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Principal Clinical Pharmacologist

Employer
RBW Consulting
Location
Switzerland
Salary
Competitive salary and benefits.
Start date
11 Nov 2019
Closing date
11 Dec 2019

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Job Details

Responsible for the scientific aspects of clinical pharmacology assessments in oncology trials of assigned projects, including pharmacometrics (PK, PK/PD, Exposure/Response), management of drug-drug interactions and QT prolongation risk evaluation; and of assigned clinical pharmacology studies.

Collaborates with collaborates with cross functional teams to ensure appropriate study designs are achieved for successful implementation of data analyses and accomplishment of intended study outcomes.

Determine clinical dose selection and dose adjustment.

Responsible for authoring and reviewing documentation intended for regulatory submissions, including the relevant sections of INDs and NDAs.

Responsible for identifying, overseeing and managing external vendors and consultants supporting the clinical pharmacology function.

Liaises with KOLs and academic collaborators on state of the art clinical pharmacology science and methodology.

Ensures the successful preparation and presentation of all internal and external documentation relating to clinical pharmacology.

 

Your profile:

  • PharmD with a PhD or a specialization in clinical pharmacology or pharmacokinetics
  • Minimum 5 years industry experience.
  • Proven track-record in early clinical phases of drug development, clinical pharmacology and/or contribution to drug development programs
  • Hands-on experience with PK and PK/PD data analysis (proficiency in Phoenix WinNonLin; good understanding of population PK, PK/PD, Modeling & Simulation techniques)
  • Experience contributing to regulatory documentation and answering health authority questions.
  • Oncology experience is desirable.
  • Excellent leadership, management, collaboration, communication and decision making skills.

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