Senior Study Director - ADME Metabolite Identification

Job Responsibilities

• The Senior Study Director will have extensive Met-ID experience and is responsible for managing the design, conduct and reporting of ADME studies to meet scientific, regulatory and client requirements.
• The Senior Study Director is the single point of study control and has overall responsibility for the scientific, technical and regulatory conduct of studies as well as for the interpretation, documentation and reporting of results.
• Close and regular liaison with the client is of primary importance.
• Ensure that studies are performed to the required scientific, regulatory and client standards, in accordance with the study protocol and Labcorp standard operating procedures.
• Understands Study Director (SD), Principal Investigator (PI), and Contributing Scientist (CS) responsibilities and the organization of multi-site studies.
• Consults with SD/PI/CS colleagues to determine project requirements and plan accordingly, reviews protocol changes and communicate to client and management as necessary.
• Applies up to date knowledge and application of current GLP, GCP, GMP and regulatory guidelines relevant to study conduct.
• Capable of directing simple and complex studies alike.
• Uses knowledge of relevant assays and general expertise in the drug development process to offer guidance and suggestions on study design to meet client’s requirements, and plans accordingly (timelines, critical deadlines, etc.).
• Prepares and completes study documents in partnership with study coordinators to meet client and regulatory requirements (outlines, protocols, reports, etc.).
• Ensures final report is compliant with SOPs and regulatory guidelines.
• Manage projects and client interactions.
• Provides clients with regular progress updates and ensures their expectations are met.
• Effectively communicates study design, project requirements, and performance expectations to the study team.
• Maintains regular and timely communication within study team including start-up, ongoing, and close-out meetings.
• Ensures that all study communication is documented and maintained.
• Monitors/reviews study progress at all times and anticipate problems that may affect timing and quality.
• Considers & discusses appropriate actions to resolve such problems.
• Issues directives and follows up to ensure compliance with requirements.
• Uses experience in data interpretation to recognize anomalous findings, identify the route cause and to offer solutions.
• Manages study changes and ensures all additional costs are captured.
• Apply company procedures for financial, resource and contracting requirements.
• Acts as scientific reviewer in evaluating and interpreting data for study reports, and reviews technical validity of study results with occasional help from more experienced scientists.
• Consistently meets on time delivery targets (protocols, results, reports).
• Monitors and reviews client satisfaction to provide feedback to team and ensure repeat business.
• Build confidence to win future work across service lines through advice & guidance.
• Manages the CAIR process; leads discussions, writes documentation, manages resolution and client satisfaction.

Minimum Qualifications

• Master of Science degree in biochemistry, pharmacology, or toxicology
• 10 or more years of experience in the ADME drug development process, regulatory requirements and the scientific techniques of Metabolism studies including Metabolite Identification.
• 7 or more years of experience as a Study Director or Study Manager.

Preferred Qualifications

Ph.D. in biochemistry, pharmacology, toxicology

Additional Job Standards

• Ability to demonstrate in-depth knowledge of relevant assays and develop general expertise in the drug development process.
• Understands current technical applications in field, and familiar with the use of standard laboratory equipment and analytical instrumentation.
• Ability to demonstrate broad level of scientific knowledge in chosen field.
• Independently develops a wider understanding of scientific disciplines.
• Share scientific knowledge through internal and external publications (co-author), presentations, lectures, and events.
• Ability to function as Scientific reviewer for standard protocols, data sets, and reports for peers prior to Sponsor review.
• Ability to proactively and effectively communicate with internal and external clients.
• Ability to constructively participate in Study Direction, team, and department meetings.
• Ability to develop relationships and collaborate constructively with other Labcorp depts such as project/program management.
• Supplies information to assist in the preparation of the preliminary cost and duration discussions.
• Ability to organize and host client visits.