Archiviertes Projekt - Clinical Pharmacology Scientist (m/f/d)

Ihre Aufgaben:
• Responsible for the scientific aspects of clinical pharmacology study protocol development, including protocol synopsis, consent form, eCRF and protocol amendments
• Lead the evaluation of clinical pharmacology data (pharmacokinetics, pharmacodynamics, safety), interacting as required with operational staff and investigators, Data Management, Biostatistics and other partners
• Lead the ongoing review of study data (e.g. PK, PD and safety) and review data outputs for scientific and medical validity and consistency
• Assist in the preparation of the clinical pharmacology component of the project specific Investigators Brochure
• Attend and provide science support for investigator meetings and monitor workshops
• Lead 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
• Participate 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

Ihre Qualifikationen:
• MSc, Pharm D or PhD in pharmaceutical sciences, clinical pharmacology sciences (Post Doc considered)
• 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 (Microsoft and 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 EnglishShows 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

Ihre Vorteile:
• A very renowned company
• You will work in an international environment

Projektdauer: 24 MM++


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