Distinguished Scientist, Clinical Research, Thoracic Malignancies

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.

• Evaluate pre‑clinical and translational work to generate early clinical development plans and Investigational New Drug applications.
• Develop clinical development strategies for investigational or marketed agents that incorporate scientific advances, regulatory requirements, commercial considerations, and competition.
• 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 the clinical findings from studies to support decisions regarding safety and efficacy, and to support 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, the further study of marketed compounds, and support 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 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 the area of expertise, identify scientifically and operationally strong investigators who can assist in the development of our company’s investigational and marketed drugs, and establish communications with prominent clinical investigators in the field of interest. Attend appropriate scientific meetings to maintain competency and awareness of research activities in the area of responsibility.
• 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.

• Education:
  
  M.D. or M.D./Ph.D.
• Minimum 3 years of clinical medicine experience.
• Minimum 5 years of industry experience in drug development.
• Experience in industry in the field of Thoracic Oncology.
• Demonstrated record of scientific scholarship and achievement.
• Strong interpersonal skills and ability to function in a team environment.
• Board Certified or Eligible in Oncology (and/or Hematology).
• Prior specific experience in clinical research and prior publication.

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

Not applicable.

As an Equal Employment Opportunity Employer, we 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.

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Salary range: $ – $. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. Benefits include medical, dental, vision, retirement benefits, paid holidays, vacation and compassionate and sick days.