Senior Principal Scientist, Clinical Research, Immunology - Ophthalmology
About The Position
The Senior Director (Sr. 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 Senior 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. The Senior Director may supervise the activities of Clinical Scientists in the execution of clinical studies and work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects. They are responsible for maintaining a strong scientific fund of knowledge by staying aware of scientific developments, identifying strong investigators, and establishing collaborative relationships with external experts. The Senior Director may author detailed development documents, presentations, budgets, and position papers, and facilitate collaborations with external researchers. Travel is required approximately twenty (20) percent of the time.
Requirements
- M.D., D.O., M.D./Ph.D, or D.O./PhD.
- Experience in the design and/or execution of phase 2 or 3 clinical trials specifically in Immunology.
- 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 well as the ability to work collaboratively in a cross-functional team environment.
- Clinical Development
- Clinical Documentation
- Clinical Immunology
- Clinical Judgment
- Clinical Medicine
- Clinical Research Management
- Clinical Sciences
- Clinical Studies
- Clinical Trial Development
- Data Analysis
- Drug Development
- Hiring
- Ophthalmology
- Rare Diseases
- Scientific Consulting
- Strategic Planning
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, 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 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.
- Supervising the activities of Clinical Scientists in the execution of clinical studies.
- Working closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects.
- Assisting the Executive Director 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.
- 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, Pulmonary, or rare 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.
- Authoring detailed development documents, presentations, budgets, and position papers for internal and external audiences.
- Facilitating collaborations with external researchers around the world.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and 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
