Clinical Outcomes Assessment Lead - Cambridge - Sanofi SA

Description

Job Title

Clinical Outcomes Assessment Lead

Location

Cambridge, MA; Morristown, NJ

About The Job

Join the engine of Sanofi's mission — where deep immunoscience meets bold, AI‑powered research. In R&D, you'll drive breakthroughs that could turn the impossible into possible for millions.

Our Team

• 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's Global Research and Development (R&D), and reports into the Patient‑Informed Development & Health Value Translation (PID&HVT) 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 instrument; the development and validation of new COA instruments; the development of briefing books or dossiers for regulatory consideration of COAs…
• Internal customers include primarily Research and Development (R&D), Health Economics and Value Assessment (HEVA), and also Medical Affairs, Market Access, Biostatistics, and Commercial.

About Sanofi

We're an R&D‑driven, AI‑powered biopharma company committed to improving people's 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 people's lives.

Main Responsibilities

The 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 the role and demonstrates ability to take more in quantity (TA portfolio), impact (primary and key secondary endpoints) and exposure (strategic assets or indications).

He/She Is Expected To Be Able To

• Contribute to the Target Value Proposition with respect to patient‑centric outcomes value messaging
• Contribute to a successful strategy for innovative product by an optimized COA endpoint strategy aligned with Sanofi's Best In Class / First In Class approach
• Generate a comprehensive understanding of a disease and treatment paradigm through primary and secondary research
• Advise on the use and/or development of Fit‑for‑Purpose COA instruments in clinical research projects; including gap analyses, implementation, statistical analyses, psychometric validation and dissemination
• Manage the qualitative and quantitative research projects to close the validation gap(s) on the selected COA instruments (including vendor management)
• Prepare the scientific documents (reports, regulatory documents, publications,…) for internal and external communication

Specific role activities for a COA Lead also include advanced activities

• Leads specific internal organizational initiatives, within COA and PID‑HVT (eg. RACI, templates, guidance)
• Advocate for the role of quantitative and qualitative COA across Sanofi, participate in creating and delivering education on COAs for internal business partners
• Mentor more junior COA scientists, share specific knowledge and expertise with the COA team; provide direction and delegate specific tasks to associate COA scientist
• Implement new methodologies and promote innovative approaches.
• Define or update overarching approach and framework to COA endpoints strategies in strategic area (eg Oncology, I&I, rare diseases)

About You

COA Lead qualifications, experience and skills needed

Experience Ideally Expected (indicative)

• Relevant experience in COA in Pharma/CRO/Consultancy: ideally proven track record from scientific publications in core COA disciplines such as 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) environment

Soft And Technical Skills

• Strong analytical and synthesis skills of qualitative and quantitative data
• Accountability and hands‑on mindset, autonomy and sense of initiative
• Good interpersonal and communication skills, both written and oral
• Ability to manage multiple priorities and projects, and balance workload and timelines

Education

• Relevant advanced academic degree (e.g. doctorate or master degree in psychology, anthropology, sociology, public health, epidemiology, psychometrics, clinical research, physiotherapy, pharmacy, medicine, biostatistics…)

Languages

• Professional English fluency (written and spoken)

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 it's 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.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and affirmative action employers committed to a culturally diverse 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, sexual orientation, disability, veteran or 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.