Executive Director, Product Development Team Leader, Clinical Research, Hematology - Lymphoma
Job DescriptionThe Executive Director (Distinguished Scientist) and Product Development Team (PDT) lead has primary responsibility for the planning and directing of clinical research activities involving new or marketed medicines in the Oncology therapeutic area, Hematology section.The Executive Director will manage and oversee the entire cycle of late-stage clinical development from Phase 2 to Phase 5, including development of program strategy and design, protocol authoring, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meetings. They will lead cross-functional product development teams that oversee program strategy and execution, will provide internal scientific leadership for cross-functional areas supporting clinical trials, and will interact externally with key scientific leaders.The Executive Director may be responsible for:Evaluating pre-clinical and translational work for the purpose of generating early clinical development plans and Investigational New Drug (IND) applicationsDeveloping clinical development strategies for investigational or marketed medicines that incorporate the latest scientific developments, regulatory requirements, the competitive landscape, and commercial considerationsExecuting the clinical strategy, planning clinical trials (design, operational plans, settings), and leading the clinical subteamMonitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed medicinesLeading cross-functional product development teams that oversee overall strategy and execution for investigational or marketed medicinesActing as an integration of cross-functional input and expertise, ensuring all perspectives are incorporated into the strategy/plan and serve as the product development team spokespersonAnalyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publicationsParticipating in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compoundsSupporting business development assessments of external opportunities.Managing Clinical Directors and/or Senior Clinical Directors responsible for [insert therapeutic area] clinical development work, demonstrating effective leadership and fostering a high-performance cultureWorking closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects, and assist the Associate Vice President and/or Vice President in ensuring that appropriate Corporate personnel are informed of the progress of studies of our company and competitors' drugs, and of internal and external expert opinion on scientific questions relevant to their areas of responsibilityLeading internal governance presentations...