Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail. 

This job offer is accessible to all, regardless of gender. 

Job title: Clinical Outcome Assessment (COA) Lead

Location: Gentilly

About the job

Our Team:

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 methodsThe COA team is part of Sanofi’s Global Research and Development (R&D), and reports into the Patient-Informed Development & Health Value Translation (PID&HVT) departmentConsultation with regulators and key opinion leaders is commonExample 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 COAsInternal customers include primarily Research and Development (R&D), Health Economics and Value Assessment (HEVA), and also Medical Affairs, Market Access, Biostatistics, and Commercial

Main 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).

He/She is expected to be able to:

Contribute to the Target Value Proposition with respect to patient-centric outcomes value messagingContribute to a successful strategy for innovative product by an optimized COA endpoint strategy aligned with Sanofi’s Best In Class/First In Class approachGenerate a comprehensive understanding of a disease and treatment paradigm through primary and secondary researchAdvise 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 disseminationManage 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

Specific role activities for a COA Lead also include advanced activities:

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 partnersMentor more junior COA scientists, share specific knowledge and expertise with the COA team; provide direction and delegate specific tasks to associate COA scientistImplement new methodologies and promote innovative approachesDefine or update overarching approach and framework to COA endpoints strategies in strategic area (eg. Oncology, I&I, rare diseases)

About you

 

COA Lead qualifications, experience and skills needed:

Experience ideally expected (indicative):

Relevant experience in COA in Pharma/CRO/Consultancy: ideally 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 implementationKnowledge of the drug development process and the regulatory (FDA, EMA, local agencies) and payer (EUnetHTA, NICE, HAS, G-BA, other local agencies) environment

 

Soft and technical skills:

Strong analytical and synthesis skills of qualitative and quantitative dataAccountability and hands-on mindset, autonomy and sense of initiativeGood interpersonal and communication skills, both written and oralAbility to manage multiple priorities and projects, and balance workload and timelines

 

Education:

Relevant advanced academic degree (e.g. doctorate or master degree in psychology, anthropology, sociology, public health, epidemiology, psychometrics, clinical research, physiotherapy, pharmacy, medicine, biostatistics)

 

Languages: 

Professional English fluency (written and spoken)

Pursue progress. Discover extraordinary. 

 

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.  

  

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.  
  

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!  

#LI-FRA

#LI-Hybrid

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!