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

Job Description

Our Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state‑of‑the‑art technology and applying rigorous scientific and ethical standards.

The Distinguished Scientist (Executive Director) and Product Development Team (PDT) lead, Oncology Global Clinical Development, has primary responsibility for the planning and directing clinical research activities involving new or marketed drugs in the Oncology Clinical Research group and in the field of GI cancers.

The Executive Director, PDT lead will 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. They will provide internal scientific leadership for cross‑functional areas supporting clinical trials and will interact externally with key opinion leaders.

• Evaluating pre‑clinical and translational work to generate early clinical development plans 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.
• Participating in internal and joint internal/external research project teams relevant to the development of new compounds, and in the further study of marketed compounds and supporting business development assessments of external opportunities.
• Providing support for other therapeutic areas regarding clinical issues related to oncology compounds.

• Managing Directors and/or Senior Directors responsible for Oncology Global Clinical Development projects.
• Supervising the activities of the entire Clinical Teams in the execution of clinical studies.
• Reporting and working collaboratively with the Associate Vice President to promote the development strategy of the company on the indication of interest.
• Working 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 assisting 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.

• Maintaining awareness of scientific developments within their area of expertise, in terms of new scientific findings and 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 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 competency and to stay current on research activities in their area of responsibility.

• Authoring detailed development documents, presentations, budgets, and position papers for internal and external audiences.
• Facilitating collaborations with external researchers worldwide.
• Travel on company business about twenty percent of the time to manage future or ongoing clinical research projects.

• M.D. or M.D./Ph.D.

• Must have experience in industry in the field of GI…