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    About DebiopharmDebiopharm International SA is a privately-owned Swiss biopharmaceutical company dedicated to research and development in oncology and infectious diseases. Our mission is to improve patient outcomes and quality of life through innovative therapies.Job SummaryWe are seeking a highly skilled Senior Pharmacometrician to join our Clinical...

Senior Pharmacometrician

vor 2 Monaten


Lausanne, Waadt, Schweiz Debiopharm Vollzeit
About Debiopharm

Debiopharm International SA is a privately-owned Swiss biopharmaceutical company dedicated to research in oncology and infectious diseases to improve patient outcomes and quality of life. Our unique "development only" business model enables us to act as a bridge between innovative discovery products and patient access in international markets.

Job Summary

We are seeking a highly skilled Senior Pharmacometrician to join our Clinical Pharmacology and Pharmacometrics Unit at our Headquarters in Lausanne. As a key member of our team, you will contribute to the modeling and simulation strategy for projects in Oncology and Antibiotics, leveraging state-of-the-art PK and PK/PD methodologies.

Key Responsibilities
  • Conduct pharmacometric analyses of nonclinical and clinical data using innovative quantitative methods, modeling pharmacokinetics, pharmacodynamics, biomarkers, and clinical outcomes data to facilitate quantitative decision-making in support of projects.
  • Contribute to the elaboration and execution of PK/PD modeling and simulation strategies to support model-informed drug development in early to late clinical phases of oncology and antibiotics projects.
  • Manage pharmacometrics activities of assigned projects, directly or in collaboration with external vendors, in compliance with regulatory guidelines.
  • Collaborate with Clinical Pharmacology and relevant functions within Translational Medicine and Research & Development to support study design, dose selection, and optimization for small and large molecules under development.
  • Contribute to the preparation of pharmacometrics documentation to support regulatory or other cross-functional activities; may participate in interactions with Health Authorities.
  • Contribute and participate in scientific communications and events.
  • Support the In & Out licensing activities as part of Debiopharm's model.
Requirements
  • PhD or equivalent degree in pharmaceutical sciences, mathematics, statistics, engineering or similar disciplines with demonstrated expertise in pharmacometrics (population PK and PK/PD modeling, exposure-response analysis, disease progression models, clinical trial simulation).
  • Excellent programming skills (R, Python, …) and solid hands-on experience in Population PK/PD modelling softwares (Monolix, NONMEM); knowledge of PBPK modeling softwares (e.g.: SimCYP, PK-Sim, Gastro-Plus) is an asset.
  • In-depth understanding of pharmacology and pharmacokinetic concepts, as well as knowledge of preclinical and clinical development.
  • At least 3-5 years relevant experience within industry or academia; experience in oncology and/or antibiotics is an asset.
  • Knowledge of GCP, GCLP and relevant regulatory guidelines.
  • Ability to work independently while maintaining strong collaborations within cross-functional teams.
  • Strong organizational skills and ability to handle multiple tasks simultaneously.
  • Excellent presentation capabilities and communication skills in English (oral and written), French is an asset.
What We Offer
  • International, highly dynamic environment with a long-term vision.
  • Cross-functional collaboration at the forefront of the most advanced scientific developments in oncology and anti-bacterial industry.
  • Exposure to a wide variety of areas and functions within clinical development and the pharmaceutical industry.
  • Opportunity of personal development through specific trainings and attendance to scientific conferences.
  • Participation in a company where innovation, people and entrepreneurship are the fundamental keys to success.
  • Proud to be an Equal-Pay certified, we ensure offering to all our employees the same opportunities.