Senior Clinical Outcomes Assessment (COA) Lead

Senior Clinical Outcomes Assessment (COA) Lead Location: Cambridge, MA or Morristown, NJ About The Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. The remit of the Clinical Outcome Assessment (COA) team at Sanofi is to incorporate the patients perspective (and other subjective perspectives) into clinical research through the utilization of Clinical Outcome Assessments (COAs) and other methods. The COA team is part of Sanofi Global Research and Development (R&D), and reports into the Patient Driven Medicines Development (PDMD) department. Consultation with regulators and key opinion leaders is common. Example research activities for the COA team include the development of a disease conceptual model; the selection of COA instruments to measure specific concepts of interest; the psychometric assessment of the measurement properties of a COA instruments; the development and validation of new COA instruments; the development of briefing books or dossiers for regulatory consideration of COAs. Internal customers primarily include (R&D), Health Economics and Value Assessment (HEVA), Medical Affairs, Market Access, Biostatistics, and Commercial. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve peoples lives. Were also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? About Sanofi Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives. Main Responsibilities The Senior COA Lead is accountable for the definition of COA endpoint strategies and responsible for the conduct of related activities in relation to specific programs, assets or indications. The scope evolves as the COA Lead gains experience in role and demonstrates ability to take more in quantity (Therapeutic Area (TA) portfolio), impact (primary and key secondary endpoints) and exposure (strategic assets or indications). In addition to serving as COA Lead on a portfolio of programs, the Senior COA Lead provides expertise and strategic input in the COA team and beyond. He/she also ensures alignment of COA strategies and activities to External standards (eg PFDD) Internal organization and priorities Trends in environment and competition The Senior COA Lead actively participates in the regulatory and commercial dynamic specific to TA, defines and communicates the TA strategic framework, including Core Outcomes Sets and Digital endpoint strategy, provides guidance and support to the COA scientists. The Senior COA Lead is accountable for scientific quality of activities and deliverable in their defined scope. This includes coaching less experienced COA scientists, acting as referral level whenever needed, leading and delivering internal educational programs, reviewing documents, representing the COA team in Sanofi asset and indication strategy meetings, as well as in FDA meetings on invitation. The Senior COA Lead also takes direct accountability of some assets with support of COA scientist. Expertise The Senior COA Lead delivers senior expertise across the team in one or several methodologies (e.g. Psychometrics, Preference studies, Qualitative Research, Regulatory perspective and Endpoint definition). Innovation The Senior COA Lead takes accountability of some strategic transversal projects, with support from COA Lead. Exposure The Senior COA Lead takes responsibilities and represent the COA team in cross-functional initiatives (e.g. with CSO, EDO, DBM). The Senior COA Lead represents Sanofi in consortia and pre-competitive initiatives (e.g. C-Path). About You Minimum Qualifications Master's Degree in relevant field 5 years experience in COA in either Pharma/CRO/Academic/Consultancy settings Preferred Qualifications Proven track record from scientific publications in core COA disciplines such COA data analyses and/or creation or validation of new COAs and/or COA endpoint strategy implementation Knowledge of the drug development process and the regulatory (FDA, EMA, local agencies) and payer (EUnetHTA, NICE, HAS, G-BA, other local agencies) environments. Appetite for innovation and change management. Ability to interact and manage external and internal networks. Why Choose Us Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave. Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs. Help improve the lives of millions of people globally by making drug development quicker and more effective. Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science. Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here. #J-18808-Ljbffr BioSpace