Senior Principal Scientist (Senior Director), Clinical Research, Breast Cancer
About The Position
The Senior Director (Sr. Principal Scientist) leads clinical research activities for new or marketed oncology medicines across all phases of clinical development, from pre-clinical work through post-licensure. The role manages the clinical development cycle, including study design and placement, monitoring, analysis, regulatory reporting, and publication. The position develops clinical strategies and plans, oversees clinical trials, and interprets findings to inform safety and efficacy decisions, regulatory submissions, clinical study reports, and publications. It may supervise Clinical Scientists and works closely with experts in commercialization, regulatory affairs, statistics, and manufacturing, as well as internal and external research teams and investigators. The role maintains expertise in relevant scientific developments and research methods, identifies and engages qualified clinical investigators, attends scientific meetings, and prepares development documents, presentations, budgets, and position papers. It may facilitate collaborations with external researchers and requires business travel. The position is based in Rahway, New Jersey, with a hybrid work arrangement and an expected travel requirement listed as 25%.
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 and prior publication.
Responsibilities
- Evaluate pre-clinical and translational work to develop 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 and 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 focused on new compounds and further study of marketed compounds.
- Supervise Clinical Scientists in the execution of clinical studies, as needed.
- Collaborate with cross-functional experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects.
- Assist the Senior/Executive Director in keeping corporate personnel informed about study progress, competitor drugs, and relevant internal and external expert opinions.
- Maintain awareness of scientific developments, new findings, and research methodologies in the area of expertise.
- Identify scientifically and operationally strong investigators and establish communications with prominent clinical investigators.
- Attend 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.
Benefits
- Medical, dental, and vision healthcare benefits 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.
- Domestic relocation.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
