Senior Principal Scientist (Senior Director), Clinical Research, Breast Cancer

Responsibilities

• Evaluate pre-clinical and translational work for generating early clinical development plans and Investigational New Drug applications.
• Develop clinical development strategies for investigational or marketed Oncology drugs.
• Plan clinical trials, including design, operational plans, and settings, based on clinical development strategies.
• Monitor and manage the conduct of ongoing or new clinical trials for investigational or marketed Oncology drugs.
• Analyze and summarize clinical findings from studies to support decisions regarding safety and efficacy, new drug applications, clinical study reports, or publication.
• Participate in internal and joint internal/external research project teams relevant to the development of new compounds and the further study of marketed compounds.
• Supervise the activities of Clinical Scientists in the execution of clinical studies.
• Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects.
• Assist the Senior/Executive Director in ensuring that appropriate corporate personnel are informed of the progress of studies of our company's and competitors' drugs and internal and external expert opinion on scientific questions relevant to areas of responsibility.
• Maintain awareness of scientific developments within the area of expertise, in terms of new scientific findings and research methodologies.
• Identify scientifically and operationally strong investigators who can assist in the development of our company's investigational and marketed drugs.
• Establish communications with prominent clinical investigators in the field of interest.
• Attend appropriate scientific meetings to maintain competency and awareness of research activities.
• Author detailed development documents, presentations, budgets, and position papers for internal and external audiences.
• Facilitate collaborations with external researchers around the world.
• Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects.

Qualifications

• M.D or M.D./Ph.D.
• Experience in industry or senior faculty in academia.
• Minimum of 3 years of clinical medicine experience.
• Minimum of 3 year of industry experience in drug development or biomedical research experience in academia.
• Demonstrated record of scientific scholarship and achievement.
• Proven track record in clinical medicine and background in biomedical research.
• Strong interpersonal skills and ability to function in a team environment.

Preferred Qualifications

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