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Population PK/Pharmacometrics Modeler- CDI- H/F

PECHBUSQUE, 31
il y a 1 jour

About the Company

Pierre Fabre is a leading dermo‑cosmetics and pharmaceutical company located in Occitanie, France.

Position Overview

Population PK/Pharmacometrics Modeler within the Pharmacokinetics and Toxicology team, supporting oncology programs at Langlade site, Oncopole, Toulouse.

Responsibilities

  • Lead population PK/PD modeling strategies and translate findings into recommendations for clinical development programs.
  • Develop and qualify pharmacometrics analyses with emphasis on population PK/PD modeling and exposure‑response analysis in oncology.
  • Drive and coordinate integration of pharmacometrics analyses in the drug development process to mitigate risks early and support data‑driven decision‑making.
  • Identify opportunities where pharmacometrics analyses can contribute to a better understanding of pharmacokinetics, pharmacodynamics, safety, and efficacy.
  • Serve as lead author and key contributor for pharmacometrics sections of clinical and regulatory documents (briefing books, summaries, responses to Health Authority questions).
  • Represent the team at global regulatory hearings/advisory committee meetings and other global regulatory interactions.
  • Mentor and guide colleagues on pharmacometrics methodology and contribute to scientific publication.

Qualifications

  • PhD in Pharmaceutical Sciences, Pharmacometrics, Biostatistics, Applied Mathematics, or a related quantitative field.
  • Minimum 5+ years of hands‑on population PK modeling experience in the pharmaceutical industry.
  • Expert‑level proficiency in NONMEM; familiarity with other mixed‑effects modeling tools (Monolix, etc.) is a plus.
  • Extensive experience with advanced population PK/PD methodology.
  • Strong programming skills in R or Python for data manipulation, exploratory analysis, diagnostics, and visualization.
  • Experience in supporting regulatory submissions (IND, NDA/BLA) including preparation of modeling sections and responding to health authorities.
  • Excellent interpersonal skills and ability to work in cross‑functional teams.
  • Excellent written and verbal skills in English.

Preferred Qualifications

  • Proven track record of delivering pharmacometrics analyses that influenced clinical development or regulatory decisions.
  • Experience with model‑based meta‑analysis, Bayesian trial design, or novel exposure‑response methods.
  • Understanding of oncology drug development is highly desirable.
  • Experience modeling multiple therapeutic modalities beyond small molecules (biologics, targeted therapies, ADCs) is a plus.

Benefits

  • Incentives, profit‑sharing, and Pierre Fabre shareholding with matching contribution.
  • Health and provident insurance.
  • 16 days of holidays (RTT) in addition to 25 days of personal holidays.
  • Public transport participation.
  • Teleworking up to 2 days a week (according to company rules).

Inclusion & Diversity

The company values diversity as a source of fulfillment, social balance and complementarity for its employees, and offers positions open to all, without restriction.

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Entreprise
INSTITUT DE RECHERCHE PIERRE FABRE SAS
Plateforme de publication
WHATJOBS
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