P2411 - Pharmacometrics Lead

Debiopharm is a privately-owned Swiss biopharmaceutical company committed to research in oncology and infectious diseases to improve patient outcomes and quality of life. Debiopharm International SA aims to develop innovative therapies via our unique “development only” business model, acting as a bridge between disruptive discovery products and patient access in international markets. Join our team at Debiopharm, where together, we innovate, we impact, and we grow.

For our Clinical Pharmacology & Pharmacometrics Unit organization based at our Headquarters in Lausanne, we are looking for a

In this role, you will be the leader 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). You will manage, conduct, and supervise pharmacometrics activities to add value, support, and accelerate the development of Debiopharm’s innovative medicine.

Your responsibilities will be but not limited to:

• Implement innovative quantitative methods to analyze non-clinical and clinical data by modeling pharmacokinetics, pharmacodynamics, biomarkers, and clinical outcomes data with information of 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 in order 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 the 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.
• As part of Debiopharm’s model, contribute to the In & Out licensing activities.

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 modeling software (NONMEM, Monolix, …); knowledge of PBPK modeling software (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 and 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.

The use of external staffing agencies or recruiters requires prior approval from our Human Resources Department. The Human Resources Department at Debiopharm requests external staffing agencies or recruiters not to contact Debiopharm employees or members of the Board of Directors directly in an attempt to present candidates.

Debiopharm will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions.

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