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DEDebiopharm

Principal Clinical Pharmacologist(m/w/x)

Lausanne
Full-timeOn-siteSenior

Designing clinical pharmacology studies for oncology/infectious diseases, including SAD/MAD PK and drug-drug interactions. PhD in life sciences or related discipline required. International and dynamic environment.

Requirements

  • PhD (PharmD is a plus) in Life sciences, pharmacokinetics, clinical pharmacology, or related discipline
  • Expertise in 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
  • Working in cross-functional teams and fast-paced environments
  • Team player, tackling challenges together with team
  • Excellent communication skills in English (oral and written)
  • Doctorate education

Tasks

  • Lead clinical pharmacology strategy for Oncology/Infectious diseases projects
  • Manage clinical pharmacology activities for assigned projects
  • Supervise clinical pharmacology activities to accelerate medicine development
  • Collaborate with project teams on clinical pharmacology strategy
  • Design clinical pharmacology studies (SAD/MAD PK, bioequivalence, food effect, drug-drug interactions, PK in special populations)
  • Develop pharmacometrics strategy with pharmacometricians
  • Organize pharmacometrics activities for assigned projects
  • Contribute to clinical trial protocols
  • Manage PK and PK/PD analyses (noncompartmental and modeling)
  • Manage reporting of PK and PK/PD analyses
  • Manage risk of food-drug and drug-drug interactions
  • Manage outsourced activities from provider selection to completion
  • Prepare clinical pharmacology and pharmacometrics documentation for regulatory support
  • Participate in Health Authority interactions
  • Contribute to scientific communication and events
  • Contribute to In & Out licensing activities
  • Contribute to external fund-raising activities

Work Experience

  • 7 years

Education

  • Doctoral / PhD

Languages

  • EnglishBusiness Fluent
  • FrenchBasic

Tools & Technologies

  • Non-Compartmental PK analysis
  • Population PK/PD
  • Modeling & Simulation
  • GCP
  • GCLP
  • GLP

Benefits

Informal Culture

  • International and dynamic environment
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