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