Principal Scientist, Clinical Research
About The Position
The Principal Scientist (identified in the description as Director) is responsible for planning and directing clinical research activities 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 research through post-licensure. The role manages the clinical development cycle for late-stage studies, including study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. The position involves developing clinical trials from clinical development strategies; managing trials for investigational and marketed medicines; interpreting and communicating study findings to inform safety and efficacy decisions, regulatory applications, study reports, and publications; and contributing to internal and joint research teams. The Director may collaborate with Clinical Scientists and cross-functional experts in commercialization, regulatory affairs, statistics, and manufacturing, and support business development assessments of external opportunities. The role also requires maintaining current scientific expertise, identifying and engaging qualified investigators, and attending scientific meetings. Work may include authoring development documents, presentations, budgets, and position papers; facilitating collaborations with researchers worldwide; and approximately 20% business travel. The posting lists the work arrangement as hybrid and the primary location as Rahway, New Jersey.
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 a background in biomedical research.
- Strong interpersonal skills and ability to function in a team environment.
- Strong verbal and written communication and presentation skills.
Nice To Haves
- Board certified or eligible in Cardiology (adult or pediatric), Endocrinology, Nephrology, or a related discipline.
- Prior specific experience in clinical research.
- Prior publication experience.
Responsibilities
- Plan clinical trials, including their design, operational plans, and settings, based on clinical development strategies.
- Monitor and manage ongoing and 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 focused on developing new compounds and further studying 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 appropriate corporate personnel are informed about study progress, competitor drugs, and relevant internal and external scientific opinions.
- Maintain knowledge of scientific developments, including new findings and research methodologies, in the area of expertise.
- Identify strong scientific and operational investigators and establish communications with prominent clinical investigators who can assist in evaluating the company's medicines.
- Attend relevant 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 approximately 20% of the time to manage future or ongoing clinical research projects.
Benefits
- Medical insurance
- Dental insurance
- Vision healthcare
- Other insurance benefits for employees and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate days
- Sick days
- Eligibility for an annual bonus and long-term incentive, if applicable
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What This Job Offers
Job Type
Full-time
Career Level
Principal
Education Level
Ph.D. or professional degree
