Associate Director, Patient Centered Outcomes Research
Compensation: $162,355.00 - $206,040.00 /year *
Employment Type: Full-Time
Industry: Executive Management
The Associate Director will be supporting Regeneron's internal Patient-Centered Outcomes Research (PCOR) needs. Positioned within HEOR, Medical Affairs, you will evaluate and generate empirical evidence to strengthen global development and commercialization activities. Specifically, you will perform PCOR activities to 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. The unique and important patient insights will inform patient-centered holistic measurement strategies in clinical trials and real-world evidence studies. You will be a technical expert in PCOR, measurement science and mixed methods, leveraging your key skillset to make a real and meaningful difference to patient's lives everywhere.
The overall responsibilities of the Associate Director in HEOR (PCOR) are to ensure a patient-focused approach across product lifecycles addressing the needs of all key stakeholders (patients, families, healthcare, professionals, regulators, and payors). In partnership with the Head of PCOR and HEOR leads, you will:
- Collaborate with Clinical Development, Regulatory Affairs and Commercial to understand patients experiences in target populations of interest, to inform the conceptualization of clinical benefit supported by holistic measurement strategies for product approval, labelling, patient access and medical differentiation. This would involve selecting/modifying or developing novel patient-relevant endpoints and validating accordingly.
- Assess literature and existing Patient Centered Outcomes (PCOs), conducting gap analyses and designing and overseeing PCOR activities to address those gaps. This may include the execution of various types of patient, caregiver and clinician interviews (concept elicitation, cognitive debriefing and entry/exit interviews).
- Leverage 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.
- Serve as a measurement science expert with significant in-depth knowledge of guidance's (such as FDA's Patient Focused Drug Development (PFDD) guidances and EMA's Patient-Reported Outcomes (PRO) and Health-Related Quality of Life reflection papers), and supporting teams in PCO drug labelling 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.
- Develop statistical and psychometric analysis plans; supporting the analysis in-house, overseeing those conducted by external partners, and effectively communicating results to internal stakeholders.
- Communicate 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.
- Attend relevant governmental, professional and industry meetings/conferences and maintain awareness of new scientific and regulatory developments in the PCOR and measurement science fields within drug development, as well as communicating information internally.
- Collaborate with Alliance partners on HEOR plans, studies and deliverables; build and maintain constructive and productive relationships across Alliance.
- PhD, PharmD, or MD required
- Recognized expert in PCO selection, development, validation and demonstration of clinically meaningful change.
- Develops solutions to problems of unusual complexity often requiring a high level of ingenuity, creativity and innovativeness.
- Able to effectively communicate mixed methods (qualitative and quantitative), and statistical key findings to technical and non-technical stakeholders
- Have a culture of 'Team-focus' and 'rapid-response'.
- Demonstrated ability to lead projects with high impact.
- Ability to work independently with minimal supervision.
- Excellent written and oral communication skills.
- Doctoral degree (preferably PhD) in clinical/health psychology, health services research, or a related discipline with a strong focus in the application of patient-relevant data and measurement science in healthcare.
- A minimum of 4 years' experience in pharma/biotech, consulting, or academic settings in PCOR.
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.
Associated topics: clinical, dietician, drug development, immunoassay, immunology, medicine, microbiological, nutritionist, therapy, transfection
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
Loading some great jobs for you...