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Pharmacometrics Lead
vor 2 Monaten
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 develop innovative therapies and act as a bridge between disruptive discovery products and patient access in international markets.
Job SummaryWe are seeking a highly skilled Pharmacometrics Lead to join our Clinical Pharmacology and Pharmacometrics Unit organization based at our Headquarters in Lausanne. As a key member of our team, you will be responsible for developing the modeling and simulation strategy for projects in Oncology and Antibiotics, leveraging state-of-the-art PK and PK/PD methodologies, pharmacometry, and Quantitative System Pharmacology (QSP).
Key Responsibilities- Implement innovative quantitative methods to analyze non-clinical and clinical data by 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.
- Elaborate 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.
- 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.
- Oversee the management of pharmacometrics activities of assigned projects, directly or through supervision of another pharmacometrician or external vendors, in compliance with regulatory guidelines.
- Prepare pharmacometrics documentation to support regulatory or other cross-functional activities; may participate in interactions with Health Authorities.
- Contribute to scientific communications and events.
- As part of Debiopharm's model, contribute to In & Out licensing activities.
- 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 (NONMEM, Monolix, etc.); knowledge of PBPK modeling software (e.g., SimCYP, PK-Sim, Gastro-Plus) is an asset.
- In-depth understanding of pharmacology and pharmacokinetic concepts, as well as preclinical and clinical development.
- At least 7 years of experience in pharmacometrics within Translational R&D and early clinical phases of drug development; experience in oncology; antibiotics is an asset.
- Knowledge of GCP, GCLP, and relevant regulatory guidelines.
- You are used to working in cross-functional teams and fast-paced environments.
- Team player, looking to tackle challenges together with your team.
- Excellent presentation capabilities and communication skills in English (oral and written); French is an asset.
- 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 industries.
- Exposure to a wide variety of areas and functions within clinical development and the pharmaceutical industry.
- Participation in a company where innovation, people, and entrepreneurship are the fundamental keys to success.
- Proud to be an Equal-Pay certified company, ensuring equal opportunities for all employees.
