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

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

• Evaluating pre-clinical and translational work for the purpose of generating early clinical development plans and Investigational New Drug (IND) applications
• Developing clinical development strategies for investigational or marketed medicines that incorporate the latest scientific developments, regulatory requirements, the competitive landscape, and commercial considerations
• Executing the clinical strategy, planning clinical trials (design, operational plans, settings), and leading the clinical subteam
• Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed medicines
• Leading cross-functional product development teams that oversee overall strategy and execution for investigational or marketed medicines
• Acting 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
• Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publications
• Supporting 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 culture
• Working 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
• Leading 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

Qualifications

• M.D. or M.D./Ph.D. required
• 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
• Prior specific experience in clinical research and prior publication record
• Product registration experience desirable

Skills

• Excellent interpersonal and collaborative skills, as well as the ability to function in a matrix environment
• Outstanding communication skills, both verbal and written
• Strategic leadership and decision-making abilities
• Ability to manage cross-functional teams and projects
• Strong scientific consulting and clinical judgment skills

Benefits

The salary range for this role is $310,900.00 - $489,400.00. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits, including medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.