Sr Medical Director, Clinical Science (PKU)Location San Rafael, California
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.
BioMarin Pharmaceutical seeks a M.D. with suitable background and experience in the biotech/pharma industry (or related) to join a multidisciplinary clinical research team and oversee clinical trial execution and output. The Senior Medical Director will support important clinical development programs testing a novel potential treatments for phenylketonuria and the strategic development and execution of global clinical development plan including the opportunity to participate in global regulatory filing activities. The current focus of drug development is in the rare/orphan and/or gene therapy disease area. Experience with FDA and/or other health authority and filings experience a strong plus.
- Lead preparation of clinical sections of all relevant regulatory filings (IND, study reports, NDA, etc), especially BLA filing experience highly desired
- Lead strategic planning and execution of clinical trials,
- Provide clinical expertise for the research and development projects under their care; lead clinical science aspects of regulatory filings
- Serve as the Medical Monitor for clinical trials; participate in management of studies and serve as expert on clinical and medical issues to other colleagues and study site staff
- Collaborate with internal stakeholders (Development Science Project Management Clinical Operations, Regulatory, Medical Affairs, Science, Commercial, Core team) to ensure successful management of project
- Build relationships with and collaborate with investigators and key opinion leaders to assure implementation of latest clinical thinking and guidelines into the clinical development plan
- Serve as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contract resources; participate in the pharmacovigilance reporting process
- Assist in clinical project and protocol development in general; provide ongoing medical input into study documentation, e.g. source data verification plans, case report form design etc
- Attend and provide scientific and medical support for investigator meetings
- Participate in analysis and interpretation of interim and final study data with internal colleagues and external investigators
- Participate in the writing of final study reports and lead the data dissemination plan for projects under their care; including development of publications, abstracts, and presentations; represent the company at scientific meetings
- Support other functions within the organization as appropriate; this may include business development activities, science projects
- Relevant experience in pharmaceutical/biotech or related industries. For appointment at the Senior Medical Director level a minimum of 5 years relevant experience is required
- Outstanding leadership, presentation, written and oral communication skills required
- Collaborative and flexible in interactions at all levels within the company, and with external collaborators
- Ability to work proactively and effectively, with exceptional creative problem-solving skills
- Excellent strategic planning, organizational, analytical and communication skills
- Knowledgeable and current in GCP guidelines in US and Europe; regulatory filing experience would be advantageous
- Be well connected within the medical and scientific community and have a proven successful track record
- Experience in one/more of the following therapeutic areas would be considered advantageous: metabolic disease, genetics, immunology
- MD, MD/PhD, DO and post graduate clinical experience essential (i.e., U.S. internship/residency, board-eligible as a minimum or fellowship).