Sr. Medical Director-Clinical Research - United States
• Medical oversight for ongoing clinical trials throughout conduct and support all medical and scientific aspects of clinical trial (s) and program level activities as assigned, including interpretation of results, clinical study reports and graphical displays.
• Ensure appropriate scientific rigor in the design, conduct, validity and interpretation of clinical trial to support regulatory applications or business/marketing objectives.
• Contribute to the strategic planning, authoring, and review of regulatory documents, scientific data disclosures, and commercial support documents.
• Conduct and have oversight over medical monitoring activities and co-lead interactions with the Data Safety Monitoring Committee.
• Provide medical expertise and support to externally facing groups/stakeholders, including the field medical team, medical information and the commercial organization.
• Contribute and be responsible to the development planning, authoring and review of manuscripts and other scientific data disclosures.
Key Activities & Responsibilities:
• Contribute to/lead the strategic planning and execution of clinical development plans
• Provide medical input during the development and execution of clinical trials including protocol development through the review and interpretation of trial results and finalization of the clinical study report
• Medical support and/or authoring of clinical and regulatory documents including NDA/MAA, DSUR, briefing documents, regulatory responses, investigator brochure; Participate in regulatory interactions
• Provide medical support to lifecycle management activities as directed by Development Lead
• Provide medical support cross-functional collaborations to integrate broad medical, scientific, and commercial input into the medical affairs strategy and development program
• Provide scientific/medical expertise and support to externally facing groups, including the field medical team, medical information, business development and the commercial organization
• Contribute to the strategic planning, authoring, and review of medical and commercial support documents and initiatives including manuscripts, abstracts, posters, FAQs, standard response letters and promotional material
• Serve as a medical interface to key opinion leaders (KOL), facilitating KOL advocacy development
• Provide oversight and coaching to more junior clinical research personnel
• Maintain close collaboration and cooperation with clinical operations on the implementation and execution of clinical studies.
• Identify significant issues that may impact overall project plans and initiate contingency plans as appropriate
• Other duties as assigned.
• Prior experience in Hepatology, Gastroenterology, or related field, preferred.
• Prior industry experience as a medical monitor contributing to the preparation of clinical protocols, study reports, IND, IB, NDA/CTD documents. Prior industry experience in interactions and support of Medical Affairs and Commercial groups and activities.