About Debiopharm
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 an innovative organization, we aim to develop groundbreaking therapies via our unique "development only" business model, acting as a bridge between pioneering discovery products and patient access in international markets.
At Debiopharm, you will be at the forefront of the fight against cancer and infectious diseases through working on innovative medicines for patients. Our team of experts shares a common goal: to innovate, impact, and grow.
Clinical Pharmacology & Pharmacometrics Unit
We are seeking a Senior Pharmacometrician for our Clinical Pharmacology & Pharmacometrics Unit organization based at our Headquarters in Lausanne.
Job Responsibilities:
* Conduct pharmacometric analyses of nonclinical and clinical data using cutting-edge quantitative methods, incorporating pharmacokinetics, pharmacodynamics, biomarkers, and clinical outcomes data with information on patient characteristics, disease mechanisms, and disease progression to inform decision-making in support of projects.
* Develop and execute PK/PD modeling and simulation strategies to support model-informed drug development in early to late clinical phases of oncology and antibiotics projects.
* Oversee pharmacometrics activities of assigned projects, either directly or in collaboration with external vendors, ensuring 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.
* Prepare pharmacometrics documentation to support regulatory or other cross-functional activities; participate in interactions with Health Authorities.
* Promote scientific communications and events.
* Support In & Out licensing activities as part of Debiopharm's model.
Requirements:
* Ph.D. 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 hands-on experience in Population PK/PD modelling software (Monolix, NONMEM); knowledge of PBPK modeling software (SimCYP, PK-Sim, Gastro-Plus) is beneficial
* In-depth understanding of pharmacology and pharmacokinetic concepts, as well as knowledge of preclinical and clinical development
* At least 3-5 years of relevant experience within industry or academia; experience in oncology and/or antibiotics is advantageous
* Familiarity with GCP, GCLP, and relevant regulatory guidelines
* Able 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; French is an asset
The use of external staffing agencies or recruiters requires prior approval from our Human Resources Department. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create any implied obligation on the part of Debiopharm.
Debiopharm will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions.