Senior Principal Scientist, Clinical Research

Job Description The Senior Clinical Director (Senior 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.

Specifically, The Senior 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 Senior 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

Assist the Executive 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 their areas of responsibility.

The Senior Clinical Director is responsible for maintaining a strong scientific fund of knowledge by:

Maintaining awareness of scientific developments within their 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 their competency and to maintain awareness of research activities in their area of responsibility.

To accomplish these goals, the Senior 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.

EducationM.D., D.O., M.D./PhD, or D.O./PhD Required education and experience Minimum of 5 years of clinical and/or development experience (academia, clinical medicine, and/or corporate clinical development)
Minimum of 3 years of industry experience in drug development or biomedical research experience in academia

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 Judgment, Clinical Medicine, Clinical Research Management, Clinical Trial Development, Data Analysis, Decision Making, Ethical Standards, Intellectual Curiosity, Interdisciplinary Problem Solving, Mentorship, Regulatory Compliance, Scientific Consulting, Scientific Publications, Strategic Planning, Vaccinology Preferred

Skills:

Current Employees apply HERE Current Contingent Workers apply HEREUS and Puerto Rico Residents Only:

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