P2604 - Principal Clinical Pharmacologist

Position

Vollzeit

Festanstellung

Senior

Wissenschaft & Forschung

Konditionen

Lausanne, Switzerland

Anforderungen

7+ J. Erfahrung

Doktortitel

EU/EFTA-Bewilligung

Skills

Food-drug interactionsPharmacokineticsGCPClinical PharmacologyPharmacometric analysisAntibody-Drug Conjugate (ADC)GLPClinical trialsRegulatory frameworksCommunication ProtocolsDrug-Drug Interaction AssessmentPK/PD modeling software

Sprachen

Englisch C1

Französisch

Beschreibung

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.

Aufgaben

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 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

Anforderungen

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

Vorteile

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 of being in a company in which innovation, people and entrepreneurship are the fundamentals of its success.

Unternehmen

Debiopharm

Biopharmaceuticals

Debiopharm is 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. Efficacy is our mode of action, saving lives our collective target. Join our team at Debiopharm where together, we innovate, we impact, and we grow.