Senior Clinical Outcomes Assessment (COA) Lead

Role Summary

Senior Clinical Outcomes Assessment (COA) Lead based in Cambridge, MA or Morristown, NJ. Responsible for defining COA endpoint strategies and leading related activities across programs, assets or indications. Provides strategic input to the COA team and aligns COA strategies with external standards and internal priorities, while coaching less experienced scientists. Represents the COA team in asset and indication strategy meetings and, when invited, FDA meetings. Takes accountability for some assets with COA scientist support and contributes to Core Outcomes Sets and Digital endpoint strategy.

Responsibilities

• The 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 (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 COA team and beyond. He/she also ensures alignment of COA strategies and activities to 1) external standards (eg PFDD) 2) internal organization and priorities and 3) 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 (eg 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 (eg with CSO, EDO, DBM). The Senior COA Lead represents Sanofi in consortia and pre-competitive initiatives (eg C-Path)

Qualifications

• 5+ years relevant experience in COA in Pharma/CRO/Consultancy
• Ideally proven track record from scientific publications in core COA disciplines such as 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) environment

Education

• Relevant advanced academic degree (e.g. doctorate or masters 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