P2430 - (Associate) Principal Clinical Pharmacologist

vor 21 Stunden

Lausanne, Schweiz Debiopharm Vollzeit

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. At Debiopharm, you will be at the forefront of the fight against cancer and infectious diseases through working on innovative medicines for patients. 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

(Associate) Principal Clinical Pharmacologist

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 include:

  • 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 interactions, 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 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 project completion.
  • 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 in scientific communication and events.
  • As part of Debiopharm’s model, contribute to the In & Out licensing activities or external fundraising activities.

Minimum Requirements:

  • PhD (PharmD is a plus) in Life sciences, pharmacokinetics, clinical pharmacology, or a related discipline.
  • At least 7 years of 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.
  • Excellent knowledge of GCP, GCLP, GLP, and relevant regulatory guidelines.
  • Experience in Oncology is an asset.
  • You are accustomed to working in cross-functional teams and fast-paced environments.
  • Team player, looking to tackle challenges together with your team.
  • Excellent communication skills in English (oral and written); French is an asset.

Debiopharm offers employees:

  • International, highly dynamic environment with a long-term vision.
  • Cross-functional collaboration at the forefront of the most advanced scientific developments in oncology and the anti-bacterial industry.
  • 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 Equal-Pay certified, we ensure offering all our employees the same opportunities.
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