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POSITION SUMMARY

The Study Director I is an individual contributor who is responsible for managing the design, conduct and reporting of non-regulated antibody discovery and generation studies to meet scientific and client requirements. They coordinate the efforts of the study team, lead the interpretation, analysis, documentation, and reporting of results which include productive interactions with management, technical staff, global internal and external clients, and study direction staff.

QUALIFICATIONS:

• Knowledge of the drug development processes, and the scientific techniques of antibody development and antibody-related studies.
• Previous data interpretation and report writing experience.
• Strong client relationship building and management skills.
• Excellent organizational and time management skills
• Good verbal and written communication skills
• Ability to help foster a high professional standard and encourage positive staff relationships.

EDUCATION/EXPERIENCE

• Master’s degree in Life Sciences with 1 to 4 years of relevant scientific or animal study related experience.
• PhD preferred.

• Serve as a Study Director on antibody discovery and generation study designs as determined appropriate by management.
• Coordinates the efforts of the study team.
• Ensures that selected study plan/protocols, including any changes, are scientifically robust (with management/senior scientist input as needed), approved by the client, and are in compliance with the appropriate SOPs, and animal welfare guidelines.
• Monitors progress and status of assigned studies with direction from mentor/management/senior scientists and site veterinary staff. Ensuring that all experimental data, including observations of unanticipated responses to the test system, are accurately recorded, and verified.
• Provides excellent customer care to both internal and external clients, including timely production of high-quality protocols, compiled study progress updates, reports, and other client deliverables.
• Liaises with sponsors and other customers in a timely and professional manner on study related matters, with some direction from senior scientists.
• Learns to review cost estimates to ensure that all protocol/amendment driven work scope specifications have been included in the price estimation.
• Participate in and may host client visits.
• Evaluate and interpret nonclinical data with minimal support.