The Associate Director will join the Regulatory Affairs Outcomes Research & Patient Engagement team to support the development and implementation of global outcomes research strategies to support products across the pipeline. In this role, the Associate Director will provide Clinical Outcomes Assessment (COAs) including Patient Reported Outcomes (PROs), support and consultative expertise for BioMarin products from early development through launch and commercialization. The development of new instruments and validation of existing instruments for a specific indication will be performed within a collaborative cross-department model. The role includes strategizing on COA selection and also implementation of COAs in clinical trials with an understanding of the clinical development program.
The Patient Engagement role includes support of all patient engagement activities within Regulatory Affairs. Projects include input on overall strategy, engaging with key external stakeholders, and working collaboratively across products with internal teams who oversee patient advocacy initiatives.
The Associate Director of Outcomes Research and Patient Engagement, with the Director of Outcomes Research and Patient Engagement, represent both outcomes and patient engagements functions of Regulatory Affairs. The Associate Director interacts frequently with multiple members across the company including Regulatory, Development Sciences, Clinical Sciences, Product Development, and Market Access.
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 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.
Preferred but not required skill: The candidate has a background in patient engagement and/or work with patient advocacy groups and preferably in rare disease environment
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.
Strong communication including strong written and verbal presentation skills is required.
Experience interacting with regulators, policy makers, and experts in the field is preferred.
Ability to work collaboratively in a cross-functional environment is required.
This position is located at BioMarin headquarters in San Rafael, CA. Travel is estimated a 10%, with the possibility of international travel as needed.
At BioMarin, we focus on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. BioMarin remains steadfast to its original mission—to bring new treatments to market that will make a big impact on small patient populations. These patient populations are mostly children, suffering from di...seases so rare, that the entire patient population can number as few as 1,000 people worldwide. These conditions are often inherited, difficult to diagnose, progressively debilitating, have few, if any, treatment options, and are usually ignored.