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Clinical Pharmacology Scientist

Actalent

Posted on May 12, 2022 by Actalent

Basel, Switzerland
Research
Immediate Start
Annual Salary
Contract/Project

Clinical Pharmacology Scientist

A top Swiss pharmaceutical company in Basel is looking for an experienced Clinical Pharmacology Scientist to join their team. In close collaboration with the project's Clinical Pharmacologist (CP), the CP Scientist is responsible for overall planning, management, data evaluation and reporting of clinical pharmacology studies.

Tasks & Responsibilities:

  • Leading the evaluation of clinical pharmacology data (pharmacokinetics, pharmacodynamics, safety)
  • Interacting as required with operational staff and investigators, Data Management, Biostatistics and other partners
  • Leads the ongoing review of study data (eg PK, PD and safety) and reviews the data output for scientific and medical validity and consistency
  • Assists in the preparation of the clinical pharmacology component of the project specific Investigators Brochure
  • Attends and provides science support for investigator meetings and monitor workshops
  • Leads the safety review of clinical pharmacology studies and contribute to serious adverse event (SAE) reconciliation and SAE narratives
  • Primary scientific responsible for writing final study reports
  • Participates in the preparation of the IND and NDA documentation, the dossiers for formal regulatory meetings and materials for use in presentations and responses to regulatory authorities

Must Haves:

  • MSc, Pharm D or PhD in pharmaceutical sciences, clinical pharmacology sciences (Post Doc considered).
  • +2 years of experience in industry setting (preferably Pharma) supporting clinical pharmacology studies, NCA data analysis, regulatory filings and medical writing.
  • Clinical research experience, preferably in the pharmaceutical industry, with knowledge of ICH GCP and the drug development process
  • Previous experience/working knowledge of various approaches to PK and PD data analysis: compartmental, curve-fitting, non-compartmental.
  • Experience on software: Phoenix WinNonlin (plus Microsoft & Google Suites)
  • Highly effective verbal and written communication/presentation skills in English
  • Knowledge of Spotfire is a plus.

The ideal candidate has a clinical pharmacology (or pharmaceutical sciences) education with a minimum of a Master level. We are looking for someone with strong experience with PK/PD data analysis and a strong understanding and experience of working within clinical research. Please note profiles with an academic or hospital background are considered as long as they match the required criteria.

If you are interested please apply or reach out directly to (see below)

Job Title: Clinical Pharmacology Scientist

Location: Basel, Switzerland

Job Type: Contract

Aerotek and Actalent Services, an Allegis Group company. Allegis Group AG, CH-4051 Basel, Switzerland. Registration No. CHE-101.865.121. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available our website.

To access our Online Privacy Notice, which explains what information we may collect, use, share, and store about you, and describes your rights and choices about this, please go to the website.

We are part of a global network of companies and as a result, the personal data you provide will be shared within Allegis Group and transferred and processed outside the UK, Switzerland and European Economic Area subject to the protections described in the Allegis Group Online Privacy Notice. We store personal data in the UK, EEA, Switzerland and the USA. If you would like to exercise your privacy rights, please visit the "Contacting Us" section of our Online Privacy Notice for details on how to contact us. To protect your privacy and security, we may take steps to verify your identity, such as a password and user ID if there is an account associated with your request, or identifying information such as your address or date of birth, before proceeding with your request. If you are resident in the UK, EEA or Switzerland, we will process any access request you make in accordance with our commitments under the UK Data Protection Act, EU-U.S. Privacy Shield or the Swiss-U.S. Privacy Shield.

Reference: 1593934572

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