Director, Patient-Centered Outcomes Research
As a Director of Patient-Centered Outcomes Research (PCOR) within HEOR, you will evaluate and generate empirical evidence to strengthen Regeneron's global development and commercialization activities. Specifically, perform PCOR activities to understand the patient experience in terms of how they feel, function and survive. The overall responsibilities are to ensure a patient-focused approach across product lifecycles addressing the needs of all key partners (patients, families, healthcare, professionals, regulators, and payors).
A typical day may include:
Collaborating with Clinical Development, Regulatory Affairs and Commercial to understand patients’ experiences in target populations of interest. These efforts will be used to inform the conceptualization of clinical benefit supported by holistic measurement strategies for product approval, labeling, patient access and medical differentiation.
Assessing literature and existing PCOs, conducting gap analyses and designing and leading activities to address those gaps. This may include the execution of patient, caregiver and clinician interviews (concept elicitation, cognitive debriefing and entry/exit interviews).
Demonstrating your measurement science expertise to ensure the development of treatments that meaningfully address aspects of disease that are most important to patients. Includes ensuring PCO’s are appropriately implemented in clinical trials, reviewing relevant clinical protocol sections and conducting PCO training at Investigator Meetings.
Advising with your in-depth knowledge of the FDA’s Patient Focused Drug Development (PFDD) and EMA’s Patient-Reported Outcomes (PRO) and Health-Related Quality of Life reflection papers. Supporting teams in PCO drug labeling strategies; including developing questions to the agencies, producing PCO evidence dossiers for regulatory submissions, and attendance to 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 accurately represents those and is directly relevant to patients’ treatment decisions.
Developing statistical and psychometric analysis plans; supporting the analysis in-house, overseeing those conducted by external partners, and effectively communicating results to internal partners.
Communicating PCOR data externally including the analysis and reporting in Clinical Study Reports, as well as to clinical, scientific, academic and patient communities in a meaningful way.
Attending relevant governmental, professional and industry
meetings and conferences to maintain awareness of new scientific and regulatory developments.
Collaborating with Alliance partners on HEOR plans, studies and deliverables; build and maintain constructive and productive relationships across Alliance.
This may be for you if:
• Can demonstrate significant experience in PCO selection, development, validation and demonstration of clinically meaningful change.
• Have a culture of “Team-focus” and “rapid-response”.
• Can develop solutions to problems of unusual complexity often requiring a high level of resourcefulness, creativity and innovativeness.
• Demonstrated ability to lead projects with high impact.
To be considered for this you are required to have a degree in clinical/health psychology, health services research, or a related subject area with a strong focus in the application of patient-relevant data and measurement science in healthcare. Any advanced degree would be preferred.
• A minimum of 7 years’ experience in pharma/biotech, consulting, or academic settings in PCOR with a Doctorate degree, 9+ with Master’s degree or 10+ with a Bachelor’s degree
• Able to effectively communicate mixed methods (qualitative and quantitative), and statistical key findings.
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.