Associate Director of Patient Engagement & 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 Associate Director of Patient Engagement & Outcomes Research, as part of the Regulatory Patient Engagement and Outcomes Research (Reg PE/OR) team, represents both outcomes and patient engagement functions of the Regulatory Affairs department at BioMarin. Reporting to the Senior Director of Regulatory Patient Engagement and Outcomes Research, the Associate Director interacts with multiple functions including Regulatory, Development Sciences, Clinical Sciences, Product Development, and Market Access.
Patient Engagement: This position is responsible for the development and implementation of patient engagement strategy to ensure the patient voice is incorporated in development and the regulatory process. This includes developing a high-level understanding of the condition or disease in focus; developing knowledge and staying current on the overall development and status of relevant programs at BioMarin; maintaining an understanding of the regulatory status of the program; the ability to work cross functionally in developing and implementing overall strategy, developing and implementing plans to gather and generate patient experience data and information; developing other relevant patient engagement plans across the lifecycle of relevant programs. This role will focus on activities in the US and EU.
The PE role demands precision, flexibility, and an ability to prioritize multiple demands including maintaining close collaborative relationship with internal stakeholders (eg, patient advocacy) and critically, external patient groups. Importantly the AD in this role is in frequent contact with colleagues within the regulatory team and independently represents Regulatory PE/OR at all internal (and some external) regulatory activities related to the assigned program (s).
Outcomes Research: Expectations include developing regulatory strategy for clinical outcomes assessments (COAs) including and importantly PROs utilized in the development programs. Ensuring robust and fit-for-purpose COAs are being implemented is a key part for this role.
The position provides input in protocol development keeping key regulatory guidance and precedent at the forefront of the considerations for selection of an existing tool or recommendation of development of a de novo instrument. Review of regulatory communication and input and drafting of COA-related documentation for regulators is a core aspect. The position participates in a cross-functional outcomes effort as an SME and requires assuring Reg PE/OR are in alignment with several functions clinical, market access, and other, across the company. The position represents Reg PE/OR internally and at meetings with regulators.
Experience and Skills:
- The candidate should have experience working in applicable settings, including biopharmaceutical companies, research organizations, academic institutions, or government agencies, performing outcomes research, including PRO selection, 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.
- The candidate should have a good understanding of rare diseases.
- The candidate has a background in patient engagement via regulatory environment or other with patient advocacy groups.
- 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.
- Experience interacting with regulators, policy makers, and experts in the field is preferred.
- Strong and effective communication, including strong written and verbal presentation skills is required.
- Effective time-management, and ability to work effectively on multiple projects is required.
- Ability to work collaboratively, flexibly, and ability to meet shifting timelines and in a cross-functional environment is required.
This position is located at BioMarin headquarters in San Rafael, CA. Travel is estimated a 10-25%, with the possibility of international travel as needed.
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.