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 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.

• Evaluate pre‑clinical and translational work to generate early clinical development plan and Investigational New Drug applications.
• Develop clinical development strategies for investigational or marketed agents incorporating latest scientific developments, regulatory requirements, competitive landscape, and commercial considerations.
• Plan clinical trials (design, operational plans, settings) based on these strategies.
• Monitor and manage the conduct of ongoing or new clinical trials for investigational or marketed agents.
• Analyze and summarize clinical findings from studies to support decisions regarding safety and efficacy, new drug applications, clinical study reports, or publications.
• Participate in internal and joint internal/external research project teams relevant to development of new compounds and further study of marketed compounds, supporting 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 activities of entire Clinical Teams in study execution.
• Report and work collaboratively with the Associate Vice President to promote the company’s development strategy on the indication of interest.
• Work closely with a cross‑functional Senior/Executive Director group of experts to manage clinical development projects and assist the Associate Vice President in ensuring appropriate corporate personnel are informed of study progress.
• Maintain a strong scientific body of knowledge by staying aware of scientific developments, identifying strong investigators, establishing communications with prominent clinical investigators, and attending scientific meetings.
• Author detailed development documents, presentations, budgets, and position papers for internal and external audiences.
• Facilitate 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. with specialty in GI cancers.
• 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.
• Proven track record in clinical medicine and background in biomedical research.
• Strong interpersonal skills and ability to work in a team environment.

• Board Certified or Eligible in Oncology (and/or Hematology).
• Prior specific experience in clinical research and prior publication record.
• Experience in oncology trials and gastrointestinal cancer.
• Experience in leading project teams, strategic leadership, and cross‑functional teamwork.

• Competitive salary range of $ to $, with eligibility for annual bonus and long‑term incentive.
• Comprehensive benefits package including medical, dental, vision, other insurance benefits for employee and family, retirement benefits (401(k)), paid holidays, vacation, compassionate and sick days.

We are an Equal Employment Opportunity Employer and provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

The salary range for this role is $ - $. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable.