Clinical Outcomes Assessment Lead
Company: Sanofi
Location: Cambridge
Posted on: March 13, 2026
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Job Description:
Job Title : Clinical Outcomes Assessment Lead Location:
Cambridge, MA, Morristown, NJ About the Job Join the engine of
Sanofis mission where deep immunoscience meets bold, AI-powered
research. In R&D, youll 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
Sanofis 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 instruments; 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: 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 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 (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 Sanofis
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 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. 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;
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. GD-SA LI-SA LI-Onsite vhd 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.
Keywords: Sanofi, Marthas Vineyard , Clinical Outcomes Assessment Lead, Science, Research & Development , Cambridge, Massachusetts
