Principal Clinical Pharmacologist

vor 2 Stunden

Lausanne, Schweiz Debiopharm Vollzeit

Description

Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and bacterial infections in order to improving patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.

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

Principal Clinical Pharmacologist

At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases, and you will have the opportunity to work on new innovative medicines for patients. Efficacy is our mode of action, saving lives our collective target.

In this role, you will develop the clinical pharmacology and pharmacometrics scientific strategy for assigned projects in Oncology and Antibiotics and manage clinical pharmacology and pharmacometrics activities to add value, support, and accelerate the development of Debiopharm’s innovative medicine. You will also represent the Clinical Pharmacology & Drug Metabolism function in Project Teams.

**Your responsibilities will be but not limited to**:
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
As part of Debiopharm’s model, contribute to the In & Out licensing activities or external fund-raising activities
**Requirements**:
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 in 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**:
An international and highly dynamic environment, with a long term vision.
The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry and be exposed to many areas within clinical development and the pharmaceutical industry.
The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.

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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