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Clinical Pharmacology Scientist
View: 109
Update day: 01-04-2024
Location: Basel Basel-Stadt BS
Category: R & D IT - Software
Industry: Staffing Recruiting
Position: Associate
Job type: Contract
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Job content
Do you want to work in a big pharmaceutical company? Do you have at least 2 years experience in clinical pharmacology? You should then read the following lines!Our client, based in Basel, is looking for a passionate Clinical Pharmacology Scientist for a 2 years contract with possibility of extension.
General Information
- Start date: ASAP (01.06)
- Latest possible start date: 3 months’ notice period considered
- Workload: 100%
- Remote/Home Office: Office set up with possibility of some WfH
- 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
- 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.
- Effective team work and interpersonal skills (globally, internal and externally) including coaching and mentoring
- Highly effective verbal and written communication/presentation skills in English
- Shows creativity, critical thinking, initiative and conscientiousness
- Ability to process information, analyze data, and reach conclusions based on sound reasoning and the rationale based on the risk- benefit assessment and cost-effectiveness.
- Knowledge of Spotfire? is a plus.
Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered
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Deadline: 16-05-2024
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