Principal Scientist, Clinical Research - Immunology/Dermatology

About the role

The Clinical Director (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 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.

Responsibilities

• 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.
• 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.
• Aiding the Senior 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.

Requirements

Minimum of 5 years of clinical and/or development experience (academia, clinical medicine, and/or corporate clinical development).

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.

Skills

• Allergy and Immunology
• Clinical Development
• Clinical Immunology
• Clinical Research
• Clinical Trials
• Dermatology
• Drug Investigation
• Immunology
• Statistics
• Strategic Planning

Preferred Skills

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• Current Contingent Workers apply HERE
• US And Puerto Rico Residents Only
• Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.
• Please click here if you need an accommodation during the application or hiring process.
• Requirements
• As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.
• As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
• We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds.
• The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment.
• We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Education

M.D., D.O., M.D./PhD, or D.O./PhD Required

Pay

$255,800.00 - $402,700.00

Schedule

Hybrid Shift Not Indicated