Clinical Pharmacology Scientist

vor 3 Wochen


Basel, Schweiz Coopers Group AG Vollzeit

**Clinical Pharmacology Scientist**

For our client in Basel we are looking for a person responsible for planning, management, data evaluation and reporting of clinical pharmacology studies. You will lead protocol development and participate in study management as the primary clinical pharmacology representative.

**Responsibilities**:

- Responsible for the scientific aspects of clinical pharmacology study protocol development, including protocol synopsis, consent form, eCRF and protocol amendments
- Leads 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 (e.g. PK, PD and safety) and reviews data outputs 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 (e.g. EOP1, EOP2) and materials for use in presentations and responses to regulatory authorities

**Your profile**:

- 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)
- Experience of working on, and preferably leading a team matrixed around the scientific and/or clinical study-related tasks

Sounds like a great job?



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