Executive Director, Product Development Team Leader, Clinical Research, Hematology

About the role

The 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.

Responsibilities

• Evaluate pre-clinical and translational work for the purpose of generating early clinical development plans and Investigational New Drug (IND) applications
• Develop clinical development strategies for investigational or marketed medicines that incorporate the latest scientific developments, regulatory requirements, the competitive landscape, and commercial considerations
• Execute the clinical strategy, planning clinical trials (design, operational plans, settings), and leading the clinical subteam
• Monitor and manage the conduct of ongoing or new clinical trials for investigational or marketed medicines
• Lead cross-functional product development teams that oversee overall strategy and execution for investigational or marketed medicines
• Act 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 spokesperson
• Analyze and summarize the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publications
• Participate in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds
• Support business development assessments of external opportunities
• Manage Clinical Directors and/or Senior Clinical Directors responsible for [insert therapeutic area] clinical development work, demonstrating effective leadership and fostering a high-performance culture
• Work 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 responsibility
• Lead internal governance presentations to senior management and committees, communicating progress and key changes in product development strategy between stage gates, ensuring early alignment with line management, and facilitating issue escalation and cross-functional collaboration as needed for governance approval

Requirements

• Minimum of 3 years of clinical medicine experience
• Minimum of 5 years of industry experience in drug development with demonstrated success in overseeing multiple studies and protocols through completion
• Experience in authoring regulatory documents and leading discussions with regulatory agencies
• Demonstrated record of scientific scholarship and achievement
• Prioritizing scientific and operational strength in investigators who can assist in the development of our company's investigational and marketed drugs
• Establishing communications with prominent clinical investigators in their particular field of interest, particularly those who will be willing and able to assist in the evaluation of our company's drugs
• Maintaining awareness of scientific developments within their area of expertise, in terms of new scientific findings, research methodologies
• Attending appropriate scientific meetings to maintain their competency and to maintain awareness of research activities in their area of responsibility

Skills

• Current Board Certification or Eligibility in Oncology, Hematology, or related discipline
• Experience in Myeloproliferative Disorders
• Product registration experience desirable
• Excellent interpersonal and collaborative skills, as well as the ability to function in a matrix environment
• Outstanding communication skills, both verbal and written
• Results-oriented and strategic leadership