Principal Scientist, Clinical Pharmacology
Debiopharm Group
Lausanne, Vaud, Switzerland
vor 14 Std.

Description

Debiopharm Group™ is a Swiss-based global biopharmaceutical group of five companies active in the development and manufacture of drugs and diagnostics tools.

Debiopharm focuses on developing prescription drugs that target unmet medical needs. The group in-licenses and develops promising drug candidates.

The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide.

For our Clinical Pharmacology & Drug Metabolism team in the Research and Development department based in Lausanne we are looking for a :

Principal Scientist, Clinical Pharmacology

100% - permanent contract)

In this role, you will be responsible for the clinical pharmacology program of assigned Debiopharm’s projects, leveraging state-

of-the-art PK and PK / PD methodologies.

Your main responsibilities :

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 from conception to final report, including first-

in-human studies (SAD, MAD), bioequivalence, food effect, drug-drug interactions, TQT, special populations PK and ADME studies.

Collaborates with Medical Science, Translational Science, Clinical Safety, Data Management & Biostatistics, Clinical Operations and Regulatory functions to ensure appropriate study designs are achieved for successful implementation of data analyses and accomplishment of intended study outcomes.

Determine, in collaboration with the relevant functions within Research & Development, clinical dose selection and dose adjustment.

Be a member of the project team and work in a collaborative and proactive way in a matrix environment.

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.

Identifies and communicates potential project hurdles, suggests solutions and establishes priorities and contingency plans.

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,
  • At least 5-8 years of direct experience in Biotech / Pharmaceutical industry,
  • Proven track-record in early clinical phases of drug development, clinical pharmacology, clinical research concepts and practices, and / or contribution to drug development programs that resulted in one or more marketed drugs,
  • Hands-on experience with PK and PK / PD data analysis (proficiency in Phoenix WinNonLin; good understanding of population PK, PK / PD, Modeling & Simulation techniques)
  • Hands-on experience in authoring regulatory documentation (experience in attending regulatory meetings a plus),
  • Experience in clinical pharmacology programs of oncology drugs (experience in pediatric trials or Asian trials a plus),
  • Excellent leadership, management, collaboration, communication and decision making skills.
  • Debiopharm can offer you :

  • 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
  • The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.
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