Clinical Outcome Assessment Lead

Overview

Join to apply for the Clinical Outcome Assessment Lead role at Sanofi . Location: Gentilly. Grade: L3-2. 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 COAs and other methods. The COA team is part of Sanofi’s Global Research and Development (R&D) and reports into the PID&HVT department. Regular interaction with regulators and key opinion leaders is common.

The goal is to develop, validate and implement COA instruments and related strategies across programs to support clinical development and regulatory submissions. This description preserves the content language and intent while presenting it in a clean, structured format.

Main Responsibilities

• The COA Lead is accountable for the definition of COA endpoint strategies and for conducting related activities in relation to specific programs, assets or indications. The scope evolves with experience in role and the portfolio.
• Contribute to a successful strategy for an 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 qualitative and quantitative research projects to close validation gaps on the selected COA instruments (including vendor management).
• Prepare scientific documents (reports, regulatory documents, publications, etc.) for internal and external communication.
• Lead internal organizational initiatives within COA and PID-HVT (e.g., RACI, templates, guidance).
• Mentor more junior COA scientists, share knowledge, provide direction and delegate tasks to associate COA scientists.
• Implement new methodologies and promote innovative approaches.
• Define or update overarching approaches and frameworks to COA endpoint strategies in strategic areas (e.g., Oncology, I&I, rare diseases).

You Are Expected To

• Contribute to the Target Value Proposition with respect to patient-centric outcomes value messaging.
• Contribute to a successful strategy for an innovative product by an optimized COA endpoint strategy aligned with the Best In Class/First In Class approach.
• Generate a comprehensive understanding of disease and treatment paradigms through research.

About You

Experience ideally expected (indicative)

• Relevant experience in COA in Pharma/CRO/Consultancy with a 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 environments (EUnetHTA, NICE, HAS, G-BA, other local agencies).

Soft And Technical Skills

• Strong analytical and synthesis skills of qualitative and quantitative data.
• Accountability and hands-on mindset, autonomy and 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’s degree in psychology, anthropology, sociology, public health, epidemiology, psychometrics, clinical research, physiotherapy, pharmacy, medicine, biostatistics, etc.).

Languages

• Professional English fluency (written and spoken).

Equality and Inclusion

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 or other characteristics protected by law.

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Seniority level: Mid-Senior level

Employment type: Full-time

Job function: Health Care Provider

Industries: Pharmaceutical Manufacturing