Job Title: Clinical Pharmacology & Pharmacometrics Specialist
Debiopharm is a privately-owned Swiss biopharmaceutical company dedicated to research in oncology and infectious diseases to improve patient outcomes and quality of life. As a pioneer in the development of innovative therapies, Debiopharm International SA aims to bridge disruptive discovery products and patient access in international markets.
You will be at the forefront of the fight against cancer and infectious diseases by working on innovative medicines for patients.
About the Role:
* 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.
* You will conduct pharmacometric analyses to add value, support, and accelerate the development of Debiopharm's innovative medicine.
Your Key Responsibilities:
* Conduct pharmacometric analyses of nonclinical and clinical data using innovative quantitative methods, modeling pharmacokinetics, pharmacodynamics, biomarkers, and clinical outcomes data with information on patient characteristics, knowledge of disease mechanisms, and disease progression 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, etc.) and solid hands-on experience in Population PK/PD modeling software (Monolix, NONMEM); knowledge of PBPK modeling software (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.