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Job description
Job Description
The Clinical Director (Principal Scientist) has primary responsibility for the strategic planning and directing clinical research activities involving investigational compounds in Immunology. With a focus on late-stage development, the Clinical Director will manage the entire cycle of clinical development, including determination of appropriate disease indications to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.
Specifically, The Clinical Director May Be Responsible For
Evaluating pre-clinical and translational work for the purpose of generating the early clinical development plan and Investigational New Drug applications.
Providing clinical development support of business development assessments of external opportunities to grow the Immunology Pipeline
Developing clinical development strategies for investigational drugs and 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 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; and
Participation in internal and joint internal/external research project teams relevant to the development of new compounds
The Clinical Director May
Supervise the activities of 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; and assist the Senior Director, Associate Vice‑President/Vice‑President and Product Development Team Lead in ensuring that appropriate corporate personnel is 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 Clinical 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, research methodologies
Identification of scientifically and operationally strong investigators who can assist in the development of our company's investigational drugs in Immunology
Establishing collaborative relationships with external experts in Rheumatology diseases, particularly those whose research focus and expertise can inform and assist the evaluation of the company's investigational 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 Clinical Director May
Author detailed development documents, presentations, budgets, 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., D.O., M.D./Ph.D, or D.O./Ph.D.
Required Education And Experience
Minimum of 5 years of clinical and/or development experience (academia, clinical medicine, and/or corporate clinical development).
Demonstrated record of scientific scholarship and achievement
Prior experience in design and execution of phase 2 or 3 clinical trials in rheumatologic diseases is preferred
Strong interpersonal skills, as well as the ability to work collaboratively in a cross-functional team environment
Required Skills
Clinical Development, Clinical Research, Clinical Trial Planning, Cross-Functional Teamwork, Immunology, Rheumatology
US And Puerto Rico Residents Only
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.
Requirements
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts 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, and compassionate and sick days. More information about benefits is available at
San Francisco Residents Only
We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only
We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
Employee Status
Regular
Relocation
Domestic
VISA Sponsorship
No
Travel Requirements
25%
Flexible Work Arrangements
Hybrid
Shift
Not Indicated
Valid Driving License
No
Hazardous Material(s)
n/a
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Worksite address
rahway, NJ, 07065, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.