Pioneering Medicines: Non-Clinical Operations Specialist

Responsibilities

• CRO and Stakeholder Liaison
• Coordinate study proposals, budgets, and timelines across DMPK (PK, BA, ADME, immunogenicity) and toxicology functions.
• Act as the primary point of contact between internal teams, CROs, and SME consultants.
• Ensure the smooth execution of toxicology studies, maintaining GLP compliance and regulatory standards.
• Facilitate transparent and timely communication across stakeholders.
• Contract and Logistics Management
• Support review and execution of study contracts and statements of work (SOWs).
• Partner with legal, finance, and SME consultants for new contracts and renewals.
• Oversee test article inventory, sample tracking, and CRO shipment logistics to ensure timely delivery.
• Study and Project Support
• Assist Study Directors from pre-study planning to data review and report archiving.
• Track study milestones and maintain internal project databases for status updates and financial planning.
• Manage sample shipments and chain of custody documentation.
• Prepare and QC study documentation, data templates, and regulatory submission materials (IND, IB).
• Maintain and improve study outline templates and shipping/data tracking tools (advanced Excel skills required).
• Data and Compliance Oversight
• Update tracking dashboards and systems to ensure visibility of project timelines and deliverables.
• Facilitate the transfer, archiving, and database upload of nonclinical study data and final reports.
• Ensure documentation is audit-ready and aligned with internal SOPs and regulatory expectations.

Requirements

• Bachelor's degree in Life Sciences, Project Management, or related field (advanced degree a plus).
• 3+ years of experience in nonclinical operations, DMPK, or toxicology support roles.
• Basic understanding of PK, ADME, and toxicology study designs and execution.
• Familiarity with regulatory compliance and GLP guidelines.
• Proficient in Microsoft Word, Excel, and electronic submission tools.
• Strong organizational and communication skills.
• Additional Attributes
• Meticulous attention to detail and a commitment to quality.
• Skilled multitasker who thrives in dynamic, deadline-driven environments.
• Proactive, collaborative team player who also works independently.
• Passionate about enabling scientific discovery through operational excellence.
• Contract Duration: Flexible based on project needs
• Start Date: June or July 2026
• About Flagship
• Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, "FSP") do not accept unsolicited resumes from any source other than candidates. The su

Benefits

Additional Information

Job Title: Nonclinical Operational Specialist - Contractor Location: Hybrid Job Type: Contract Position Summary We are seeking a detail-oriented and proactive DMPK/Nonclinical Operational Specialist to support our drug discovery and development programs. In this critical role, you will manage and coordinate nonclinical DMPK and toxicology studies by liaising with Contract Research Organizations (CROs), internal teams, and subject matter experts. You will ensure operational excellence and compliance throughout the execution of pharmacokinetics (PK), bioanalysis (BA), ADME, and toxicology studies, aligning with protocols, regulations, and GLP standards.

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