clinical development program
  • Provide CLS input in all stages of the clinical trial, from start-up to close-out
  • Monitor patient eligibility, safety, and data and initiate appropriate action, as needed
  • Represent CLS as a member of the Study Execution Team (SET)
  • Ensure detail-oriented contributions are of high-quality and in compliance with regulatory requirements

    RESPONSIBILITIES

    • Medical and Scientific Oversight


      • Act as the medical and scientific subject matter expert, and primary contact, for the assigned clinical study, which includes being readily available to advise on study-related medical questions or problems during the conduct of the study
      • Initiate and provide the medical and scientific input into and review of: protocols, protocol amendments; case report forms; adverse events (AEs); clinical study reports (CSRs); data management and statistical tables and listings; audit reports; and regulatory submissions
      • Facilitate the review and approval of all study-related CLS deliverables and content


        • Clinical Study Planning and Execution


          • Act as study scientific and medical subject matter expert and main point of contact for Principal Investigators (PIs) and sites to assess patient eligibility, discuss safety concerns, provide scientific/medical rational, and manage ongoing protocol issues
          • Ensure protocols are followed and participate in development of protocol amendments
          • Provide medical leadership to sites by developing or participating in training, answering investigator questions about the protocol and the medical management of subject emergencies
          • Respond to site and Health Authority questions about the protocol
          • Attend and present at Investigator Meetings, as needed
          • Conduct medical review, assessment, and interpretation of clinical and safety data to ensure that the data are complete, accurate, and presented with the appropriate medical interpretation
          • Review and analyze serious AEs, safety, and efficacy trends
          • Contribute to and review CSR writing (e.g., review final tables/listings/graphs, work with the medical writer to review & revise CSR document, draft discussion and conclusions, participate in comment resolution meetings)
          • Present study updates and topline results to CLS leadership, as needed
          • Recommend and develop Key Opinion Leader (KOL) and Advisory Panel networks, as appropriate
          • Provide representation at regulatory meetings, as needed


            • Clinical Governance / Team Membership and Leadership


              • Act as the primary point of contact between SET and CLS to ensure appropriate dissemination of information and communication (including functional managers and other relevant individuals)
              • Proactively identify and communicate potential risks and mitigations relevant to CLS deliverables
              • Contribute to development and maintenance of study-specific plansthat are the responsibility of CLS

                EDUCATION AND EXPERIENCE

                • MD or MD, PhD with country licensure or fellowship required
                • Medical specialty in hematology and experience in hemophilia and/or gene therapy desirable; sub-specialty experience in clinical trials, molecular medicine, data analysis also desirable
                • At least 2 years of relevant experience in CLS, medical affairs, and/or drug development; 2-5 years' clinical trial experience after fellowship in academia is acceptable as well

                  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 Pharmaceutical, Yuba City , Medical Director, Clinical Science, Gene Therapy for Hemophilia A, Executive , San Rafael, California

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