A Study Director (E4) provides operational management and reporting for Toxicology non-GLP nonclinical safety studies of drug candidates and marketed products in the department of Safety Assessment (SA). This person is responsible for the overall conduct of the study, and is thus an operational expert on study process with strong communication skills and the ability to handle several multifaceted studies at once. The Study Director will work closely with the Scientific Researcher that executes the in vivo study in the laboratory.
The responsibilities for a Study Director include:
Effectively manage, develop, track study timelines for non-GLP nonclinical safety studies.
Leverage scientific and operational knowledge to ccollaborate with Toxicologist, Pathologist, and/or Project Team in the design of toxicology studies
Prepare nonclinical protocols
Calculate and coordinate of test article
Coordinate across multiple departments for study support such as sample analysis and procedural aid
Address urgent matters when unexpected events or issues on study arise
Communicate study events and data to the scientists
Confirm all study data results and methodology
Generate draft toxicology reports and management of review and interpretation by scientists
Finalize toxicology report and assistance with regulatory submission as needed
Accomplish tasks using established guidelines and procedures
Provide in vivo study support as needed
Adhere to departmental SOPs to ensure study integrity and quality
Demonstrates clear and concise verbal and written communication. Effectively negotiates and facilitates open communication across all departments.
Formally presents at group, department and project team meetings
May supervise, matrix manage, and/or mentor other employees
Assist in the accomplishment of department and/or team goals
Recognized leader in the department
Performs other duties as assigned
Education: Bachelor or higher degree in scientific-related field, and at least 8 years of experience in toxicology, pharmacology, pharmacokinetics, immunology, biological sciences or related discipline; or at least 15-year equivalent experience
Proficient with MS Office, Instem Provantis application, and other computer applications a plus
Solid understanding of and experience with in vivo study design, data management systems, procedures and documentation practices
Must be detail oriented, with ability to multi-task and work in both an individual and team-based environment
Effective communicator both verbally and in writing
Excellent interpersonal, organizational and problem-solving skills required to manage multiple studies at different phases in parallel
Ability to administer test article PO, IV, and SC in rodent models; collect blood samples via tail vein, cardiac puncture, jugular vein, descending aorta; and collect routine tissues desired
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