Senior Study Director - ADME Metabolite Identification

Labcorp•Madison, WI

10d

About The Position

Labcorp is seeking a Senior Study Director with extensive metabolite identification (Met-ID) experience to join its team in Madison, Wisconsin. The role manages the design, conduct, and reporting of ADME studies to meet scientific, regulatory, and client requirements. The Senior Study Director serves as the single point of study control and is responsible for the scientific, technical, and regulatory conduct of studies, as well as interpretation, documentation, and reporting of results. Regular client liaison is a key aspect of the position. The role ensures studies follow protocols, Labcorp standard operating procedures, and applicable scientific, regulatory, and client standards. It requires applying current GLP, GCP, GMP, and other relevant regulatory guidance; coordinating with Study Directors, Principal Investigators, and Contributing Scientists; planning study requirements and timelines; and preparing study documents with study coordinators. The Senior Study Director manages projects and client interactions, communicates requirements and progress to clients and study teams, monitors study progress and quality, resolves issues, manages study changes and associated costs, and reviews and interprets data and reports. The position also involves meeting delivery targets, monitoring client satisfaction, contributing scientific advice to support future work, managing the CAIR process, and sharing scientific knowledge through publications, presentations, lectures, and events. 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 ability to develop 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 ability to independently develop understanding of wider scientific disciplines.
Ability to communicate proactively and effectively with internal and external clients.
Ability to collaborate constructively with other departments and participate in study direction, team, and department meetings.

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 study conduct, interpretation, documentation, and reporting.
Maintain close and regular liaison with clients and provide progress updates to ensure expectations are met.
Ensure studies comply with protocols, Labcorp standard operating procedures, and applicable scientific and regulatory standards.
Consult with Study Director, Principal Investigator, and Contributing Scientist colleagues to establish project requirements and plans, including for multi-site studies.
Review protocol changes and communicate them to clients and management as necessary.
Apply current GLP, GCP, GMP, and other relevant regulatory guidance to study conduct.
Guide study design using knowledge of relevant assays and the drug development process; plan timelines and critical deadlines.
Prepare study documents, including outlines, protocols, and reports, with study coordinators.
Ensure final reports comply with standard operating procedures and regulatory guidelines.
Communicate study design, project requirements, and performance expectations to the study team; conduct start-up, ongoing, and close-out meetings and document study communications.
Monitor study progress, anticipate issues affecting timing or quality, discuss and implement resolutions, and follow up to ensure requirements are met.
Interpret data, identify anomalous findings and their root causes, and offer solutions.
Manage study changes and ensure additional costs are captured; apply company procedures for financial, resource, and contracting requirements.
Act as a scientific reviewer, evaluate and interpret data for 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 support repeat business and future work across service lines.
Manage the CAIR process, including leading discussions, preparing documentation, resolving issues, and supporting client satisfaction.
Share scientific knowledge through internal and external publications, presentations, lectures, and events.
Review standard protocols, data sets, and reports for peers before Sponsor review.
Collaborate with other Labcorp departments, including project and program management, and contribute to study direction, team, and department meetings.
Provide information for preliminary cost and duration discussions and organize and host client visits.