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Sr Director Clinical Development
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Full-time
- Strategic responsibilities include scientific support design and execution of clinical development plans for the respective therapeutic or disease area through all stages of development The incumbent will be responsible for leading clinical trials, developing and authoring the necessary documents (e.g. NDA/CTA submissions, study protocols, Investigator Brochures, regulatory briefing books and regulatory response documents, clinical study reports, etc.)
- Directing the integration of the Clinical Development Plan (CDP) and the Drug Development Plan
- Leading the development of Clinical Protocols to meet CDP objectives
- Serving as Study Director and driving the execution of the study from protocol concept to final report including interpretation of clinical data
- Minimum of 5 years' experience in clinical development in immunology or neuroscience clinical research with solid knowledge and experience of overall and early clinical development in respective therapeutic area and involvement in clinical trial design or execution.
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