Flagshippioneeringinc

Pioneering Medicines: Non-Clinical DMPK Operations Specialist (Senior Scientist Level)

Cambridge, MA USA · Senior · Contract

Sponsorship not specified$52k-$85kDetected 7 days ago

ComplianceProject ManagementExcelLogisticsRecruitingResearchCommunicationMicrosoft Office

About the role

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.

Support review and execution of study contracts and statements of work (SOWs).
Partner with legal, finance, and SME consultants for new contracts and renewals.
Study and Project Support
Track study milestones and maintain internal project databases for status updates and financial planning.
Manage sample shipments and chain of custody documentation.
Flagship Pioneering is a scientific innovation engine that invents and builds companies that change the world.

3+ years of experience in nonclinical operations, DMPK, or toxicology support roles.
Familiarity with regulatory compliance and GLP guidelines.
What sets Flagship apart is our ability to advance biotechnology by uniting life science innovation, company creation, and capital investment under one roof in a way that is largely without precedent.
If you have some of the experience listed above but not all, please apply anyway.
Experience comes in many forms, skills are transferable, and passion goes a long way.
Bachelor's degree in Life Sciences, Project Management, or related field (advanced degree a plus).
Basic understanding of PK, ADME, and toxicology study designs and execution.
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

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.
Oversee test article inventory, sample tracking, and CRO shipment logistics to ensure timely delivery.
Assist Study Directors from pre-study planning to data review and report archiving.
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).

The pay range for this role is $52 - $85 per hour and the contractor will be employed by a third-party staffing company.
Compensation and benefits information is based on Pioneering Medicines's good faith estimate as of the date of publication and may be modified in the future.

We bring together the greatest scientific minds with entrepreneurial company builders and assemble the capital to allow them to take courageous leaps in human health, sustainability, and beyond.
vaccinating billions of people against COVID-19, curing intractable diseases, improving human health, preempting illness, and feeding the world by improving the resiliency and sustainability of agriculture.

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This listing is sourced directly from Flagshippioneeringinc's careers page and normalized into a canonical job model.