Senior Study Director - ADME Metabolite Identification
Core
Managing the design, conduct, and reporting of ADME (Absorption, Distribution, Metabolism, and Excretion) studies with a specific focus on Metabolite Identification to meet scientific, regulatory, and client requirements.
Role type
Senior Study Director (ADME Metabolite Identification)
Builds
ADME study protocols, reports, and data interpretations for pharmaceutical clients
Domain
Pharmaceutical R&D / Drug Development / ADME / Metabolite Identification
Required skills
ADME study design and conduct, Metabolite Identification, GLP/GCP/GMP compliance, regulatory guidelines, data interpretation, project management, client liaison, study reporting, root cause analysis
Preferred skills
Ph.D. in biochemistry, pharmacology, or toxicology, experience in scientific publications, advanced knowledge of analytical instrumentation
Technologies
Standard laboratory equipment, analytical instrumentation
Responsibilities
Manage the design, conduct, and reporting of ADME studies; Ensure studies comply with GLP, GCP, GMP, and regulatory guidelines; Liaise with clients to manage expectations and provide progress updates; Review and interpret study data to identify anomalous findings and root causes; Prepare study documents including protocols and final reports; Monitor study progress and resolve issues to meet timelines; Manage study changes and associated costs; Act as a scientific reviewer for study reports and data sets.
Seniority
Senior, hands-on IC