Distinguished Scientist, Clinical Research, Thoracic Malignancies

MSD•Boston, MA

23h•Hybrid

About The Position

The Clinical Development teams are responsible for managing 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, holds primary responsibility for planning and directing clinical research activities for new or marketed drugs within the Oncology Clinical Research group, specifically focusing on Thoracic Oncology. This role encompasses the entire clinical development cycle, including strategy development, study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meetings. The Executive Director will provide internal scientific leadership for cross-functional areas supporting clinical trials and will engage externally with key opinion leaders. They may also manage Directors and/or Senior Directors responsible for Oncology Global Clinical Development projects and supervise Clinical Teams. The position requires collaborative work with the Section Head and a cross-functional group of experts in commercialization, regulatory affairs, statistics, medical affairs, and manufacturing. Maintaining a strong scientific knowledge base, identifying strong investigators, establishing communications with prominent clinical investigators, and attending scientific meetings are also key aspects of the role. Travel of approximately 20% for company business is expected.

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.

Nice To Haves

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

Responsibilities

Plan and direct clinical research activities involving new or marketed drugs in the Oncology Clinical Research group and in the field of Thoracic Oncology.
Manage the entire cycle of clinical development, including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meetings.
Provide internal scientific leadership for cross-functional areas supporting clinical trials.
Interact externally with key opinion leaders.
Evaluate pre-clinical and translational work for the purpose of generating early clinical development plans and Investigational New Drug applications.
Develop clinical development strategies for investigational or marketed agents that incorporate the latest scientific developments, regulatory requirements, the competitive landscape, and commercial considerations.
Plan clinical trials (design, operational plans, settings) based on clinical development strategies.
Monitor and manage the conduct of ongoing or new clinical trials for investigational or marketed agents.
Analyze and summarize the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publications.
Participate 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.
Maintain awareness of scientific developments within their area of expertise, in terms of new scientific findings, research methodologies.
Identify scientifically and operationally strong investigators who can assist in the development of our company's investigational and marketed drugs.
Establish communications with prominent clinical investigators in their field of interest.
Attend appropriate scientific meetings to maintain 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).
Facilitate 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 (may).