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.
#J-18808-Ljbffr
Entreprise
INSTITUT DE RECHERCHE PIERRE FABRE SAS
Plateforme de publication
WHATJOBS
Offres pouvant vous intéresser
MASSY
il y a 1 jour
DREUX, 28
il y a 1 jour
MONTROUGE, 92
il y a 2 jours
PARIS, 75
il y a 2 jours