Senior Clinical Outcomes Assessment (COA) Lead
Sanofi
August 26, 2026
Remote friendly (Cambridge, MA)
United States
$178,500 - $257,833.33 USD yearly
Clinical Research and Development
Main Responsibilities:
- Define COA endpoint strategies and oversee related activities for specific programs, assets, or indications (TA portfolio growth, endpoint impact, strategic exposure).
- Provide COA expertise and strategic input within the COA team and beyond; ensure COA strategy alignment with external standards (e.g., PFDD), internal priorities, and environment/competition trends.
- Participate in TA regulatory and commercial dynamics; define and communicate TA strategic framework including Core Outcomes Sets and Digital endpoint strategy; guide/support COA scientists.
- Ensure scientific quality of deliverables; coach less experienced COA scientists; lead internal educational programs; review key documents; represent COA team in asset/indication strategy meetings and FDA meetings (on invitation).
- Take direct accountability for some assets (with COA scientist support).
- Deliver senior expertise across methodologies (e.g., psychometrics, preference studies, qualitative research, regulatory perspective, endpoint definition).
- Lead some strategic transversal projects; represent COA team in cross-functional initiatives and consortia/pre-competitive initiatives (e.g., C-Path).
Qualifications:
- Minimum: Master’s degree in relevant field.
- Minimum: 5 years COA experience in Pharma/CRO/Academic/Consultancy.
Preferred:
- Publications and/or experience in COA data analyses and/or creation/validation of new COAs and/or COA endpoint strategy implementation.
- Knowledge of drug development and regulatory (FDA, EMA, local agencies) and payer environments (EUnetHTA, NICE, HAS, G-BA, others).
- Appetite for innovation/change management; ability to manage external/internal networks.
Benefits (if eligible):
- High-quality healthcare and prevention/wellness programs; at least 14 weeks’ gender-neutral parental leave.
- Define COA endpoint strategies and oversee related activities for specific programs, assets, or indications (TA portfolio growth, endpoint impact, strategic exposure).
- Provide COA expertise and strategic input within the COA team and beyond; ensure COA strategy alignment with external standards (e.g., PFDD), internal priorities, and environment/competition trends.
- Participate in TA regulatory and commercial dynamics; define and communicate TA strategic framework including Core Outcomes Sets and Digital endpoint strategy; guide/support COA scientists.
- Ensure scientific quality of deliverables; coach less experienced COA scientists; lead internal educational programs; review key documents; represent COA team in asset/indication strategy meetings and FDA meetings (on invitation).
- Take direct accountability for some assets (with COA scientist support).
- Deliver senior expertise across methodologies (e.g., psychometrics, preference studies, qualitative research, regulatory perspective, endpoint definition).
- Lead some strategic transversal projects; represent COA team in cross-functional initiatives and consortia/pre-competitive initiatives (e.g., C-Path).
Qualifications:
- Minimum: Master’s degree in relevant field.
- Minimum: 5 years COA experience in Pharma/CRO/Academic/Consultancy.
Preferred:
- Publications and/or experience in COA data analyses and/or creation/validation of new COAs and/or COA endpoint strategy implementation.
- Knowledge of drug development and regulatory (FDA, EMA, local agencies) and payer environments (EUnetHTA, NICE, HAS, G-BA, others).
- Appetite for innovation/change management; ability to manage external/internal networks.
Benefits (if eligible):
- High-quality healthcare and prevention/wellness programs; at least 14 weeks’ gender-neutral parental leave.