Study Director, In Vivo Studies, gRED Nonclinical Operations, Safety Assessment

South San Francisco
California, United States of America


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The Position

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.

Responsibilities:

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



Requirements:

  • 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

Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.

At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.


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