Population PK/Pharmacometrics Modeler (CDI)
pierrefabre · Haute Garonne (31)
Description du poste
About the role
Pierre Fabre is looking for a Population PK/Pharmacometrics Modeler to join the Pharmacokinetics and Toxicology team in the Pierre Fabre R&D Pharma unit in Toulouse, supporting oncology programs at the Langlade site (Oncopole). The role sits within a pioneering company in full expansion.
Key responsibilities
- Lead population PK/PD modeling strategies and turn findings into clear recommendations for clinical development decisions
- Develop and qualify pharmacometrics analyses, focusing on population PK/PD and exposure-response analysis in oncology
- Drive the integration of pharmacometrics into drug development to mitigate risks early and support data-driven decisions
- Act as lead author and key contributor for pharmacometrics sections of clinical and regulatory documents (briefing books, clinical pharmacology summaries, responses to Health Authorities)
- Represent the team at global regulatory hearings, advisory committee meetings and other regulatory interactions
- Mentor colleagues on pharmacometrics methodology and contribute to scientific publications
Required profile
- PhD in Pharmaceutical Sciences, Pharmacometrics, Biostatistics, Applied Mathematics or a related quantitative field
- At least 5 years of hands-on population PK modeling experience in the pharmaceutical industry
- Extensive experience with advanced population PK/PD methodology
- Experience supporting regulatory submissions (IND, NDA/BLA) and preparing modeling sections
- Excellent English, written and spoken
- Preferred: proven impact on clinical or regulatory decisions, model-based meta-analysis or Bayesian trial design, oncology drug development knowledge, and experience with biologics, targeted therapies or ADCs
Required skills
- Expert-level NONMEM; Monolix is a plus
- R or Python for data manipulation, diagnostics and visualization
What we offer
- Remuneration and benefits package including incentives, profit-sharing and shareholding with matching contribution
- Health and provident insurance
- 16 days of RTT holidays plus 25 days of personal leave
- Public transport participation
- Teleworking up to 2 days a week according to company rules
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pierrefabre
Haute Garonne (31)
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