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

Merck•North Wales, PA

11d•Hybrid

About The Position

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. Specifically, 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) 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 Participating in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds 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 The Executive Director is responsible for maintaining a strong scientific fund of knowledge by: Maintaining awareness of scientific developments within their area of expertise, in terms of new scientific findings, research methodologies Identifying scientifically and operationally strong 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 Attending appropriate scientific meetings to maintain their competency and to maintain awareness of research activities in their area of responsibility. To accomplish these goals, the Executive Director may: Author and/or oversee detailed development documents, presentations, budgets, and position papers for internal and external audiences Facilitate collaborations with external researchers around the world Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects.

Requirements

M.D or M.D./Ph.D.
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
Proven track record in clinical medicine and background in biomedical research
Outstanding interpersonal and collaborative skills, as well as the ability to function in a matrix environment
Excellence in delivering clear, impactful communication verbally, in writing, and during presentations
Clinical Development
Clinical Investigations
Clinical Reporting
Clinical Research
Clinical Trial Planning
Clinical Trials
Cross-Functional Collaboration
Drug Development
Ethical Standards
Hematology
Innovation
Regulatory Affairs Compliance
Regulatory Requirements
Results-Oriented
Scientific Consulting
Strategic Leadership

Nice To Haves

Board Certified or Eligible in Oncology, Hematology, or related discipline
Myeloproliferative Disorders experience
Prior specific experience in clinical research and prior publication record
Product registration experience desirable

Responsibilities

Planning and directing of clinical research activities involving new or marketed medicines in the Oncology therapeutic area, Hematology section.
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.
Lead cross-functional product development teams that oversee program strategy and execution.
Provide internal scientific leadership for cross-functional areas supporting clinical trials.
Interact externally with key scientific leaders.
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.
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.
Participating in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds.
Supporting business development assessments of external opportunities.
Managing Clinical Directors and/or Senior Clinical Directors responsible for 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.
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.
Maintaining awareness of scientific developments within their area of expertise, in terms of new scientific findings, research methodologies.
Identifying scientifically and operationally strong 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.
Attending appropriate scientific meetings to maintain their competency and to maintain awareness of research activities in their area of responsibility.
Author and/or oversee detailed development documents, presentations, budgets, and position papers for internal and external audiences.
Facilitate collaborations with external researchers around the world.

Benefits

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days

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