Senior Study Director - ADME Metabolite Identification

Labcorp•Madison, WI

About The Position

Labcorp is seeking a Senior Study Director – ADME Metabolite Identification to join its team in Madison, Wisconsin. The role manages the design, conduct, and reporting of ADME studies in accordance with scientific, regulatory, and client requirements. The Senior Study Director serves as the single point of study control and has overall responsibility for the scientific, technical, and regulatory conduct of studies, as well as interpretation, documentation, and reporting of results. Regular client liaison is a primary part of the position. The role applies current GLP, GCP, GMP, and other relevant regulatory guidelines; provides guidance on study design; prepares study documentation; manages project timelines, resources, costs, and client interactions; and communicates requirements and expectations to study teams. The Senior Study Director monitors study progress and quality, addresses issues, reviews and interprets data, ensures compliant and timely reports, and manages the CAIR process. The position also supports client satisfaction and future business through scientific advice, collaboration, and effective communication. Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits, including medical, dental, vision, life, short- and long-term disability, 401(k), paid time off or flexible time off, tuition reimbursement, and an employee stock purchase plan. Relocation assistance is available.

Requirements

Master of Science degree in biochemistry, pharmacology, or toxicology.
At least 10 years of experience in the ADME drug development process, regulatory requirements, and scientific techniques for metabolism studies, including metabolite identification.
At least 7 years of experience as a Study Director or Study Manager.
In-depth knowledge of relevant assays and general expertise in the drug development process.
Knowledge of current technical applications in the field and familiarity with standard laboratory equipment and analytical instrumentation.
Broad scientific knowledge in the chosen field and the ability to independently develop a wider understanding of scientific disciplines.
Ability to function as a scientific reviewer of standard protocols, data sets, and reports for peers before sponsor review.
Ability to communicate proactively and effectively with internal and external clients.
Ability to participate constructively in study direction, team, and department meetings.
Ability to develop relationships and collaborate constructively with other Labcorp departments.

Nice To Haves

Ph.D. in biochemistry, pharmacology, or toxicology.

Responsibilities

Manage the design, conduct, and reporting of ADME studies in accordance with scientific, regulatory, and client requirements.
Serve as the single point of study control and take overall responsibility for the scientific, technical, and regulatory conduct of studies and the interpretation, documentation, and reporting of results.
Ensure studies follow the study protocol, Labcorp standard operating procedures, and required scientific, regulatory, and client standards.
Consult with Study Director, Principal Investigator, and Contributing Scientist colleagues about project requirements and planning; review protocol changes and communicate them to clients and management as needed.
Apply current GLP, GCP, GMP, and relevant regulatory guidelines, and direct simple and complex studies.
Use knowledge of relevant assays and drug development to advise on study design, timelines, and critical deadlines.
Prepare study documents, including outlines, protocols, and reports, in partnership with study coordinators, and ensure final reports comply with SOPs and regulatory guidelines.
Manage projects and client interactions, provide regular progress updates, and work to meet client expectations.
Communicate study design, requirements, and performance expectations to study teams; maintain timely communication and document study communications.
Monitor study progress, anticipate issues that could affect timing or quality, discuss and implement solutions, issue directives, and follow up on compliance.
Interpret data, recognize anomalous findings, identify root causes, and propose solutions.
Manage study changes, capture additional costs, and apply company procedures for financial, resource, and contracting requirements.
Act as a scientific reviewer, evaluate and interpret data for study reports, and review the technical validity of study results.
Meet on-time delivery targets for protocols, results, and reports.
Monitor client satisfaction, provide feedback to the team, and help build confidence for future work across service lines through advice and guidance.
Manage the CAIR process, including leading discussions, writing documentation, managing resolution, and supporting client satisfaction.
Share scientific knowledge through co-authored publications, presentations, lectures, and events.
Collaborate with other Labcorp departments, including project and program management, and provide information for preliminary cost and duration discussions.
Organize and host client visits.