
Study Director - Immunopathology
Charles River Laboratories, Reno, NV, United States
Job Summary
Responsible for overseeing the study conduct of assigned nonclinical research studies of basic complexity (including tissue cross-reactivity [TCR] and immunotoxicology studies) within Safety Assessment. Oversight includes study management, interpretation, evaluation, and preparation of reports from the data collected during these studies, assuring regulatory compliance, communication with sponsor representatives, and initiation of contact with potential clients. Familiarity with study costs and impact of changes is required. Responsibilities
Function as an independent Study Director in accordance with the applicable Good Laboratory Practices (GLPs). Design, write, review and edit Study Protocols, amendments, and study schedules that define and schedule all study activities. Oversee and coordinate with laboratory management all aspects of study procedures, whether performed within the department or by service departments. Ensure that projects are performed according to Standard Operating Procedures and Good Laboratory Practice regulations and are aware of appropriate regulations, guidelines and guidance documents. Write, review and edit draft or final reports that document all study related procedures and results. Provide prompt verbal and/or written communication with Sponsors on study related business. Understand regulations and GLPs as they relate to the primary area of focus. Understand the study process from proposal to report. Qualifications
Education:
Bachelor's degree (B.A./B.S.) or equivalent in a laboratory science or related discipline required. Experience:
Minimum of 2 years related experience in contract research or pharmaceutical industry, including at least 1 year as a Research Analyst, Research Associate or equivalent role. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. Benefits
Benefits may include bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work‑life balance flexibility. Equal Employment Opportunity
Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws. It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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Responsible for overseeing the study conduct of assigned nonclinical research studies of basic complexity (including tissue cross-reactivity [TCR] and immunotoxicology studies) within Safety Assessment. Oversight includes study management, interpretation, evaluation, and preparation of reports from the data collected during these studies, assuring regulatory compliance, communication with sponsor representatives, and initiation of contact with potential clients. Familiarity with study costs and impact of changes is required. Responsibilities
Function as an independent Study Director in accordance with the applicable Good Laboratory Practices (GLPs). Design, write, review and edit Study Protocols, amendments, and study schedules that define and schedule all study activities. Oversee and coordinate with laboratory management all aspects of study procedures, whether performed within the department or by service departments. Ensure that projects are performed according to Standard Operating Procedures and Good Laboratory Practice regulations and are aware of appropriate regulations, guidelines and guidance documents. Write, review and edit draft or final reports that document all study related procedures and results. Provide prompt verbal and/or written communication with Sponsors on study related business. Understand regulations and GLPs as they relate to the primary area of focus. Understand the study process from proposal to report. Qualifications
Education:
Bachelor's degree (B.A./B.S.) or equivalent in a laboratory science or related discipline required. Experience:
Minimum of 2 years related experience in contract research or pharmaceutical industry, including at least 1 year as a Research Analyst, Research Associate or equivalent role. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. Benefits
Benefits may include bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work‑life balance flexibility. Equal Employment Opportunity
Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws. It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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