Senior Clinical Outcomes Assessment (COA) Lead

Sanofi•Morristown, MA

11h•Hybrid

About The Position

The remit of the Clinical Outcome Assessment (COA) team at Sanofi is to incorporate the patients’ perspective (and other subjective perspectives) into clinical research through the utilization of Clinical Outcome Assessments (COAs) and other methods. The COA team is part of Sanofi Global Research and Development (R&D), and reports into the Patient Driven Medicines Development (PDMD) department. Consultation with regulators and key opinion leaders is common. Example research activities for the COA team include the development of a disease conceptual model; the selection of COA instruments to measure specific concepts of interest; the psychometric assessment of the measurement properties of a COA instruments; the development and validation of new COA instruments; the development of briefing books or dossiers for regulatory consideration of COAs. Internal customers primarily include (R&D), Health Economics and Value Assessment (HEVA), Medical Affairs, Market Access, Biostatistics, and Commercial. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible.

Requirements

Master's Degree in relevant field
5 years experience in COA in either Pharma/CRO/Academic/Consultancy settings

Nice To Haves

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 .

Responsibilities

The Senior C OA 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.
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…).
The Senior COA Lead takes accountability of some strategic transversal projects, with support from COA Lead.
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).