Senior Principal Scientist (Senior Director), Clinical Research, Breast Cancer
About The Position
The Senior Director (Senior Principal Scientist) has primary responsibility for planning and directing clinical research activities involving new or marketed oncology medicines. Oncology medicines span all phases of clinical development, from pre-clinical research through post-licensure. The role manages the clinical development cycle, including study design, placement, monitoring, analysis, regulatory reporting, and publication. The role evaluates pre-clinical and translational work to develop early clinical plans and Investigational New Drug applications, develops clinical strategies, plans and manages trials, and analyzes and summarizes clinical findings to inform safety and efficacy decisions, applications, study reports, and publications. It also participates in internal and joint research teams and may supervise Clinical Scientists. The Senior Director works with experts across commercialization, regulatory affairs, statistics, and manufacturing, and may assist senior leadership in keeping relevant corporate personnel informed about study progress, competitor medicines, and scientific opinions. The role maintains scientific expertise, identifies and builds relationships with investigators, attends scientific meetings, prepares development documents and other materials, and facilitates collaborations with external researchers worldwide. Travel is required for managing clinical research projects; the posting lists travel requirements of 25% and describes travel as about 20% of the time.
Requirements
- M.D. or M.D./Ph.D.
- Experience in industry or as senior faculty in academia.
- At least 3 years of clinical medicine experience.
- At least 3 years 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 a background in biomedical research.
- Strong interpersonal skills and ability to function in a team environment.
- Skills in breast cancer research, clinical medicine, clinical research, clinical research management, clinical trial development, cross-functional teamwork, drug development, and oncology research.
Nice To Haves
- Board certified or eligible in Oncology and/or Hematology.
- Prior specific experience in clinical research.
- Prior publication.
Responsibilities
- 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 oncology drugs.
- Plan clinical trials, including their design, operational plans, and settings.
- Monitor and manage ongoing or new clinical trials for investigational or marketed oncology drugs.
- Analyze and summarize clinical findings to support safety and efficacy decisions, new drug applications, clinical study reports, and publications.
- Participate in internal and joint internal/external research project teams relevant to new compounds and further study of marketed compounds.
- Supervise Clinical Scientists in the execution of clinical studies, as applicable.
- Work with cross-functional experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects.
- Assist senior leadership in informing corporate personnel about study progress, competitor drugs, and relevant scientific questions.
- Maintain awareness of scientific developments, research methodologies, and activities in the area of responsibility.
- Identify strong scientific and operational investigators and establish communications with prominent clinical investigators.
- Attend scientific meetings to maintain competency and awareness of research activity.
- Author development documents, presentations, budgets, and position papers for internal and external audiences.
- Facilitate collaborations with external researchers around the world.
- Travel on company business to manage future or ongoing clinical research projects.
Benefits
- Medical, dental, and vision healthcare and other insurance benefits for employees and family.
- Retirement benefits, including 401(k).
- Paid holidays, vacation, compassionate days, and sick days.
- Eligible for annual bonus and long-term incentive, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
