Senior Director, HEOR (Clinical Outcomes Assessment)
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
The Senior Director will develop, deliver and communicate COA (e.g. Patient Reported Outcomes, PROs) measurement strategies and plans in support of the Regeneron product portfolio. The Senior Director will serve as the COA expert and advisor to Health Economics Outcomes Research (HEOR) product lead, Clinical, Regulatory and Commercial colleagues across Regeneron drug development programs.
• Collaborate with Clinical Development, Regulatory Affairs and Commercial to develop and implement COA measurement plans across clinical programs and studies to support product approval, labeling, patient access, and medical differentiation.
• Assess literature and existing COAs, conduct gap analyses and expert interviews to inform COA measurement strategy.
• Identify and select/recommend appropriate COA measures.
• Lead development of COAs/modify existing COAs, including patient concept elicitation, cognitive debriefing, psychometric validation.
• Ensure COAs are appropriately implemented in clinical trials, including reviewing relevant clinical protocol sections and conducting COA training at Investigator Meetings.
• Provide technical expertise in the analysis, reporting and dissemination of COA data.
• Produce COA/PRO evidence dossiers for regulatory submissions (e.g. FDA, EMA); Advise on and contribute to COA/PRO sections of regulatory documents, including briefing documents and submissions.
• Interact with regulatory agencies (e.g. FDA, EMA) regarding COA endpoints on behalf of Regeneron.
• Prepare and submit publications presenting COA data.
• Maintain awareness of scientific and regulatory developments within COA area and communicate information internally.
• Attend relevant governmental, professional and industry meetings/conferences.
• Provide training on COA-related topics across functional areas.
• Identify and maintain successful research relationships with HEOR key opinion leaders and thought leaders.
• Collaborate with Alliance partners on HEOR plans, studies and deliverables; build and maintain constructive and productive relationships across Alliance.
• Advanced graduate degree (Ph.D., MS, or MD, PharmD., B.Pharm with Master's degree) in HEOR-related field (e.g. social sciences, psychology, healthcare/data analytics, health services research, public health, epidemiology);
• 7+ years pharma or consulting experience;
• Strong technical expertise in design and implementation of COA/PRO measurements in clinical trials, including analysis and reporting of COA/PRO data;
• Strong publication track record in COA/PRO area;
• Experience corresponding with regulatory agencies (e.g. FDA, EMA) regarding COA/PRO issues, including attending and presenting at regulatory meetings;
• Excellent written and verbal communication skills required;
• Ability to interact with and present to Senior Management;
• Experience in early clinical development.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
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Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.