Senior Principal Scientist, Clinical Research, Immunology
About The Position
The Senior Director (Sr. Principal Scientist) holds primary responsibility for the strategic planning and direction of clinical research activities involving investigational compounds in Immunology. This role focuses on late-stage development, managing the entire clinical development cycle from determining appropriate disease indications to study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. Key aspects include evaluating pre-clinical and translational work for early clinical development plans and Investigational New Drug applications, providing clinical development support for business development assessments, and developing clinical development strategies for investigational drugs and planning clinical trials. The Senior Director monitors and manages ongoing clinical trials, analyzes and summarizes clinical findings for safety, efficacy, new drug applications, clinical study reports, or publication, and participates in internal and joint research project teams. The role may involve supervising Clinical Scientists, collaborating with cross-functional experts in commercialization, regulatory affairs, statistics, and manufacturing, and assisting the Executive Director in keeping corporate personnel informed. Maintaining a strong scientific fund of knowledge is crucial, requiring awareness of scientific developments, identification of strong investigators, and establishing collaborative relationships with external experts in Rheumatology, Gastroenterology, Dermatology, and pulmonary disease. The Senior Director is expected to attend scientific meetings, author detailed development documents, presentations, budgets, and position papers, and facilitate collaborations with external researchers globally. Travel for company business is estimated at approximately twenty percent.
Requirements
- M.D., D.O., M.D./PhD, or D.O./PhD.
- Experience in the design and/or execution of phase 2 or 3 clinical trials specifically in Immunology (Rheumatology, Gastroenterology or Dermatology)
- Minimum of 3 years of clinical medicine experience
- Minimum of 5 years of industry experience in drug development
- Demonstrated record of scientific scholarship and achievement
- Strong interpersonal skills, as well0 as the ability to work collaboratively in a cross-functional team environment
Responsibilities
- Strategic planning and directing clinical research activities involving investigational compounds in Immunology
- Managing 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
- 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
- Participation in internal and joint internal/external research project teams relevant to the development of new compounds
- 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
- Assist the Executive Director 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
- 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, Gastroenterology, Dermatology, and pulmonary disease, 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
- 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
Benefits
- medical healthcare benefits
- dental healthcare benefits
- vision healthcare benefits
- other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate days
- sick days
- annual bonus
- long-term incentive
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
