Updated 9 days ago

Senior Study Director

Somerset, NJ 08873
Full-time

Job Overview:

Looking for a career that will make an impact on patient lives? Labcorp Drug Development continues to grow! We have a great opportunity for a SENIOR STUDY DIRECTOR to join our Preclinical Toxicology Study Direction team at our Somerset, NJ site.  Our work in developing new pharmaceutical solutions has an incredible impact on the lives of millions worldwide.  Be a part of this life-saving work.

 

This role:

  • Serve as a Study Director for a wide range of Safety Assessment studies, as described in the GLPs. Has overall responsibility for the technical conduct of a study as well as for the interpretation, analysis, documentation, and reporting of results.
  • Coordinates efforts of the study team.
  • 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 client service, program management, and study direction to evaluate proposals, evaluate feasibility, and provide recommendations to clients.
  • Reviews cost estimates to ensure that all protocol/amendment driven workscope specifications have been included in the price estimation.
  • Understands financial status of ongoing studies.
  • Monitors progress and status of assigned studies. Ensures that all experimental data, including observations of unanticipated responses to the test system, are accurately recorded and verified.
  • Directs analysis of data, preparation of reports, ensures compliance with protocol and regulatory requirements, and submits them to the client.
  • Directs analysis of data, preparation of reports, ensures compliance with protocol and regulatory requirements, and submits them to the client.
  • May peer review protocols and reports for other Study Directors.
  • Leads and sponsors client visits.
  • Leads a scientific team to conduct complex and challenging feasibility/development studies.
  • Implements and validates new techniques and instrumentation to improve operations.
  • Provides a leadership role in troubleshooting and solving challenging technical problems.
  • Assesses client interest and technical feasibility of new assays.
  • May direct methods development/validation studies, assisting in the development of new technologies in Toxicology or enhancing existing ones and assists in marketing new capabilities.
  • Conducts scientific meetings and provides leadership in scientific organizations, including publishing research findings and attaining peer recognition through contributing to the field of Toxicology.
  • Author scientific papers, which are published in peer reviewed journals, and presented in scientific meetings.
  • Performs 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.

  

There is no better time to join us!

Patients can’t wait. Neither can we.

 

#LI-TC1

Education/Qualifications:

Required:

PhD in toxicology or related field preferred, BSc or MSc or equivalent degree in toxicology or related field.  Experience Relevant experience may be substituted for years of related experience.

Board certification in toxicology is desired. Home Office License desired (if appropriate).

Experience:

Required:

  • 3 to five years of safety assessment study direction experience and drug development experience
  • Highly skilled in conducting research, data interpretation, and writing reports.
  • Highly skilled in performing scientific presentation and preparing scientific publications
  • Knowledge and/or experience in drug development field.

 

 

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Posting ID: 632495245Posted: 2021-07-23Job Title: Senior Study Director