Job title: Senior Clinical Outcomes Assessment (COA) Lead
- Location: Cambridge, MA or Morristown, NJ
Main responsibilities:The
Senior COA Lead is accountable for the definition of COA endpoint strategies and responsible for the conduct of related activities in relation to specific programs, assets or indications. The scope evolves as the COA Lead gains experience in role and demonstrates ability to take more in quantity (Therapeutic Area (TA) portfolio), impact (primary and key secondary endpoints) and exposure (strategic assets or indications).
In addition to serving as COA Lead on a portfolio of programs, the
Senior COA Lead provides expertise and strategic input in the COA team and beyond. He/she also ensures alignment of COA strategies and activities to:
- External standards (eg PFDD)
- Internal organization and priorities
- Trends in environment and competition
The Senior COA Lead actively participates in the regulatory and commercial dynamic specific to TA, defines and communicates the TA strategic framework, including Core Outcomes Sets and Digital endpoint strategy, provides guidance and support to the COA scientists.
The Senior COA Lead is accountable for scientific quality of activities and deliverable in their defined scope. This includes coaching less experienced COA scientists, acting as referral level whenever needed, leading and delivering internal educational programs, reviewing documents, representing the COA team in Sanofi asset and indication strategy meeting, as well as in FDA meetings on invitation.
The Senior COA Lead also takes direct accountability of some assets with support of COA scientist.
Expertise: The Senior COA Lead delivers senior expertise across the team in one or several methodologies (e.g. Psychometrics, Preference studies, Qualitative Research, Regulatory perspective and Endpoint definition...).
Innovation: The Senior COA Lead takes accountability of some strategic transversal projects, with support from COA Lead.
Exposure: The Senior COA Lead takes responsibilities and represent the COA team in cross-functional initiatives (e.g. with CSO, EDO, DBM).
The Senior COA Lead represents Sanofi in consortia and pre-competitive initiatives (e.g. C-Path).
About YouMinimum Qualifications- Master's Degree in relevant field
- 5 years experience in COA in either Pharma/CRO/Academic/Consultancy settings
Preferred Qualifications- Proven track record from scientific publications in core COA disciplines such COA data analyses and/or creation or validation of new COAs and/or COA endpoint strategy implementation
- Knowledge of the drug development process and the regulatory (FDA, EMA, local agencies) and payer (EUnetHTA, NICE, HAS, G-BA, other local agencies) environments.
- Appetite for innovation and change management.
- Ability to interact and manage external and internal networks
The salary range for this position is:
$178,500.00 - $257,833.33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
