Sanofi logo

Senior Clinical Outcomes Assessment (COA) Lead

Sanofi
18 days ago
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.
- 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 competitive/environmental trends.
- Participate in TA regulatory and commercial dynamics; define and communicate TA strategic framework, including Core Outcomes Sets and digital endpoint strategy; guide and support COA scientists.
- Ensure scientific quality of deliverables; coach less experienced COA scientists; lead internal educational programs and review documents; represent the COA team in asset/indication strategy meetings and FDA meetings (by invitation).
- Take direct accountability for some assets (with support of a COA scientist).
- Deliver senior expertise across one or more methodologies (e.g., psychometrics, preference studies, qualitative research, regulatory perspective, endpoint definition).
- Lead strategic transversal projects; represent COA in cross-functional initiatives and consortia/pre-competitive initiatives (e.g., C-Path).

Qualifications:
- 5+ years relevant COA experience in Pharma/CRO/Consultancy.
- Proven track record with COA publications and/or creation/validation of new COAs and/or implementation of COA endpoint strategy.
- Knowledge of drug development, regulatory (FDA/EMA/local) and payer environment (e.g., EUnetHTA, NICE, HAS, G-BA).
- Relevant advanced degree (e.g., doctorate or master’s in psychology, anthropology, sociology, public health, epidemiology, psychometrics, clinical research, physiotherapy, pharmacy, medicine, biostatistics).

Skills:
- Appetite for innovation and change management.
- Ability to interact with and manage external and internal networks.

Why Choose Us (Benefits):
- Health and wellbeing benefits, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.