Director, Patient-Centered Outcomes Research
The Director will be supporting Regeneron’s Patient-Centered Outcomes Research (PCOR) needs. Positioned within HEOR, we evaluate and generate empirical evidence strengthening our global development and commercialization activities. You will understand the patient experience in terms of how they feel, function and survive, including symptom evolution and how that in turn impacts functioning, and health-related quality of life. We use our unique and important patient insights to inform holistic measurement strategies in clinical trials and real world evidence studies. As a technical expert in PCOR, measurement science and mixed methods we will make a real and meaningful difference to patients.
Ensure a patient-focused approach addressing the needs of all key stakeholders (patients, families, healthcare, professionals, regulators, and payors).
A typical day may include the following:
Collaborate with internal teams to understand patients experiences in target populations of interest.
Assess literature and existing Patient Centered Outcomes (PCOs), conducting gap analyses and designing and overseeing PCOR activities.
Leverage measurement science expertise to ensure the development of treatments that address aspects of disease that are most important to patients.
Ensures PCO’s are appropriately implemented in clinical trials, reviewing clinical protocol sections and conducting PCO training at Investigator Meetings.
Serve as a measurement science expert on FDA’s Patient Focused Drug Development (PFDD) and EMA’s Patient-Reported Outcomes (PRO) and Health-Related Quality of Life.
Supporting our PCO drug labeling strategies; including developing questions to the agencies, producing PCO evidence dossiers for regulatory submissions, and meetings.
Reflect patients’ perspectives on the benefits and risks of treatment in drug evaluation and ensuring that the information that emerges from our development programs.
Develop statistical and psychometric analysis plans; supporting the analysis in-house, overseeing those conducted by external partners, and communicating results to internal partners.
Communicate data externally including the analysis and reporting in Clinical Study Reports, and to clinical, scientific, academic and patient communities.
Attend relevant governmental, professional and industry meetings/conferences and maintain awareness of new scientific and regulatory developments.
Collaborate with partners on HEOR plans, studies and projects; build and maintain constructive and productive relationships across Alliance.
This may be for you if:
• Have a culture of “Team-focus” and “rapid-response”.
• Demonstrated ability to lead projects with high impact.
• Want to work on projects directly affecting patient lives.
To be considered for this you are required to have either a PhD with 7+ years or a with Masters or 9+ years in PCOR within pharma/biotech, consulting, or academia. Recognized expert in PCO selection, development, validation and demonstration of clinically meaningful change. Ability to communicate mixed methods (qualitative and quantitative), and statistical key findings to technical and non-technical audience. Demonstrated ability developing solutions to problems of unusual complexity often requiring a high level of ingenuity, creativity and innovativeness.
• Doctoral degree (preferably PhD) in clinical/health psychology, health services research, or a related subject area. Your experience should include a strong focus in the application of patient-relevant data and measurement science in healthcare.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.