* Will represent Clinical Development and lead Global Development and Program Teams
* Will Lead teams to drive transition of pre-Proof of Concept to Development Decision Point (DDP) and Post-DDP you will lead the development and execution of the clinical strategy. You will develop an endorses Integrated Development Plan in line with Target Product Profile which is designed for successful global regulatory approval and market access for multiple treatment indications.
* Leads the creation of key clinical documents: Clinical Trial Protocols (CTPs), Investigator's Brochures, Clinical Study Reports (CSRs), regulatory documents including maintenance of product licenses, registration dossiers, value dossiers, pharmacoeconomic dossiers.
* Supports registration, market access, commercialization, and maintenance of product licenses.
* Together with Patient Safety, ensures continuous evaluation of drug safety profile, including safety monitoring of clinical studies and signal detection from post-marketing surveillance.
* As the medical expert, leads interactions with external stakeholders: regulatory authorities, data monitoring committees, advisory boards, patient advocacy groups; internal stakeholders: Research, Translational Medicine, Global Medical Affairs (GMA), Marketing, Health Economics & Outcomes Research)
* Plans and executes publication and clinical communication strategy in coordination with GMA and Medical Writing, and provides input into key external presentations
* Leads or serves as Subject Matter Expert for Clinical Development line function initiatives.
* Medical Doctor; Medical Board certification preferred for MD
* Board registered Psychiatrist - This is a must have.
· ≥6 years of involvement in clinical research or drug development in an industry environment spanning clinical activities in Phases I through III/IV, including submission dossiers
· Advanced knowledge of assigned therapeutic area required with capability to innovate in clinical development study designs
· Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory/clinical development process
· Experience with submissions and health authorities required
· Demonstrated ability to establish strong scientific partnership with key stakeholders
· Demonstrated leadership and management skills with a documented track record of delivering high quality projects, submissions, trials in a global and matrix environment (including remote) in pharmaceutical or biotech industry
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