Clinical Outcome Assessment (COA) Lead

Sanofi•Morristown, NJ

1d•Onsite

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. 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. Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

Requirements

Bachelor's degree is required
Minimum 3 years of 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.

Nice To Haves

Master's degree is preferred (not mandatory), in fields of study such as Psychology, Anthropology, Sociology, Public Health, Epidemiology, Psychometrics, Clinical Research, Physiotherapy, Pharmacy, Medicine, Biostatistics, and other related disciplines.
Strong analytical and synthesis skills of qualitative and quantitative data.
Accountability and hands-on mindset, autonomy and sense of initiative.
Good interpersonal and communication skills, both written and oral.
Ability to manage multiple priorities and projects, and balance workload and timelines.

Responsibilities

Contribute to the Target Value Proposition with respect to patient-centric outcomes value messaging.
Contribute to a successful strategy for innovative product by an optimized COA endpoint strategy aligned with Sanofi’s Best In Class / First In Class approach.
Generate a comprehensive understanding of a disease and treatment paradigm through primary and secondary research.
Advise on the use and/or development of Fit-for-Purpose COA instruments in clinical research projects; including gap analyses, implementation, statistical analyses, psychometric validation and dissemination.
Manage the qualitative and quantitative research projects to close the validation gap(s) on the selected COA instruments (including vendor management).
Prepare the scientific documents (reports, regulatory documents, publications,...) for internal and external communication.
Leads specific internal organizational initiatives, within COA and PID-HVT (eg. RACI, templates, guidance).
Advocate for the role of quantitative and qualitative COA across Sanofi, participate in creating and delivering education on COAs for internal business partners.
Mentor more junior COA scientists, share specific knowledge and expertise with the COA team; provide direction and delegate specific tasks to associate COA scientist.
Implement new methodologies and promote innovative approaches.
Define or update overarching approach and framework to COA endpoints strategies in strategic area (eg Oncology, I&I, rare diseases).