Pioneering Medicines: Non-Clinical DMPK Operations Specialist (Senior Scientist Level)
Core
Manage and coordinate nonclinical DMPK and toxicology studies by liaising with CROs, internal teams, and subject matter experts to ensure operational excellence and compliance.
Role type
Senior Scientist Level Non-Clinical DMPK Operations Specialist
Builds
Drug discovery and development programs
Domain
Biotechnology / Pharmacokinetics (PK) / Bioanalysis (BA) / ADME / Toxicology
Deliverable
client delivery
Required skills
CRO management, study contract and SOW review, inventory and sample tracking, GLP compliance, regulatory submission documentation, advanced Excel, project milestone tracking
Preferred skills
Advanced degree in Life Sciences or Project Management, experience with immunogenicity studies, knowledge of IND/IB preparation
Technologies
Microsoft Excel, electronic submission tools
Responsibilities
Coordinate study proposals, budgets, and timelines across DMPK and toxicology functions; Support review and execution of study contracts and statements of work; Manage sample shipments and chain of custody documentation; Prepare and QC study documentation and regulatory submission materials; Update tracking dashboards and systems for project visibility; Facilitate transfer and archiving of nonclinical study data and final reports
