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Executive Director, Product Development Team Leader, Clinical Research, Hematology - Lymphoma
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#31819
Remote / WFH
Merck
Job Description
Job Description
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.
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
Education:
M.D or M.D./Ph.D.
Required Experience and Skills:
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
Preferred Experience and Skills:
Board Certified or Eligible in Oncology, Hematology, or related discipline
Lymphoma experience
Prior specific experience in clinical research and prior publication record
Product registration experience desirable
Required Skills:
Clinical Investigations, Clinical Judgment, Clinical Research, Clinical Trial Planning, Consultative Approach, Cross-Cultural Awareness, Drug Development, Ethical Standards, Innovation, New Technology Integration, Professional Networking, Regulatory Requirements, Results-Oriented, Scientific Consulting, Strategic Leadership
The salary range for this role is
$310,900.00 - $489,400.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. 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.
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.
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
Education:
M.D or M.D./Ph.D.
Required Experience and Skills:
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
Preferred Experience and Skills:
Board Certified or Eligible in Oncology, Hematology, or related discipline
Lymphoma experience
Prior specific experience in clinical research and prior publication record
Product registration experience desirable
Required Skills:
Clinical Investigations, Clinical Judgment, Clinical Research, Clinical Trial Planning, Consultative Approach, Cross-Cultural Awareness, Drug Development, Ethical Standards, Innovation, New Technology Integration, Professional Networking, Regulatory Requirements, Results-Oriented, Scientific Consulting, Strategic Leadership
The salary range for this role is
$310,900.00 - $489,400.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. 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.
