Senior Clinical Outcomes Assessment Scientist H/F Sanofi

Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l'international, l'anglais étant la langue de travail.

This job offer is accessible to all, regardless of gender.

Job title: Senior Clinical Outcomes Assessment Scientist

- Location: Gentilly

- Grade: L4

- Hiring Manager: Benoit ARNOULD

About the job

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 instruments; 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 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 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 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 meeting, 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, etc.)
- 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

Experience ideally expected (indicative):

- Relevant experience in COA in Pharma/CRO/Consultancy: ideally 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) 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 Progress. Discover Extraordinary.

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 Progress and Discover Extraordinary - 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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La diversité et l'inclusion sont les piliers de la manière dont Sanofi fonctionne et font partie intégrante des valeurs de la société. Nous respectons la diversité de nos collaborateurs, tout comme celle de leurs parcours et expériences. Afin de bénéficier de la richesse qu'apporte la diversité, Sanofi s'engage à donner l'exemple en matière d'inclusion et à favoriser un environnement de travail où les différences peuvent prospérer et contribuer à aider les patients à retrouver une vie meilleure.

Dans le cadre de son engagement diversité, Sanofi accueille et intègre des collaborateurs en situation de handicap.