Distinguished Scientist, Clinical Research, Thoracic Malignancies

Merck•Boston, MA

1d•Hybrid

About The Position

The Clinical Development teams manage studies to provide safety and efficacy data for regulatory approval of new drugs and indications. The Distinguished Scientist (Executive Director) and Product Development Team (PDT) Lead, Oncology Global Clinical Development, is primarily responsible for planning and directing clinical research activities for new or marketed drugs in Thoracic Oncology. This role involves managing the entire clinical development cycle, including strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at meetings. The Executive Director will provide internal scientific leadership, interact with key opinion leaders, and may manage Directors and Senior Directors within Oncology Global Clinical Development projects. They will supervise Clinical Teams, report to the Section Head, and collaborate with cross-functional experts in commercialization, regulatory affairs, statistics, medical affairs, and manufacturing. Responsibilities also include maintaining a strong scientific knowledge base by staying aware of scientific developments, identifying strong investigators, establishing communications with prominent clinical investigators, and attending scientific meetings. The role may involve authoring development documents, presentations, budgets, and position papers, as well as facilitating collaborations with external researchers.

Requirements

M.D or M.D./Ph.D.
Experience in industry in the field of Thoracic Oncology
Minimum of 3 years of clinical medicine experience
Minimum of 5 years of industry experience in drug development
Demonstrated record of scientific scholarship and achievement
A proven track record in clinical medicine and background in biomedical research is essential
Strong interpersonal skills
Ability to function in a team environment
Clinical Development
Clinical Judgment
Clinical Medicine
Clinical Research
Clinical Trial Planning
Clinical Trials
Cross-Cultural Awareness
Cross-Functional Teamwork
Drug Development
Ethical Standards
Medical Research
Oncology
Pulmonology
Regulatory Requirements
Research Methodologies
Scientific Consulting
Scientific Leadership
Scientific Research
Strategic Leadership

Nice To Haves

Board Certified or Eligible in Oncology (and/or Hematology)
Prior specific experience in clinical research and prior publication

Responsibilities

Planning and directing clinical research activities involving new or marketed drugs in the Oncology Clinical Research group and in the field of Thoracic Oncology
Managing the entire cycle of clinical development, including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meeting
Providing internal scientific leadership for cross-functional areas supporting clinical trials
Interacting externally with key opinion leaders
Evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications
Developing clinical development strategies for investigational or marketed agents that incorporate the latest scientific developments, regulatory requirements, the competitive landscape, and commercial considerations
Planning clinical trials (design, operational plans, settings) based on these clinical development strategies
Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed agents
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
Participation in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds and support of business development assessments of external opportunities
Provide support for other therapeutic areas regarding clinical issues related to oncology compounds
Manage Directors and/or Senior Directors responsible for Oncology Global Clinical Development projects (may)
Supervise the activities of entire Clinical Teams in the execution of clinical studies (may)
Report to and work collaboratively with the Section Head to promote the development strategy of the company on the indication of interest
Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, medical affairs and manufacturing to manage clinical development projects
Assist the Section Head in ensuring that appropriate Corporate personnel is informed of the progress of studies of our company and competitors' drugs and internal and external expert opinion on scientific questions relevant to their areas of responsibility
Maintaining awareness of scientific developments within their area of expertise, in terms of new scientific findings, research methodologies
Identification of 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 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 detailed development documents, presentations, budgets, and position papers for internal and external audiences (may)
Facilitating collaborations with external researchers around the world (may)
Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects