Covance

Study Director III - Immunotox

CN-31-Shanghai
Job Number
2017-16438
Job Category
Immunology & Immunotoxicity
Position Type
Full-Time

Job Overview

  • May serve as a Study Director for immunotoxicology studies, as described in the GLPs. Has overall responsibility for the technical conduct of a study as well as for the analysis and interpretation of data, documentation, and reporting of results.
  • Serves as a Principal Investigator/Contributing Scientist on Toxicology studies that include an immunotoxicology component. Has overall responsibility for the technical conduct of the immunotoxicology portion of the study as well as for the interpretation, analysis, documentation, and reporting of results into a contributor report.
  • Learns to act as a scientific contact for any client queries on immunotoxicology–related matters.
  • May plan, design, and lead teams to conduct complex method development/feasibility studies to generate high quality scientific results on behalf of Covance clients and helps develops new techniques, and instrumentation for new ventures in immunotoxicology.
  • Develops protocols and ensures that the protocol, including any changes, is approved and is in compliance with the appropriate SOPs, GLPs, and regulatory agency guidelines.
  • Works with Safety Assessment Management, client service, program management, and study direction to evaluate immunotoxicology proposals, evaluate feasibility, and provide recommendations to clients.
  • Follows GLPs and other regulatory requirements to ensure the acceptability of Covance immunotoxicology data.
  • May monitor financial status of ongoing studies, programs and I&I research and development.
  • Monitors progress and status of assigned studies and research projects. Ensures that all experimental data, including observations of unanticipated responses to the test system, are accurately recorded and verified.
  • Directs analysis of data, interpretation of data, preparation of reports, ensures compliance with protocol and regulatory requirements, and submits them to the client.
  • Participates in client visits.
  • May assist in implementation and validate new techniques and instrumentation to improve immunotoxicology operations.
  • Through liaison with Global Clinical Pathology Services (CPS) and Immunology Innovation team, ensures that method development activities are fully documented, observing the highest standards of Good Scientific Practice.
  • Ensure validation documentation and testing of data capture systems for immunotoxicology data match both Covance company policies and the standards expected by external clients and global regulators.
  • May assist in troubleshooting and solving challenging technical problems, dependent on issue and site.
  • Assists in assessing client interest and technical feasibility of new immunotoxicology assays.
  • Directs and conducts both fundamental and general application studies in the area of immunotoxicology.
  • Reviews I&I data acquired by the CPS or I&I operational groups where necessary.
  • May author scientific papers, which are published in peer reviewed journals, and presented in scientific meetings.
  • May perform scientific mentoring activities (e.g.; training study specific techniques, assisting with complex analytical work/problem solving, and presenting technique seminars).
  • Contributes to long-range planning and technical policies of the department.
  • Keeps management informed of problems/issues as they unfold in assigned studies.
  • Performs other related duties as assigned

Education/Qualifications

  • PhD or DMV preferred, or equivalent degree plus 3-5 years of experience in immunology, immunotoxicology or related field, or Master’s or Bachelor’s degree in related discipline plus 7-10 years of experience.  Experience may be substituted for education.

Experience

  • Prior experience in Immunology / Immunotoxicology (I&I) procedures, method development, and validation required.
  • Knowledge of I&I study design and conduct.
  • Strong customer service skills.
  • Demonstrated ability to interact effectively with all staff and management levels.
  • Strong problem solving and decision making skills.
  • Strong English writing and communication skills.
  • Skilled in performing scientific presentations and preparing scientific publications.
  • Knowledge of computers and programs (e.g., word processing and spreadsheet applications).

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