Principal Clinical Pharmacologist

Principal Clinical Pharmacologist

Debiopharm Group

Lausanne, Switzerland

In this role, you will be the leader for developing the clinical pharmacology scientific strategy for assigned projects in Oncology and/or Infectious diseases. To that aim, you will manage, conduct and supervise clinical pharmacology activities to add value, support, and accelerate the development of Debiopharm’s innovative medicine.

Your responsibilities will be but not limited to:

• Work in close collaboration with the project team and develop the clinical pharmacology strategy for assigned projects in Oncology or Infectious diseases
• Manage the clinical pharmacology activities of assigned projects, by contributing to the design of clinical pharmacology studies (SAD/MAD PK, bioequivalence, food effect, drug-drug inter- actions, PK in special populations, …)
• In collaboration with the pharmacometricians, elaborate the pharmacometrics strategy and organize the pharmacometrics activities for the assigned projects
• Be a member of the Clinical Trial team, contribute to the protocol writing and manage the PK and PK/PD analyses (noncompartmental analyses and modeling approaches) and reporting; manage the risk of food-drug interactions and drug-drug interactions regarding concomitant medications.
• Manage the outsourced activities, from provider selection until completion of project
• Prepare the clinical pharmacology and pharmacometrics documentation to support regulatory or other cross-functional activities; may participate in interactions with Health Authorities
• Contribute and participate to scientific communication and events
• As part of Debiopharm’s model, contribute to the In & Out licensing activities or external fund- raising activities

Your profile:

• PhD (PharmD is a plus) in Life sciences, pharmacokinetics, clinical pharmacology, or a related discipline
• At least 7-year experience in clinical pharmacology within Translational R&D and early clinical phases of drug development
• Expertise in Pharmacometrics such as Non-Compartmental PK analysis, Population PK/PD, Modeling & Simulation
• Excellence knowledge of GCP, GCLP, GLP, and relevant regulatory guidelines
• Experience in Antibody Drug Conjugate development is an asset
• You are used in working in cross-functional team and fast-paced environment
• Team player, looking to tackle challenges together with your team
• Excellent communication skills in English (oral and written), French is an asset