Labcorp · 14 hours ago
Study Director - ADME In Vitro Screening
Madison, WI
Full-time
Onsite
Senior LevelLabcorp is a leading global life sciences company that is seeking a Study Director for ADME In Vitro Screening. The Study Director will manage the design, conduct, and reporting of studies to meet scientific, regulatory, and client requirements, ensuring compliance with protocols and guidelines while maintaining client communication and satisfaction.
BiotechnologyHealth CareHospitalLife ScienceMedicalPrecision Medicine
Responsibilities
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
Qualification
Required
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, WinNonlin Phoenix), and general IT skills
Benefits
Medical
Dental
Vision
Life
STD/LTD
401(k)
Paid Time Off (PTO) or Flexible Time Off (FTO)
Tuition Reimbursement
Employee Stock Purchase Plan
Company
Labcorp
Labcorp specializes in providing physicians with laboratory tests.
Founded in 1978
10001+ employees
H1B Sponsorship
Labcorp has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$2.85B2024-09-16Post Ipo Debt· $2B
2019-06-04Post Ipo Debt· $850M
1988-07-15IPO
Leadership Team
Adam Schechter
President and Chief Executive Officer
Bill Haas
SVP, Northeastern US and Canada, Labcorp Diagnostics
Recent News
2026-01-14
Bizjournals.com Feed (2025-11-12 15:43:17)
2026-01-11
Company data provided by crunchbase