Clinical Outcome Assessment Lead

Clinical Outcome Assessment Lead

Sanofi is seeking a Clinical Outcome Assessment (COA) Lead to join its Global Research and Development (R&D) department, specifically within the Patient-Informed Development & Health Value Translation (PID&HVT) unit. This role is pivotal in integrating the patient's perspective into clinical research by utilizing Clinical Outcome Assessments (COAs) and other relevant methods. The position involves frequent collaboration with international affiliates, requiring professional English fluency.

About the COA Team

The COA team plays a crucial role in clinical research by incorporating patient and other subjective perspectives. Their activities include developing disease conceptual models, selecting and psychometrically assessing COA instruments, developing new COA instruments, and preparing regulatory dossiers. Internal clients span across R&D, Health Economics and Value Assessment (HEVA), Medical Affairs, Market Access, Biostatistics, and Commercial departments.

About Sanofi

Sanofi is a global healthcare company driven by R&D and powered by AI, dedicated to improving lives through scientific innovation. With a deep understanding of the immune system, Sanofi develops medicines and vaccines that impact millions worldwide. The company fosters an environment where employees can grow their careers, explore opportunities, and push the boundaries of what's possible.

Main Responsibilities

The COA Lead is accountable for defining COA endpoint strategies and overseeing their execution for specific programs, assets, or indications. The scope of responsibility expands with the COA Lead's experience, encompassing a larger portfolio, greater impact on primary and key secondary endpoints, and strategic assets or indications.

You Are Expected To

• Contribute to the Target Value Proposition with patient-centric outcomes messaging.
• Develop an optimized COA endpoint strategy aligned with Sanofi’s Best In Class/First In Class approach for innovative products.
• Gain a comprehensive understanding of disease and treatment paradigms through research.
• Advise on the use and development of Fit-for-Purpose COA instruments, including gap analyses, implementation, statistical analyses, psychometric validation, and dissemination.
• Manage qualitative and quantitative research projects to validate selected COA instruments, including vendor management.
• Prepare scientific documents for internal and external communication.

Specific Role Activities

• Lead internal organizational initiatives within COA and PID&HVT.
• Advocate for quantitative and qualitative COA across Sanofi and provide educational support.
• Mentor junior COA scientists and share expertise.
• Implement new methodologies and promote innovative approaches.
• Define or update overarching strategies for COA endpoints in specific therapeutic areas.

About You

The ideal candidate will have:

• Relevant experience in COA within Pharma, CRO, or Consultancy, with a proven track record in COA data analysis, instrument development/validation, or endpoint strategy implementation.
• Knowledge of the drug development process and regulatory/payer environments (FDA, EMA, EUnetHTA, NICE, etc.).

Soft and Technical Skills

• Strong analytical and synthesis skills for qualitative and quantitative data.
• Accountability, hands-on mindset, autonomy, and initiative.
• Excellent interpersonal and communication skills (written and oral).
• Ability to manage multiple priorities, projects, workload, and timelines.

Education and Languages

• Relevant advanced academic degree (e.g., doctorate or master’s in psychology, public health, psychometrics, clinical research, etc.).
• Professional English fluency (written and spoken).

Key skills/competency

• Clinical Outcome Assessment
• COA Lead
• Patient-Centric Outcomes
• COA Endpoint Strategy
• Psychometric Validation
• Drug Development Process
• Regulatory Affairs
• Qualitative Research
• Quantitative Research
• Sanofi