Principal Scientist (Director), Clinical Research, Atherosclerosis
About The Position
The Principal Scientist (Director) has primary responsibility for planning and directing clinical research involving new or marketed medicines in the Atherosclerosis section of the Atherosclerosis & Metabolism therapeutic area. The medicines span all phases of clinical development, from pre-clinical development to post-licensure. The role manages the full cycle of late-stage clinical development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. The Director may plan clinical trials based on clinical development strategies; manage ongoing or new trials for investigational or marketed medicines; analyze and summarize study findings to support safety and efficacy decisions, new drug applications, clinical study reports, and publications; and participate in internal and joint internal/external research project teams. The position also supports business development assessments of external opportunities. The Director collaborates with Clinical Scientists and cross-functional experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects. The role helps ensure relevant corporate personnel are informed about study progress, competitor medicines, and scientific opinions from internal and external experts. The position requires maintaining scientific expertise and awareness of developments and research methodologies, identifying strong investigators, building relationships with prominent clinical investigators, and attending relevant scientific meetings. The Director may author development documents, presentations, budgets, and position papers; facilitate collaborations with external researchers worldwide; and travel on company business. The posting lists travel requirements as 10%. The position is hybrid, based primarily in Rahway, New Jersey, with domestic relocation indicated.
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 1 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.
- Strong verbal and written communication and presentation skills.
- Required skills include cardiology, cardiovascular diseases, clinical development, clinical judgment, clinical research, and clinical trial planning.
Nice To Haves
- Board certified or board eligible in Cardiology (adult or pediatric), Endocrinology, Nephrology, or a related discipline.
- Prior specific experience in clinical research and prior publication.
Responsibilities
- 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 Atherosclerosis & Metabolism medicines.
- 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 for development of new compounds and further study of marketed compounds.
- Support business development assessments of external opportunities.
- Collaborate with Clinical Scientists in executing clinical studies.
- Work with cross-functional experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects.
- Help ensure corporate personnel are informed about study progress, competitor medicines, and internal and external scientific opinions relevant to areas of responsibility.
- Maintain awareness of scientific developments and research methodologies in the area of expertise.
- Identify scientifically and operationally strong investigators and establish communications with prominent clinical investigators.
- 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.
Benefits
- Medical, dental, vision healthcare, and other insurance benefits for employees and family.
- Retirement benefits, including 401(k).
- Paid holidays.
- Vacation.
- Compassionate 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
Director
Education Level
Ph.D. or professional degree
