Director, HEOR Clinical Outcomes Assessments (COA's)
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. Summary . The Director, HEOR, COA develops, implements and communicates COA e.g. Patient Reported Outcomes, PROs measurement strategies and plans in support of the Regeneron product portfolio. The Director provides COA expertise to Health Economics Outcomes Research HEOR product leads, Clinical, Regulatory Affairs and Commercial colleagues across Regeneron drug development programs. The Director reports to the Senior Director, HEOR, COA. Job Duties . Collaborates with Clinical Development, Regulatory Affairs and Commercial organizations to develop and implement COA measurement plans across clinical programs and studies to support product approval, labeling, patient access, and medical differentiation . Assesses literature and existing COAs, conducts gap analyses and expert interviews to inform COA measurement strategy . Identifies and selects/recommends appropriate COA measures . Leads development of COAs/modifies existing COAs, including patient concept elicitation, cognitive debriefing, psychometric validation . Ensures COAs are appropriately implemented in clinical trials, including reviewing relevant clinical protocol sections and conducting COA training at Investigator Meetings . Provides technical expertise in the analysis, reporting and dissemination of COA data . Produces COA/PRO evidence dossiers for regulatory submissions e.g. FDA, EMA . Advises on and contributes to COA/PRO sections of regulatory documents, including briefing documents and submissions . Interacts with regulatory agencies e.g. FDA, EMA regarding COA endpoints on behalf of Regeneron . Prepares and submits publications presenting COA data . Maintains awareness of scientific and regulatory developments within COA area and communicates information internally . Attends relevant governmental, professional and industry meetings/conferences . Provides training on COA-related topics across functional areas . Identifies and maintains successful research relationships with HEOR key opinion leaders and thought leaders . Collaborates with Alliance partners on HEOR plans, studies and deliverables . builds and maintains constructive and productive relationships across Alliance . Requirements . Strong technical expertise in design and implementation of COA/PRO measurements in clinical trials, including analysis and reporting of COA/PRO data . 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 . 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 . 5+ years pharma or consulting experience 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. To all agencies . Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. 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.