Distinguished Scientist, Product Development Team Leader, Clinical Research - GI oncology

About the role

The Distinguished Scientist (Executive Director) and Product Development Team (PDT) lead, Oncology Global Clinical Development, manages clinical research activities involving new or marketed drugs in the Oncology Clinical Research group and in the field of GI cancers. They oversee 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.

Responsibilities

• 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.
• Supervise the activities of entire Clinical Teams in the execution of clinical studies.
• Report and work collaboratively with the Associate Vice President to promote the development strategy of the company on the indication of interest.
• Work closely with a cross-functional Senior/Executive Director group of experts in commercialization, regulatory affairs, statistics, medical affairs and manufacturing to manage clinical development projects; and assist the Associate Vice President 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.

Qualifications

• M.D. or M.D./Ph.D. Required
• 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, as well as the ability to function in a team environment, are essential

Preferred Qualifications

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