Senior Clinical Outcomes Assessment Scientist

Sanofi; Gentilly; Hybride; EUR 80 000 - 100 000; Plein temps

Résumé du poste

A global healthcare company in Île-de-France seeks a Senior COA Lead to define COA endpoint strategies and ensure alignment with regulatory standards. The ideal candidate will have relevant experience in COA within the pharmaceutical sector, strong scientific expertise, and the ability to manage internal networks. Join us to innovate and impact patient outcomes.

Qualifications

• Relevant experience in COA in Pharma / CRO / Consultancy.
• Knowledge of drug development and regulatory environment.

Responsabilités

• Define COA endpoint strategies and conduct related activities.
• Ensure alignment of COA strategies to external standards.
• Participate in regulatory and commercial dynamics.
• Deliver scientific quality across activities and initiatives.

Connaissances

Accountability and hands-on mindset

Ability to interact and manage networks

Appetite for innovation and change management

Formation

Advanced academic degree in relevant fields

Description du poste

Job title : 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, etc.

Internal customers include primarily Research and Development (R&D), Health Economics and Value Assessment (HEVA), and Medical Affairs, Market Access, Biostatistics, and Commercial.

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).

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 1) external standards (e.g. PFDD); 2) internal organization and priorities; 3) 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 the scientific quality of activities and deliverables in their defined scope. This includes coaching less experienced COA scientists, acting as a 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 the support of a 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, etc.).
• Innovation: The Senior COA Lead takes accountability of some strategic transversal projects, with support from the COA Lead.
• Exposure: The Senior COA Lead takes responsibilities and represents 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).

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 :

• Accountability and hands‑on mindset, autonomy, and sense of initiative.
• Appetite for innovation and change management.
• Ability to interact and manage external and internal networks.

Education :

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

Pursue . Discover .

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never‑been‑done‑before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue and Discover – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

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Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.