Study Director I - Metabolism

Labcorp is a global leader in laboratory services, providing insights and answers that help healthcare providers, patients, researchers, pharmaceutical companies, and health systems make confident decisions and improve outcomes. Through unparalleled science, data, technology, and a laboratory network, we advance diagnostics, accelerate innovation, and address critical health challenges. We leverage advanced technologies, digital solutions, and data-driven innovation to enhance operations and deliver value to customers and patients. With global scale and deep expertise, you’ll have the opportunity to do meaningful work, grow your career, and impact health worldwide.

About the role

The Study Director I is responsible for managing the design, conduct, and reporting of studies to meet scientific, regulatory, and client requirements in a fast-paced environment. As the single point of study control, this role has overall responsibility for the scientific, technical, and regulatory conduct of studies, including interpretation, documentation, and reporting of results. Close and regular liaison with the client is essential.

Responsibilities

• Coordinate efforts of the study team.
• Develop protocols and ensure protocol compliance with SOPs, GLPs, and regulatory agency guidelines, including any approved changes.
• Ensure test and control articles are available, tested for identity, and handled safely, with precautions communicated to operational areas.
• Review cost estimates to include all protocol/amendment-driven work scope specifications.
• Monitor the financial status of ongoing studies.
• Oversee study progress and status, ensuring accurate recording and verification of all experimental data, including unanticipated responses.
• Direct preparation of reports, ensure compliance with protocol and regulatory requirements, and submit them to the client.
• Participate in and may host client visits.

Requirements

• Bachelor of Science degree with 5+ years of research experience or Master of Science degree with 2+ years of research experience.
• Awareness of requirements for working within GLP, GCP, and GMP environments.
• Basic understanding of the drug development process, regulatory requirements, and scientific techniques for standard metabolism studies.
• Strong client relationship-building and management skills.
• Effective verbal and written communication skills.
• Strong attention to detail, organization, and time management.
• Experience in scientific presentations and preparing scientific publications.
• Previous experience in a feeder role for a study director, with skills in relevant study types.
• Data interpretation and report writing experience.
• Working knowledge of MS Word, Excel, PowerPoint, and general IT skills.

Preferred Qualifications

• PhD degree.
• 2+ years of experience with In vivo Pharmacokinetics (PK).

Benefits

• Comprehensive benefits for employees working 20+ hours per week, including:
  • Medical, dental, and vision coverage.
  • Life, short-term disability (STD), and long-term disability (LTD) insurance.
  • 401(k) plan.
  • Paid Time Off (PTO) or Flexible Time Off (FTO).
  • Tuition reimbursement.
  • Employee Stock Purchase Plan.
• Relocation assistance available.