Description: Mission Statement:
This position will be focused on the evaluation of drug candidates for entry to clinical study and the development of the most suitable plan for early stage clinical trials. You will work closely with a multi- functional core project team (that includes representatives from research, marketing, manufacturing, toxicology & regulatory) to define critical clinical questions and prepare the proper documents to permit well-designed clinical trials. This is a unique and challenging opportunity to participate in all aspects of clinical development, from initial proof of concept to large licensing studies.
RESPONSIBILITIES:
*Primary author of clinical development plans for new development projects.
*Design relevant clinical trials including first-in-human up to pivotal trials to ensure consistency of data within program and across projects.
*Collaborate with research/translational medicine colleagues to address Research and Development questions.
*Prepare master study documents, including protocol, informed consent, analytical plan and clinical study reports.
*Prepare and update project related documents such as Investigator Brochure and be responsible for final Clinical Study Reports and publications.
*Coordinate budgets.
*Ensure supplies in collaboration wiTh Clinical Services.
*Provide medical support to scientific advisory boards.
*Conduct networking with thought leaders and international agencies as needed.
*You may also assist Business Development and Licensing with clinical assessments of new in- licensing opportunities.
*Provide medical support to Strategic Global Marketing.
