Principal Scientist, Clinical Research, Thoracic Oncology

Clinical Director (Principal Scientist) — Oncology
• Plan and oversee execution of clinical research activities for new or marketed Oncology medicines across the clinical development lifecycle (pre-clinical to post-licensure), including study design, placement, monitoring, analysis, regulatory reporting, and publication.
• Evaluate pre-clinical and translational work to generate early clinical development plans and Investigational New Drug (IND) applications.
• Develop clinical development strategies for investigational or marketed Oncology drugs.
• Plan clinical trials (design, operational plans, settings) based on those strategies.
• Monitor and manage ongoing or new clinical trials.
• Analyze and summarize clinical findings to support safety/efficacy decisions and outputs such as new drug applications, clinical study reports, and publications.
• Participate in internal and joint internal/external research project teams relevant to development of new compounds and further study of marketed compounds.
• Oversee clinical study execution with Clinical Scientists in daily medical monitoring.
• Lead cross-functional collaboration with commercialization, regulatory affairs, statistics, and manufacturing.
• Inform senior leadership about competitor study progress and external/internal expert scientific input.
• Maintain scientific knowledge by tracking developments, identifying and engaging strong investigators, establishing communications with clinical investigators, and attending scientific meetings.
Education
• M.D. or M.D./Ph.D.
Required
• Experience in industry or academia
• Demonstrated 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
Preferred
• Board Certified or Eligible in Oncology (and/or Hematology)
• Prior clinical research experience and prior publication (desirable)
Required Skills
• Cancer Research, Clinical Development, Clinical Research, Clinical Studies, Clinical Trials, Medical Monitoring, Oncology