Sr. Manager/Associate Director, Regulatory Outcomes ResearchLocation San Rafael, California Apply
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.
The Sr. Manager/Associate Director will join the Regulatory Affairs Outcomes Research team to support the development and implementation of global outcomes research strategies to support products across the pipeline. The development of new instruments and validation of existing instruments for a specific indication will be performed within a collaborative cross-department model.
- The Sr. Manager/Associate Director interacts frequently with multiple members across the company including Regulatory, Development Sciences, Clinical Sciences, Product Development, and Market Access.
- For assigned program(s), lead the development and implementation of regulatory strategy for outcomes research including the strategy for agency interactions, regulatory questions, outcomes labeling, and submissions related to COAs.
- Strategize on COA development/modification, selection, and implementation in clinical trials with an understanding of the clinical development program.
- Assess literature and existing COAs, conduct gap analyses, and develop and implement plans to address COA needs. Identify and recommend appropriate COA measures and lead activities to validate available COAs.
- Interact with vendors including review and finalization of COA materials to ensure they are fit for purpose for assigned program(s).
- Provide technical expertise in the analysis, reporting and dissemination of COA data.
- Develop COA evidence dossiers for regulatory submissions for assigned program(s)
- Develop COA/PRO sections of regulatory documents, including briefing documents and submissions.
- Interact with regulatory agencies regarding COA endpoints on behalf of BioMarin.
- Maintain awareness of scientific and regulatory developments and communicate information internally and develop strategies that leverage changes in the regulatory environment
Experience and Skills:
- The candidate should have experience working in applicable settings, including government agencies, biopharmaceutical companies, research organizations, academic institutions, or, performing outcomes research, including COA selection, and PRO development and validation.
- The ideal candidate will bring experience in clinical trial design, collection and analysis of study data, preparation of relevant COA related documentation for regulatory submissions, and a working knowledge of applicable FDA guidelines for labeling claims and PRO development.
- A Master’s or doctoral degree in the field of Epidemiology, Public Health, Psychology, Psychometrics, Health Research, clinical (medicine, pharmacy or nursing) or related is required. Patient Reported Outcomes experience is especially critical.
- Strong communication including strong written and verbal presentation skills is required. Attention to detail is critical.
- Ability to collaborate cross-functionally and ability to multi-task across several projects.
- Experience interacting with regulators, policy makers, and experts in the field is preferred.
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.