Pioneering Medicines: Non-Clinical DMPK Operations Specialist (Senior Scientist Level) at Flagship Pioneering, Inc.
About the role Flagship Pioneering, Inc. is seeking a meticulous and proactive Non-Clinical DMPK Operations Specialist to bolster our drug discovery and development efforts. In this crucial role, you will be responsible for managing and coordinating nonclinical DMPK and toxicology studies, working closely with Contract Research Organizations (CROs), internal teams, and subject matter experts. Your primary goal will be to ensure operational excellence while adhering to established protocols, regulatory requirements, and Valuable Laboratory Practice (GLP) standards throughout the pharmacokinetics (PK), bioanalysis (BA), absorption, distribution, metabolism, and excretion (ADME), and toxicology studies.
Key facts
Location: Cambridge, MA, USA
Engagement: Contract, paid hourly
Team: Pioneering Medicines
What you'll do
Oversee the management of study proposals, budgets, and timelines specific to DMPK and toxicology operations.
Act as the main point of contact between internal teams, CROs, and subject matter experts to facilitate smooth collaboration.
Ensure that all toxicology studies are conducted in compliance with GLP standards.
Promote effective communication among all stakeholders involved in the studies.
Assist in the review and execution of study contracts and statements of work (SOWs) to ensure clarity and compliance.
Collaborate with legal, finance, and subject matter experts to negotiate new contracts and manage renewals.
Supervise the inventory of test articles,



sample tracking, and logistics for shipments to guarantee timely delivery.
Support Study Directors throughout the entire study lifecycle, from pre-study planning to data review and report archiving.
Monitor study milestones and maintain internal project databases for accurate status updates and financial forecasting.
Manage the logistics of sample shipments while ensuring proper chain of custody documentation is maintained.
Prepare and verify the quality of study documentation, data templates, and materials for regulatory submissions (IND, IB).
Regularly update tracking dashboards and systems to ensure visibility of project timelines and deliverables.
Maintain documentation that is audit-ready and compliant with internal Standard Operating Procedures (SOPs) and regulatory expectations.
Requirements
A Bachelor's degree in Life Sciences, Project Management, or a related discipline; an advanced degree is a plus.
At least 3 years of experience in nonclinical operations, DMPK, or toxicology support roles.
Foundational knowledge of PK, ADME, and toxicology study designs and execution processes.
Understanding of regulatory compliance and GLP guidelines is essential.




Proficiency in Microsoft Word, Excel, and electronic submission tools is required.
Strong organizational skills and effective communication abilities are necessary for success in this role.
Nice to have
Experience with project management software or tools.
Familiarity with data analysis and visualization tools.
Previous experience working in a contract research organization (CRO) environment.
Knowledge of pharmacokinetics and toxicology regulations.
Advanced degree in a relevant scientific field.
Skills & tools
Proficient in advanced Excel functionalities for data management and tracking purposes.
Ability to multitask effectively in a fast-paced, deadline-oriented environment.
Strong attention to detail with a commitment to maintaining high-quality standards in all aspects of work.
Capability to work both collaboratively as part of a team and independently when required.
Practical notes
The duration of the contract is flexible and will be determined based on project requirements, with an expected start date in June or July ****.
The hourly compensation for this position ranges from $52 to $85, with the contractor being employed through a third‐party staffing agency.
Certain employee benefits may be accessible through the staffing company after meeting minimum eligibility criteria.
Please note that the compensation and benefits information provided is based on the company's best estimate as of the publication date and may be subject to change in the future.
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📌 Pioneering Medicines: Non-Clinical Dmpk Operations Specialist (Senior Scientist Level) (Hobart)
🏢 Flagship Pioneering
📍 Hobart