Principal Scientist (Director), Clinical Research, Immunology
About The Position
The Clinical Director (Principal Scientist) is primarily responsible for strategic 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, including selection of disease indications and study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. The Clinical Director evaluates preclinical and translational work to develop early clinical development plans and Investigational New Drug applications; supports business development assessments of external opportunities to grow the Immunology pipeline; develops clinical strategies and plans clinical trials; oversees ongoing and new trials; and analyzes and summarizes clinical findings to inform safety and efficacy decisions, regulatory applications, study reports, and publications. The role also participates in internal and joint research project teams. The Clinical Director may supervise Clinical Scientists and collaborates with experts in commercialization, regulatory affairs, statistics, and manufacturing. The role may also assist senior leadership and Product Development Team Leads by communicating study progress, competitor developments, and internal and external expert opinions on relevant scientific questions. The position maintains scientific expertise by tracking developments and research methods, identifying strong investigators, building collaborative relationships with external experts in rheumatologic diseases, and attending scientific meetings. The Clinical Director may author development documents, presentations, budgets, and position papers; facilitate global collaborations; and travel on company business. The posting lists travel requirements of 25% and a hybrid work arrangement.
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 work collaboratively 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
- 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 development strategies for investigational drugs and plan clinical trials, including 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 relevant to developing new compounds.
- Potentially supervise Clinical Scientists in the execution of clinical studies.
- Work with cross-functional experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects.
- Assist senior leadership and Product Development Team Leads in communicating study progress and relevant scientific information about company and competitor drugs.
- 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 experts in rheumatologic diseases.
- Attend 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, and vision healthcare benefits.
- Other insurance benefits for employees and family.
- Retirement benefits, including 401(k).
- Paid holidays.
- Vacation.
- Compassionate 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
