Principal Scientist (Director), Clinical Research, Immunology
About The Position
The Clinical Director (Principal Scientist) is responsible for strategically planning and directing clinical research activities involving investigational compounds in Immunology, with a focus on late-stage development. The role manages the clinical development cycle, from choosing disease indications and designing studies through study initiation, execution, monitoring, analysis, regulatory filing, and publication. The position may evaluate preclinical and translational research to develop early clinical plans and Investigational New Drug applications; support business-development assessments of external opportunities; develop strategies and plans for clinical trials; monitor and manage trials; analyze and summarize findings for safety, efficacy, regulatory submissions, study reports, and publications; and participate in internal and joint research teams. The Clinical Director may supervise Clinical Scientists and work with experts across commercialization, regulatory affairs, statistics, and manufacturing, while supporting senior leaders and product teams with updates on research progress, competitor drugs, and relevant scientific opinion. The role requires maintaining scientific expertise, identifying strong investigators, building collaborative relationships with external experts in rheumatology, and attending relevant scientific meetings. The Clinical Director may also author development documents, presentations, budgets, and position papers; facilitate collaborations with researchers worldwide; and travel for company business. The position is listed as hybrid, based primarily in Rahway, New Jersey, with 25% travel.
Requirements
- M.D., D.O., M.D./Ph.D., or D.O./Ph.D.
- At least 5 years of clinical and/or development experience in academia, clinical medicine, and/or corporate clinical development.
- Demonstrated record of scientific scholarship and achievement.
- Strong interpersonal skills and ability to collaborate in a cross-functional team environment.
- Skills in clinical development, clinical research, clinical trial planning, cross-functional teamwork, Immunology, and Rheumatology.
Nice To Haves
- Prior experience designing and executing Phase 2 or Phase 3 clinical trials in rheumatologic diseases.
Responsibilities
- Strategically plan and direct clinical research activities for investigational Immunology compounds, with a focus on late-stage development.
- Manage clinical development from indication selection and study design through initiation, execution, monitoring, analysis, regulatory filing, and publication.
- Evaluate preclinical and translational work to develop early clinical development plans and Investigational New Drug applications.
- Provide clinical development support for business-development assessments of external opportunities to grow the Immunology pipeline.
- Develop clinical strategies and plan clinical trials, including their design, operational plans, and settings.
- Monitor and manage ongoing and new clinical trials for investigational 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 involved in developing new compounds.
- Potentially supervise Clinical Scientists in executing clinical studies.
- Collaborate with experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects.
- Assist senior leaders and Product Development Team Leads by communicating study progress, information about competitor drugs, and relevant internal and external scientific opinions.
- Maintain awareness of scientific developments and research methodologies in the area of expertise.
- Identify scientifically and operationally strong investigators and establish collaborative relationships with external rheumatology experts.
- 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 families.
- Retirement benefits, including a 401(k).
- Paid holidays, vacation, compassionate days, and sick days.
- 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
