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Clinical Scientist
6 month contract, part-time 50% (extension possible)
You will participate in the development of the early clinical development strategy and plans and support the medical lead with various deliverables necessary for effective and efficient execution of the clinical development plan for the assigned molecules or indications.
Responsibilities:
- Provide operational and scientific leadership expertise in all aspect of study planning, evaluation and documentation for a number of assigned global Phases I-II studies within the agreed strategy, budget and timelines
- Lead the clinical protocol development process by engaging line function input at the appropriate time
- Retain operational and scientific input into the finalization of clinical development plans and study related documents, including but not limited to protocols, reports, investigator brochures, IND annual reports, Health Authority (HA) briefing books, IND submissions and responses to Health Authoritys (HA) questions
- Lead the clinical trial data and medical-scientific review, final analysis and interpretation including the development of clinical trial reports, publications and internal/ external presentations, jointly with the medical lead
- Provide direction to the global multidisciplinary, cross-functional Study Management Team (SMT) to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedure, within a matrix environment
Requirments:
- Minimum PhD in Life sciences or MD
- 5-10 years of experience with strong expertise in Drug development and clinical studies
- Experience in running and setting up clinical trials
- Strong GCP knowledge
- Scientific expertise documented by publications, ideally has experience writing clinical study protocols
Sounds like a great job?
Then we look forward to receiving your complete application documents through our online application form.
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