32 days ago on roche.com

Clinical Pharmacology Scientist

Roche AG

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Clinical Pharmacology Scientist

Clinical Pharmacology Scientist

Switzerland, Basel-Town, Basel

The Clinical Pharmacologist Scientist (CP), the CPSc is responsible for overall planning, management, data evaluation and reporting of clinical pharmacology studies. The CPSc leads protocol development and participates in study management as the primary clinical pharmacology representative. He/she provides clinical scientific input for final study reports and annual report documentation, and assists the CP in high-level IND and NDA documentation process. Alternatively, a CPSc position could be held by an individual who provides expertise in an area of critical importance to the Department, such as advanced data analysis techniques (e.g. population analysis) or data working environment (e.g. PKS).
The Clinical Pharmacologist Scientist will be responsible for the scientific aspects of clinical pharmacology study protocol development, including protocol synopsis, consent form, CRF and protocol amendments. They will also lead the evaluation of clinical pharmacology data (pharmacokinetics, pharmacodynamics, safety), interacting as required with operational staff and investigators, Data Management, Biostatistics and other partners.
  • Reviews data listings for scientific and medical validity and leads the ongoing review of study data e.g., PK, PD and safety
  • Conducts pre-study/initiation visits to investigative sites and 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 conducts serious adverse event (SAE) reconciliation and prepares SAE narratives
  • Primary responsible for writing final study reports and participates in the preparation of the IND and NDA documentation, the dossiers for formal regulatory meetings (e.g. EOP2) and materials for use in presentations and responses to regulatory authorities
  • Who you are
    You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
    A PhD, PharmD, MD or equivalent in a scientific qualification in pharmacology or related discipline with relevant related experience preferably in a pharmaceutical industry setting is required.
    • Working knowledge of various approaches to PK and PD data analysis: compartmental, curve-fitting, non-compartmental
    • Proficiency in the population data analysis a plus and knowledge of the appropriate computer software experience e.g., MS Word, Excel, PowerPoint, WinNonlin, Splus, Spotfire and NONMEM is preferred
    • Clinical research experience, preferably in the pharmaceutical industry, with an overall knowledge of ICH GCP and the drug development process
    • Experience of working on, and preferably leading a team matrixed around the scientific and/or clinical study-related tasks
    • Highly effective verbal and written communication/presentation skills in English are required
  • Who we are
    Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites. Read more.

    Roche is an equal opportunity employer.
  • Job facts
    • Location Switzerland, Basel-Town, Basel
    • Function Research
    • Subfunction Pharmacology
    • Schedule Full-time
    • Job level Individual Contributor
    • Job type Regular Employee
    • Division Roche Pharmaceuticals
    • Posted since 2017/11/15
    • Job-ID 3427611231
  • Get in touch
    Sabine Wehren +41 61 688 84 62