Pioneering Medicines: Non-Clinical Operations Specialist - #305641

Job Title: Nonclinical Operational Specialist – Contractor

Location: Hybrid

Job Type: Contract, paid hourly

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.

Key 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.

Qualifications

• 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

Flagship Pioneering is a scientific innovation engine that invents and builds companies that change the world. 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.

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. Our team of scientists, entrepreneurial leaders, and professional capital managers are each aligned around an institutionalized process that enables us to innovate and create breakthroughs for the benefit of people and planet. Many of the companies Flagship has founded have addressed humanity's most urgent challenges: 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.

Flagship has been recognized twice on FORTUNE's "Change the World" list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies, and has been named four times to Fast Company's annual list of the World's Most Innovative Companies.

At Flagship, we recognize there is no perfect candidate. 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. We are dedicated to building diverse and inclusive teams and look forward to learning more about your unique background.

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 submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.

Privacy Notice for Applicants: When you apply for a role at Flagship Pioneering or one of its portfolio companies, we collect and use personal information you provide (such as your name, contact details, work history, and application materials) to evaluate your application, communicate with you, and comply with legal obligations. Your application data is processed through Greenhouse, our applicant tracking system, and may also be reviewed using AI-assisted screening tools. We do not sell your personal information. California residents have rights under the CCPA/CPRA including to know, delete, and opt out of the sharing of their personal information. If you are located in the EU or UK, we process your data under GDPR and you have rights to access, rectify, and erase your data. To exercise your rights or for questions, contact [email protected].

The pay range for this role is $52 - $85 per hour and the contractor will be employed by a third-party staffing company. Certain employee benefits may be available to the contractor through the staffing company after meeting minimum criteria. 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

Privacy Notice for Applicants: When you apply for a role at Flagship Pioneering or one of its portfolio companies, we collect and use personal information you provide (such as your name, contact details, work history, and application materials) to evaluate your application, communicate with you, and comply with legal obligations. Your application data is processed through Greenhouse, our applicant tracking system, and may also be reviewed using AI-assisted screening tools. We do not sell your personal information. California residents have rights under the CCPA/CPRA including to know, delete, and opt out of the sharing of their personal information. If you are located in the EU or UK, we process your data under GDPR and you have rights to access, rectify, and erase your data. To exercise your rights or for questions, contact [email protected].