Clinical Outcomes Assessment Lead
Sanofi
9 hours ago
Remote friendly (Morristown, NJ)
United States
Clinical Research and Development
Main Responsibilities
- Define COA (Clinical Outcome Assessment) endpoint strategies and lead related activities for specific programs, assets, or indications.
- Contribute to patient-centric outcomes value proposition messaging.
- Develop and support an optimized COA endpoint strategy aligned with Best In Class / First In Class approaches.
- Build a comprehensive understanding of disease and treatment paradigms through primary and secondary research.
- Advise on the use and/or development of fit-for-purpose COA instruments, including gap analyses, implementation, statistical analyses, psychometric validation, and dissemination.
- Manage qualitative and quantitative research projects to close COA validation gaps (including vendor management).
- Prepare scientific documents (reports, regulatory documents, publications) for internal and external communication.
Advanced / Leadership Activities
- Lead internal initiatives within COA and PID-HVT (e.g., RACI, templates, guidance).
- Advocate for quantitative and qualitative COA; create/deliver COA education for internal partners.
- Mentor junior COA scientists; provide direction and delegate tasks.
- Implement new methodologies and promote innovative approaches.
- Define/update overarching COA endpoint strategy approaches for strategic areas (e.g., Oncology, I&I, rare diseases).
Qualifications / Experience
- Relevant COA experience in Pharma/CRO/Consultancy, with a track record via scientific publications and/or COA data analyses and/or creation/validation of new COAs and/or endpoint strategy implementation.
- Knowledge of drug development process and regulatory (FDA, EMA, local agencies) and payer (EUnetHTA, NICE, HAS, G-BA, other local agencies) environment.
Skills
- Strong analytical and synthesis skills with qualitative and quantitative data.
- Accountability, hands-on mindset, autonomy, and initiative.
- Strong written and oral communication and interpersonal skills.
- Ability to manage multiple priorities and projects while balancing workload and timelines.
Education
- Relevant advanced degree (e.g., doctorate or master’s in psychology, anthropology, sociology, public health, epidemiology, psychometrics, clinical research, physiotherapy, pharmacy, medicine, biostatistics, etc.).
Languages
- Professional English fluency (written and spoken).
- Define COA (Clinical Outcome Assessment) endpoint strategies and lead related activities for specific programs, assets, or indications.
- Contribute to patient-centric outcomes value proposition messaging.
- Develop and support an optimized COA endpoint strategy aligned with Best In Class / First In Class approaches.
- Build a comprehensive understanding of disease and treatment paradigms through primary and secondary research.
- Advise on the use and/or development of fit-for-purpose COA instruments, including gap analyses, implementation, statistical analyses, psychometric validation, and dissemination.
- Manage qualitative and quantitative research projects to close COA validation gaps (including vendor management).
- Prepare scientific documents (reports, regulatory documents, publications) for internal and external communication.
Advanced / Leadership Activities
- Lead internal initiatives within COA and PID-HVT (e.g., RACI, templates, guidance).
- Advocate for quantitative and qualitative COA; create/deliver COA education for internal partners.
- Mentor junior COA scientists; provide direction and delegate tasks.
- Implement new methodologies and promote innovative approaches.
- Define/update overarching COA endpoint strategy approaches for strategic areas (e.g., Oncology, I&I, rare diseases).
Qualifications / Experience
- Relevant COA experience in Pharma/CRO/Consultancy, with a track record via scientific publications and/or COA data analyses and/or creation/validation of new COAs and/or endpoint strategy implementation.
- Knowledge of drug development process and regulatory (FDA, EMA, local agencies) and payer (EUnetHTA, NICE, HAS, G-BA, other local agencies) environment.
Skills
- Strong analytical and synthesis skills with qualitative and quantitative data.
- Accountability, hands-on mindset, autonomy, and initiative.
- Strong written and oral communication and interpersonal skills.
- Ability to manage multiple priorities and projects while balancing workload and timelines.
Education
- Relevant advanced degree (e.g., doctorate or master’s in psychology, anthropology, sociology, public health, epidemiology, psychometrics, clinical research, physiotherapy, pharmacy, medicine, biostatistics, etc.).
Languages
- Professional English fluency (written and spoken).