P2430 - (Associate) Principal Clinical Pharmacologist

vor 21 Stunden

Lausanne, Schweiz Debiopharm Vollzeit

Description
Debiopharm is privately-owned Swiss biopharmaceutical company committed to research in oncology and infectious diseases in order 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 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 fundraising activities
**Requirements**:
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 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

**Benefits**:
**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 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 an Equal-Pay certified, we ensure offering to all our employees the same opportunities
Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create any implied obligation on the part of Debiopharm.

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