Study Director – ADME In Vitro Screening

Job Summary

The Study Director is responsible for managing the design, conduct and reporting of studies to meet scientific, regulatory and client requirements. The 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.

The Study Director will demonstrate competence in directing studies of intermediate complexity in design and scope. The majority of studies undertaken will be non-GLP studies and routine & more complex GLP, GCP or GMP studies.

• Ensures 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), Principle 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 communicates 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.
• Manages 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 anticipates problems that may affect timing, quality.
• Considers & discusses appropriate actions to resolve such problems.
• Issues directives and follows up to ensure compliance to 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.
• Applies 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.
• Builds confidence to win future work across service lines through advice & guidance.
• Manages the CAIR process; leads discussions, writes documentation, manages resolution and client satisfaction.

• Experience in the drug development process, knowledge of regulatory requirements and the scientific techniques of Metabolism studies required.
• Experience of client management and technical expertise in the relevant business line.
• PhD or equivalent, or MSc/BSc degree in an appropriate scientific discipline with some research experience in drug development or similar field.
• Knowledge of requirements for working within a GLP, GCP and GMP (as appropriate) environment.
• Previous data interpretation and report writing experience.
• Working knowledge of software (eg, MS Word, Excel), specialty applications (eg, Analyst, Sigmaplot, Win Nonlin Phoenix), and general IT skills.

Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including:
Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time…