Director, Clinical Development, US

CK Group are working with a very well backed biotechnology company with a biological product for liver disease soon to be entering Phase III clinical studies. To support these they are hiring a Physician Director, Clinical Development, this will be a permanent position and can be remotely based, anywhere in the US.RESPONSIBILITIES:As Physician Director, Clinical Development you will contribute to the execution of the Phase III clinical development programme for the company s lead product. Key duties include clinical trial execution, medical monitoring, data analysis and reporting of results for regulatory submissions or scientific presentations and publications.Key duties will include:Playing an active role in planning, conduct and evaluation of ongoing clinical trials to ensure successful executionServing as Medical Monitor for assigned clinical trials, conducting ongoing review of emerging medical/safety data and working closely with external CRO partnersSupporting and managing the preparation of materials for trial-related clinical committees such as Data Monitoring Committees, Adjudication Committees, etc.Contribution to planning, authoring, and critical review of documents submitted to regulatory authorities and ethics committee/IRBs as required (e.g., Protocols, CSRs, Investigator s Brochure, DSURs, clinical briefing documents, components of BLA/MAA submissions)Contribution to the strategic planning, authoring, and critical review of scientific data disclosures (e.g., ..... full job details .....
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