Senior Principal Scientist (Senior Director), Clinical Research, Breast Cancer
About The Position
The Senior Principal Scientist, Breast Cancer, is part of the research and development division and leads clinical research and drug development activities in oncology. The role evaluates pre-clinical and translational work to develop early clinical development plans and Investigational New Drug applications, and develops strategies and plans for clinical trials of investigational or marketed oncology drugs. It oversees study conduct, analyzes and summarizes clinical findings to inform safety and efficacy decisions and regulatory submissions, and contributes to study reports and publications. The position participates in research project teams, supervises Clinical Scientists, and collaborates with experts in commercialization, regulatory affairs, statistics, and manufacturing. It also monitors scientific developments, identifies and communicates with clinical investigators, attends scientific meetings, authors development materials, and facilitates collaborations with external researchers worldwide. The posting specifies business travel of about 20 percent in the role responsibilities and 25 percent in the travel requirements section. The position is hybrid, based primarily in Rahway, New Jersey, with domestic relocation listed.
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.
- Breast cancer, clinical development, clinical judgment, clinical research, clinical trials, drug development, and oncology research skills.
Nice To Haves
- Board certified or board eligible in Oncology and/or Hematology.
- Prior specific experience in breast cancer 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, based on clinical development strategies.
- Monitor and manage ongoing or new clinical trials for investigational or marketed oncology drugs.
- Analyze and summarize clinical study 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 concerning new compounds and further study of marketed compounds.
- Supervise Clinical Scientists in executing clinical studies.
- Work with cross-functional experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects.
- Assist the Senior/Executive Director in informing appropriate corporate personnel about study progress, competitor drugs, and internal and external expert opinion on relevant scientific questions.
- Maintain awareness of scientific developments, findings, and research methodologies in the area of expertise.
- Identify scientifically and operationally strong investigators to assist in developing investigational and marketed drugs.
- Establish communications with prominent clinical investigators in the field.
- Attend appropriate scientific meetings to maintain competency and awareness of research activities.
- 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; the responsibilities section says about 20 percent, while the travel requirements section says 25 percent.
Benefits
- Medical, dental, vision healthcare, and other insurance benefits for employees and families.
- Retirement benefits, including 401(k).
- Paid holidays, vacation, compassionate days, and sick days.
- 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
