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Clinical Pharmacology Scientist 5192
vor 2 Wochen
**Clinical Pharmacology Scientist (SRS)**
Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. We are currently looking for a Clinical Pharmacology Scientist for a 12 month contract (extension possible) to be based in Basel, Switzerland.
Main Responsibilities:
- Be responsible for scientific aspects of the clinical pharmacology study protocol development, (including: creation of protocol synopsis, consent form, eCRF and protocol amendments);
- Take leadership over the evaluation of clinical pharmacology data (pharmacokinetics, pharmacodynamics, safety), review of study data and review data outputs for scientific and medical validity and consistency;
- Act as primary scientific responsible for writing final study reports;
- Participate in the preparation of the clinical pharmacology component of project specific Investigators Brochures, provide scientific support for investigator meetings and monitor workshops, lead the safety review of clinical pharmacology studies and contribute to serious adverse event related activities;
- Take part in preparing the IND and NDA documentation and other documents for formal regulatory meetings.
Qualifications and Experience:
- Relevant Swiss working/residency permit or Swiss/EU-Citizenship required;
- MSc, PharmD or PhD in pharmaceutical sciences or clinical pharmacology sciences;
- Industry experience in Pharmaceuticals and in Clinical Research with knowledge of ICH GCP and the drug development process;
- Previous experience of various approaches to PK and PD data analysis (compartmental, curve-fitting, non-compartmental)
- Good knowledge of PhoenixⓇ and/or WinNonlinⓇ (and Microsoft & Google Suites).
