Switzerland
Posted 3 years ago
Key responsibilities
- Work in close collaboration with the project team and develop the clinical pharmacology scientific strategy for assigned projects in Oncology or Antibiotics
- 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 interactions, PK in special populations), planning and managing the pharmacometrics activities
- Be a member of the Clinical Study 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 with regard to concomitant medications.
- Manage the outsourced activities, from provider selection until completion of project
- Contribute and participate to scientific communication and events
- Prepare the clinical pharmacology and pharmacometrics documentation to support regulatory or other cross-functional activities; may participate in interactions with Health Authorities
- Contribute to the In & Out licensing activities or external fund-raising activities
Your profile
- PhD (PharmD is a plus) in Lifesciences, 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 Oncology 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
Job Features
Job Category | CLINICAL DEVELOPMENT |