Senior Clinical Outcomes Assessment (COA) Lead
Sanofi
18 days ago
Remote friendly (Morristown, NJ)
United States
$178,500 - $257,833.33 USD yearly
Clinical Research and Development
Main Responsibilities:
- Define COA endpoint strategies and lead related activities for specific programs, assets, or indications.
- Provide expertise and strategic input across the COA team; ensure alignment of COA strategies/activities with external standards (e.g., PFDD), internal organization/priorities, and market/environment/competition trends.
- Participate in regulatory and commercial dynamics for the therapeutic area (TA); 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; 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 COA scientists).
- 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 team in cross-functional initiatives (e.g., with CSO, EDO, DBM) and pre-competitive initiatives (e.g., C-Path).
Qualifications:
- 5+ years relevant COA experience in Pharma/CRO/Consultancy.
- Proven track record via scientific publications in core COA disciplines (e.g., COA data analyses; creation/validation of new COAs; endpoint strategy implementation).
- Knowledge of drug development, regulatory (FDA, EMA, local agencies), 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 and manage external and internal networks.
Benefits:
- High-quality healthcare, prevention and wellness programs; at least 14 weeks’ gender-neutral parental leave.
- Define COA endpoint strategies and lead related activities for specific programs, assets, or indications.
- Provide expertise and strategic input across the COA team; ensure alignment of COA strategies/activities with external standards (e.g., PFDD), internal organization/priorities, and market/environment/competition trends.
- Participate in regulatory and commercial dynamics for the therapeutic area (TA); 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; 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 COA scientists).
- 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 team in cross-functional initiatives (e.g., with CSO, EDO, DBM) and pre-competitive initiatives (e.g., C-Path).
Qualifications:
- 5+ years relevant COA experience in Pharma/CRO/Consultancy.
- Proven track record via scientific publications in core COA disciplines (e.g., COA data analyses; creation/validation of new COAs; endpoint strategy implementation).
- Knowledge of drug development, regulatory (FDA, EMA, local agencies), 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 and manage external and internal networks.
Benefits:
- High-quality healthcare, prevention and wellness programs; at least 14 weeks’ gender-neutral parental leave.