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Clinical Outcome Assessment Lead

Sanofi US

Lyon
Vor Ort
EUR 65.000 - 85.000
Vor 20 Tagen
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Ähnliche Jobs:

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Clinical Outcome Assessment Lead
Sanofi US
Lyon
Vor Ort
EUR 65.000 - 85.000
Vollzeit
Vor 20 Tagen

Zusammenfassung

Une entreprise biopharmaceutique internationale recherche un Clinical Outcome Assessment Lead pour définir des stratégies d'endpoint COA et gérer des projets de recherche au sein d'une équipe innovante. Une expérience pertinente en COA et des compétences en communication sont indispensables. Le lieu de travail est à Gentilly, en France, dans un environnement dynamique et collaboratif.

Qualifikationen

  • Expérience pertinente en COA dans l'industrie pharmaceutique ou CRO.
  • Connaissance du processus de développement de médicaments et des réglementations.
  • Capacité à gérer plusieurs priorités et projets.

Aufgaben

  • Définir des stratégies d'endpoint COA pour des programmes spécifiques.
  • Gérer des projets de recherche qualitative et quantitative.
  • Préparer des documents scientifiques pour communication interne et externe.

Kenntnisse

Analyse des données qualitatives et quantitatives
Autonomie et esprit d'initiative
Compétences en communication

Ausbildung

Diplôme avancé en psychologie, santé publique, ou recherche clinique
Jobbeschreibung

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 Lead

  • Location: Gentilly
  • Grade: L3-2
  • Hiring Manager: Benoit ARNOULD
About the job

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’s Global Research and Development (R&D), and reports into the Patient-Informed Development & Health Value Translation (PID&HVT) 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, etc.

Internal customers include primarily Research and Development (R&D), Health Economics and Value Assessment (HEVA), and also 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. Ready to get started?

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

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).

You are expected to
  • 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, etc.) 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 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)
About You
Experience ideally expected (indicative)
  • 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
Soft and technical skills
  • 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
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, etc.)
Languages
  • Professional English fluency (written and spoken)

Pursue Progress . Discover Extraordinary

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never‑been‑done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

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

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