Executive Director, Product Development Team Leader, Clinical Research, Hematology - Lymphoma
MSD
Summary
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.
Job description
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
- 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
- Leading internal governance presentations to senior management and committees, communicating progress and key changes in product development strategy between stage gates
Scientific Knowledge Maintenance
- 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
- 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
- Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects
Education
M.D or M.D./Ph.D. Required
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
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
- 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
- Ability to function in a matrix environment
- Excellence in delivering clear, impactful communication verbally, in writing, and during presentations
- 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
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- Retirement Benefits
- Paid Holidays
- Vacation
- Compassionate Leave
- Sick Days
- Annual Bonus
- Long-Term Incentive
Company overview
MSD, known as Merck Sharp & Dohme outside the United States and Canada, is a global research-intensive biopharmaceutical company headquartered in Rahway, New Jersey. Founded in 1891, the company has established itself as one of the world's leading pharmaceutical corporations with a rich history spanning over 130 years. MSD operates as the international division of Merck & Co., Inc., focusing on the discovery, development, manufacturing, and marketing of innovative medicines, vaccines, biologic therapies, and animal health products. The company's extensive portfolio includes groundbreaking treatments in oncology, infectious diseases, cardiology, diabetes, and vaccines, with notable products such as Keytruda (pembrolizumab) for cancer immunotherapy, Gardasil for HPV prevention, and Januvia for diabetes management. MSD maintains a strong commitment to research and development, investing significantly in scientific innovation to address unmet medical needs worldwide. With approximately 75,000 employees globally, the company operates through four main segments: pharmaceuticals, animal health, healthcare services, and strategic alliances. MSD's mission centers on using leading-edge science to save and improve lives around the world, guided by the principle that medicine is for people, not profits.