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Job description
Job Description
The Director (Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed medicines in the Metabolism section of the Atherosclerosis & Metabolism therapeutic area, with a focus on obesity and obesity-related disorders.
Our company’s Atherosclerosis & Metabolism medicines span all phases of clinical development (pre-clinical to post-licensure).
The Director will manage the entire cycle of clinical development for late-stage studies, including study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.
Specifically, The Director will be responsible for:
Planning clinical trials (design, operational plans, settings) based on these clinical development strategies
Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed drugs
Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication
Participation in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds
Support of business development assessments of external opportunities
The Director will:
Collaborate with the Clinical Scientists in the execution of clinical studies.
Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects
Assist the team in ensuring that appropriate Corporate personnel are informed of the progress of studies of our company and competitors’ drugs and internal and external expert opinion on scientific questions relevant to his/her areas of responsibility
The Director is responsible for maintaining a strong scientific fund of knowledge by:
Maintaining awareness of scientific developments within his/her area of expertise, in terms of new scientific findings and research methodologies
Identifying scientifically and operationally strong investigators who can assist in the development of our company’s investigational and marketed drugs
Establishing communications with prominent clinical investigators in his/her particular field of interest, particularly those who will be willing and able to assist in the evaluation of our company’s drugs
Attending appropriate scientific meetings to maintain his or her competency and to maintain awareness of research activities in his/her area of responsibility
To accomplish these goals, the Director may:
Author detailed development documents, presentations, and position papers for internal and external audiences
Facilitate collaborations with external researchers around the world
Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects
Qualifications
Education
M.D or M.D./Ph.D.
Required
Must have experience in industry or faculty in academia
Minimum of 3 years of experience in clinical medicine
Minimum of 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, as well as the ability to function in a team environment
Strong verbal and written communication and presentation skills
Preferred
Board Certified or Eligible in Endocrinology, Gastroenterology, Hepatology, Cardiology, Nephrology or related discipline
Prior specific experience in clinical research and prior publication
Required Skills
Clinical Development
Clinical Research
Clinical Trial Planning
Cross-Functional Teamwork
Liver Diseases
Obesity
Compensation and Benefits
The salary range for this role is $255,800.00 – $402,700.00.
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include:
Medical, dental, vision healthcare and other insurance benefits for employee and family
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
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Worksite address
rahway, NJ, 07065, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.