Position Overview:

Join a collaborative, agile and dynamic Clinical Development Operations (CDO) team by leading and contributing to transformative clinical programs for patients in rare diseases and beyond.

In this position, you will be hands-on in day-to-day study execution, working closely with internal study team members, clinical sites, and external CROs and vendors. This position is ideal for someone who thrives in a fast-paced, evolving environment, is comfortable wearing multiple hats, and is eager to learn more about clinical trial management and execution. This is a hybrid role requiring a combination of in-office presence (Watertown, MA) and remote work, with expectations aligned to team and business needs.

Key Responsibilities:

· Support the execution of clinical trials from startup through closeout, ensuring adherence to protocol, timelines, and quality standards

· Assist with site startup activities, including regulatory document collection, IRB/EC submissions, and site readiness/activation

· Support development of study and site-facing materials (e.g., ICFs, recruitment materials, study manuals, CCGs, study tools) and coordinate cross-functional review and approval

· Prepare and maintain meeting minutes, action items, and follow-ups for key study team meetings

· Maintain study documentation (e.g., sponsor TMF oversight and ISF support) to ensure completeness, quality, and inspection readiness

· Oversee CRO/vendor TMF activities, ensuring alignment with sponsor expectations, TMF plans, and filing timelines

· Track study progress, enrollment, IRB/EC submissions and queries, and key operational metrics; proactively identify and escalate risks to timelines or deliverables

· Serve as a primary point of contact for CRAs and sites to address day-to-day operational questions and issues

· Track and monitor key subject visits and study milestones to ensure protocol compliance and data integrity

· Support inspection readiness activities, including TMF reviews, audit support, and resolution of findings

· Support clinical sample management activities, including coordination of central labs, sample logistics, tracking, and issue resolution

· Review clinical data, monitoring reports, and protocol deviations to ensure quality, compliance, and timely issue resolution

· Contribute to SOP development, process improvements, and operational best practices within a growing organization

Qualifications:

· BS/BA/RN Degree in science or a health-related field is preferred

· Minimum 2–4 years of clinical research experience; sponsor experience is strongly preferred.

· Familiarity with clinical trial operations, ICH-GCP, and regulatory requirements

· Experience and understanding of EDC systems, TMF systems, and clinical trial documentation

· Familiarity with clinical data review and data management processes, including Data Monitoring Committees

· Highly organized with strong attention to detail

· Ability to manage multiple priorities with a sense of urgency in a fast-paced environment

· Strong communication and relationship-building skills

· Resourceful, proactive problem-solver with a “do-what-it-takes” mindset

· Comfortable operating in a dynamic environment with evolving processes and priorities

· Self-motivated, collaborative, and able to work both independently and cross-functionally

· Positive, team-oriented attitude with a passion for advancing innovative therapies for patients

· Excitement to contribute to Prime Medicine’s culture!

Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability, protected veteran status, or any other characteristic protected by law.

Position Overview

We are seeking an enthusiastic, self-motivated Senior Scientist to join the Nonclinical Development group, supporting the nonclinical safety assessment function for IND-enabling programs across Prime Medicine’s pipeline. Reporting to the Associate Director, Safety Assessment, the successful candidate will support the design, execution, and interpretation of nonclinical safety studies conducted both in-house and at CROs, with an initial focus on liver-targeted therapeutics. This role requires hands-on involvement in assay execution and troubleshooting, as well as active participation in study oversight of work being done at CRO and data analysis.

This role requires collaboration within cross-functional teams. The ideal candidate will hold a Ph.D. in toxicology or a related field with 6+ years of pharma/biotech experience in nonclinical safety assessment, or an M.S. in toxicology or a related field with 10+ years of experience in nonclinical safety assessment, the ability to work independently, provide domain expertise and leadership, as well as cross-functionally in a fast-paced, matrixed environment with a positive, flexible attitude.   

Primary Responsibilities

• Contribute to nonclinical safety activities as part of cross-functional Discovery and Development project teams, supporting program progression through IND-enabling stages.
• Design, execute, and troubleshoot nonclinical safety studies, including hands-on laboratory work (~30%) to support assay development, data generation, and issue resolution.
• Support the execution and oversight of nonclinical safety studies (GLP and non-GLP) at CROs, including active involvement in troubleshooting assay and study-related challenges.
• Analyze and interpret study data with guidance and contribute to the preparation of study reports and supporting documents for regulatory submissions.
• Collaborate with Pharmacology, DMPK, and other functions to support exploratory studies (e.g., exploratory toxicology, DMPK, biodistribution, and delivery platform evaluation).
• Contribute to evaluation of new delivery approaches, Lipid and RNA components, and emerging targets to support pipeline expansion.
• Assist in identifying potential safety findings and contribute to discussions on data interpretation and next steps.
• Ensure studies and internal activities are conducted in compliance with regulatory guidelines and internal standards.

Preferred Qualifications

• Ph.D. in toxicology or a related discipline with 6+ years of biopharmaceutical industry experience, or M.S. in toxicology or a related field with 10+ years of relevant biopharmaceutical industry experience supporting drug development in nonclinical safety/toxicology.
• Experience in large molecule therapeutic development, along with a background in immunology, is desirable.
• Understanding of toxicology principles, nonclinical safety evaluation, and the drug development process, with some experience interpreting toxicology data and contributing to technical and scientific reports.
• Demonstrates strong scientific judgment and leadership with the ability to evaluate information, identify potential issues, and propose practical solutions with guidance as needed.
• Highly organized and detail-oriented with strong attention to accuracy and quality.
• Strong communication and collaboration skills, with the ability to work effectively across multidisciplinary teams and with external partners.
• Experience supporting nonclinical studies at CROs is preferred but not required.

Role Summary

Prime Medicine is seeking an AI & Informatics Engineer to join our AI Foundry and support our pipeline delivery.  This includes designing and building the data and computational infrastructure that powers our prime editing programs. This role spans laboratory informatics, NGS pipeline development, and AI-enabled tooling, giving the right candidate a direct line from the work they do to the therapies we develop. You will partner closely with research scientists, computational biologists and technical development professionals, turning raw data into reliable scientific insights, and building automation and AI capabilities that let teams work faster and smarter.

Our ideal candidate brings strong software engineering fundamentals, hands-on NGS pipeline experience, a practical understanding of modern AI frameworks, and the biological intuition to translate scientific needs into working systems. Equally welcome are candidates who entered this space from the life sciences side and have built serious software skills along the way.

This is an action packed and dynamic role where the successful candidate will be involved in multiple programs and activities, so excellent organizational abilities, communications and strong collaboration are critical. The ideal candidate thrives when working in a fast-paced environment, working with purpose, and making an impact for patients.

Key Responsibilities

NGS Pipelines and Data Infrastructure

• Design, develop, and maintain scalable bioinformatics pipelines for NGS data analysis, including amplicon sequencing for on-target editing quantification, using Nextflow and Docker to ensure reproducibility.
• Build and maintain data infrastructure connecting NGS instruments, electronic laboratory notebooks (e.g., Benchling), data repositories, and AWS cloud compute, including automated data ingestion, scalable storage, and provenance tracking.
• Build APIs, MCPs, dashboards, and other internal tools that expose genomic data and analytical capabilities to scientific and cross-functional teams.

Laboratory Informatics

• Support implementation and ongoing development of laboratory informatics systems, including data ingestion from key instruments and integration with laboratory data platforms such as Benchling.
• Support vendor relationships and delivery outcomes for external collaborators, driving requirements, managing implementations, and ensuring high-quality delivery.

AI-Powered Tools and Automation

• Build AI-powered and agentic capabilities that automate routine work, support scientific reasoning, and improve how data and knowledge flow across the organization.
• Develop reusable platform components for retrieval, orchestration, and model interaction, with human-in-the-loop workflows that make AI systems transparent and practical for scientific users.
• Identify and address automation opportunities and scalability bottlenecks across research and operational workflows.

Engineering Practices

• Write production-grade code using Git-based workflows, peer review, testing, CI/CD, and documentation best practices; convert research prototypes into robust, maintainable software.
• Build integrations between internal tooling and third-party platforms to support evolving scientific and operational needs.
• Participate in cross-functional projects spanning lab operations, software engineering, and bioinformatics; recommend best practices, system architectures, and design patterns.
• Perform code reviews and contribute to documentation of engineering and cross-functional practices.

Qualifications

Required

• BS with 5+ years or MS with 3+ years of industry experience in Engineering, Bioinformatics, Data Sciences, or a related field. Candidates with biotech or life sciences with substantial software experience are strongly preferred.
• Strong Python development; proficiency with Nextflow (or comparable workflow tools), Docker, AWS, Linux/Unix, and Git.
• Experience developing and deploying bioinformatic data infrastructure, particularly NGS analysis pipelines.
• Experience implementing or integrating laboratory informatics systems, preferably including Benchling.
• Experience developing and maintaining production-grade APIs and SDKs, and rolling out software tooling across an organization.
• Familiarity with LLM frameworks and practical judgment about where agentic approaches add genuine value.
• Track record of shipping software that scientific or technical users adopt and rely on.

Preferred

• Experience building and deploying AI-powered tools or agentic systems in production or research settings.
• Familiarity with gene editing applications (CRISPR, base editing, or prime editing), including amplicon-seq workflows and tools such as CRISPResso.
• Familiarity with relational databases and data visualization tools (e.g., Plotly Dash, Streamlit, Spotfire).
• Experience in a GxP or regulated software environment (21 CFR Part 11, GAMP 5).
• Experience owning vendor relationships and delivery outcomes for external collaborators in laboratory informatics contexts.

Why This Role

Prime editing is a precise technology, and that precision depends on strong informatics, software, and scientific infrastructure. If you believe that better systems, better automation, and better access to data can translate into safer and more effective therapies, this is the right environment. You will build tools that directly shape how Prime generates, analyzes, and acts on scientific data, while helping lay the foundation for programs to come.

Director, People and Culture Business Partner

Location: Cambridge and Watertown, MA (between two sites at least 3 days a week)

Reports To: VP, Senior People and Culture Business Partner

Who We Are

At Prime Medicine, we're not just editing genes — we're rewriting what's possible for patients living with debilitating genetic diseases. Built on the groundbreaking Prime Editing platform, a next-generation "search and replace" technology, we are on a mission to deliver potentially curative therapies to patients who have waited long enough.

Our team of scientists, engineers, and operators is intensely curious, deeply collaborative, and united by a shared belief: that the right science, paired with the right people, can change the course of disease. We move fast, think boldly, and take our work seriously — while making sure we enjoy the journey together.

This is a pivotal moment for Prime Medicine. We are focused, energized, and building toward breakthroughs that matter. If you want to do the most meaningful work of your career alongside people who feel the same, you've found your place.

The Opportunity

Prime Medicine is seeking a Director, People and Culture Business Partner — a passionate, people-first HR professional who is as comfortable shaping culture as they are rolling up their sleeves on the operational fundamentals that keep a growing biotech humming.

Reporting to the VP, Senior People and Culture Business Partner, you'll be a trusted partner to Prime's management and employees alike - someone who connects deeply with the business, champions our culture, and helps ensure our people strategy keeps pace with our science. At Prime, People & Culture is a strategic driver of our mission.

This role is for someone who works hard, has fun, and genuinely believes that great organizations are built one person, one team, and one conversation at a time.

What You'll Do

Be a Culture Champion

• Show up as the heart of our employee experience — approachable, credible, and genuinely invested in the people you work with.
• Partner with managers and employees to reinforce and evolve Prime's culture and values as the company grows.
• Support employee engagement initiatives and translate listening efforts (surveys, conversations, data) into meaningful action.
• Help to continue to make Prime the kind of place where brilliant people do their best, most fulfilling work.

Drive Talent Strategy

• Identify development opportunities that deepen our talent bench and build organizational capability for the long term.
• Support creative career pathing efforts and employee development programs that reflect Prime's startup spirit and scientific ambition.
• Serve as a true Talent Ambassador — someone employees, management, external vendors and candidates are excited to engage with.

Partner Strategically with the Business

• Partner closely with management to drive organizational effectiveness, workforce planning, and thoughtful change management.
• Translate Prime's evolving business priorities and values into people strategies that create real impact.
• Lead organizational design efforts and guide teams through change with clarity and care.
• Provide counsel that's both candid and compassionate on employee relations and management challenges.

Execute with Excellence

• Ensure flawless execution of core HR cycles: administration, compensation planning, promotions, talent mobility, headcount planning, recruitment, and workforce planning.
• Partner with Total Rewards to navigate compensation cycles effectively and equitably.
• Contribute to policy development and evolving compliance needs as Prime scales — with a pragmatic, startup-savvy lens.

What You Bring

• An advanced degree in Human Resources, Business, Life Sciences, or a related field.
• 10–12+ years of progressive HR experience, with significant HRBP experience supporting managers and employees.
• Deep experience in biotechnology, pharmaceuticals, or life sciences — you understand the cadence, culture, and complexity of science-driven organizations.
• A startup mentality with an operator's mindset: you know when to build from scratch, when to borrow a best practice, and when to just get it done.
• Demonstrated success juggling multiple priorities in a fast-moving environment without losing sight of the details or the people.
• Strong business acumen and executive presence — you influence at all levels, and people trust your judgment.
• A high tolerance for ambiguity, a bias toward action, and a track record of driving measurable outcomes.
• You work hard, have fun, and make the team around you better.

Why Prime Medicine

• Mission that matters: Every program we advance has the potential to change — or save — a life. You'll feel that every day.
• A team you'll love: brilliant, humble, fun people who take the science seriously
• A pivotal moment: Prime is a focused, forward-moving company with a clear path and bold ambitions. You'll help shape what comes next.
• Cambridge at its best: Sit at the epicenter of the world's most dynamic biotech ecosystem.
• A seat at the table: People and Culture is a strategic partner here. Your voice will be heard and your impact will be real.

Prime Medicine is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment where all employees can thrive.

Position Overview

We are seeking a motivated and skilled Senior Scientist to join the Nonclinical Development group, contributing to the DMPK function in support of exploratory and IND-enabling programs across Prime Medicine’s pipeline. Reporting to the Associate Director, DMPK/Bioanalytical Sciences, this individual will independently analyze and interpret datasets from in vivo studies, contribute to nonclinical regulatory documents, and work cross-functionally with pharmacology, translational biology and external CROs, to ensure high-quality DMPK data packages are delivered to support program timelines. The ideal candidate has a strong foundation in in vivo pharmacokinetics for RNA therapeutics and/or LNP-based delivery systems, thrives in a fast-paced and matrixed organization, and possesses the flexibility and positive attitude needed to make meaningful contributions to the Nonclinical Development team.

Primary Responsibilities

• Analyze and interpret PK study data from exploratory and IND-enabling in vivo
• Perform non-compartmental analysis (NCA) using Phoenix WinNonlin to derive key PK parameters (Cmax, AUC, T½, Vd, CL).
• Leverage expertise in DMPK to provide recommendations for in vivo study designs in collaboration with pharmacology and key stakeholders.
• Perform bioanalytical assay development (30%) and collaborate with bioanalytical scientists to trouble-shoot challenges during method development to ensure quantitative methods for key analytes (LNP lipid components, mRNA, pegRNA, PD biomarkers) meet regulatory expectations and data quality standards..
• Contribute to nonclinical regulatory documents including pharmacokinetics summaries and nonclinical study reports under the guidance of senior stakeholders in Nonclinical Development.
• Maintain thorough records in the electronic laboratory notebook (ELN); prepare clear data summaries, presentations, and technical memos for program team and governance meetings.

Qualifications

Minimum Qualifications

• D. in pharmacokinetics, pharmaceutical sciences, pharmacology, biochemistry, or a related discipline.
• 6+ years of cumulative experience. Industry experience (biotech or pharmaceutical) with direct responsibility for in vivo DMPK study design, execution, and interpretation is required; postdoctoral training in a DMPK or translational pharmacology setting is strongly preferred
• Demonstrated experience with in vivo PK studies in preclinical models and proficiency in NCA using Phoenix WinNonlin or equivalent software.
• Familiarity with regulatory expectations for nonclinical DMPK assessments and bioanalytical assay development.
• Demonstrated ability to coordinate with external CROs, including scientific guidance, protocol development, and data review..
• Strong written and verbal communication skills; ability to present complex DMPK data clearly to multidisciplinary audiences.
• Highly self-motivated, collaborative, and organized, with the ability to manage multiple priorities independently in a fast-paced matrix environment.

Preferred Qualifications

• Familiarity with PK/PD modeling concepts; experience with Phoenix WinNonlin modeling modules a plus.
• Experience with LNP-based delivery systems and/or RNA therapeutics (mRNA, siRNA, ASO, sgRNA or related modalities).
• Experience with exploratory DMPK studies, evaluating new delivery vehicles and evaluation of biodistribution using in vivo
• Familiarity with bioanalytical platforms supporting DMPK studies, including LC-MS/MS, RT-qPCR/ddPCR, ELISA/MSD.
• Ability and excitement to contribute to the development and success of the Nonclinical Development team.

Prime Medicine was founded to bring the promise of gene editing to patients. We use Prime Editing, a next-generation technology that can “search and replace” to restore normal genetic function almost anywhere in the genome. Prime Editing searches to find the precise place in the genome to edit and replaces the segment of faulty DNA with a correct copy of DNA.  A single Prime Editor can correct the individual mutations found across patients, meaning Prime Editing can potentially address more than 90 percent of known disease-causing genetic mutations. 

We envision a world where this technology can cure, halt, and ultimately prevent genetic diseases, providing lifelong benefit to patients.  Prime Medicine offers the opportunity to shape the future of gene editing and transform how medicines are used to treat disease. Realizing the promise of Prime Editing requires a talented team with diversity of viewpoints and expertise. We’re building a group of dedicated, scientifically curious individuals who are passionate about helping patients live longer, healthier lives.

Position Overview

Prime Medicine is seeking a talented and motivated Sr. Manager to join the Analytical Development & QC team within Technology, Development & Operations. This role will focus on Quality Control (QC) related activities for all programs, including management and technical oversight of tech transfer, qualification/validation and release and stability testing carried out at both CDMOs, CTLs and internally at Prime for our prime editing ex vivo cell therapy and in vivo LNP-based drug products.

The successful candidate will have deep understanding of method lifecycle management, including method optimization, qualification, validation/verification, transfer, and implementation in a cGMP environment, as well as previous hands-on experience in at least some aspects of the above. This is a role requiring strong cross-functional collaboration with Analytical Development, Quality, Process Development, Formulation, Informatics, and external partners (CTLs/CDMOs). 

The ideal candidate thrives in a matrixed, fast-paced environment, works effectively with limited supervision, and demonstrates strong technical ownership and execution.

Key Responsibilities

• Design or review analytical procedures and protocols supporting method lifecycle activities, including optimization, qualification, validation, transfer, verification, performance monitoring, bridging, and comparability studies
• Manage and conduct select release, stability, and in-process testing for drug substances, drug products, and gene-editing components, and carry out data analysis and trending
• Support and/or manage analytical method transfer to CTLs/CDMOs, providing oversight, troubleshooting, and ensuring technical and timeline objectives are met
• Manage GMP sample inventory and chain-of-custody documentation
• Lead, manage and maintain well-designed stability programs and reference standard programs
• Author and review protocols, reports, SOPs, and analytical sections of regulatory submissions
• Familiarity with and ability to learn and use new tools for productivity, project management, documentation, tracking scheduling, and data management.
• Support IQ/OQ/PQ of QC equipment and ensure compliance with 21 CFR Part 11
• Maintain GxP-compliant electronic documentation and thorough laboratory records
• Collaborate with Quality to ensure data integrity, regulatory compliance, and audit readiness
• Lead or support investigations, deviations, and root-cause analyses
• Present data and findings to cross-functional teams
• Prepare technical reports and documents for global regulatory submissions

Qualifications

Education & Experience

• BS/MS/PhD in Biochemistry, Molecular biology, Chemistry, Bioengineering, or a related discipline
• Industry experience:
• BS: 10+ years
• MS: 8+ years
• PhD: 3+ years

Technical Expertise

• Experience with analytical method optimization, tech-transfer, qualification, validation, and verification used for critical components, drug substance and drug product release and stability testing
• Hands-on experience with analytical methodologies such as:
• Chromatography-based assays
• Absorbance-based assays
• Cell-based assays
• Compendial assays
• Molecular-based assays
• Flow cytometry assays
• Familiarity with ICH and FDA guidelines for CMC development during clinical stage is required
• Experience in advanced cell and gene-editing therapeutics development is not mandatory, but highly desirable
• Experience working with CMOs/CDMOs is required
• Experience with stability and/or reference standard programs is a plus
• Knowledge of assays, instrumentation, and facility qualification/validation requirements is desirable
• Familiarity with regulatory writing

Personal Attributes

• Highly self-motivated with strong project ownership
• Strong collaborator with internal cross-functional and external partners
• Adaptable in a dynamic, fast-paced environment
• Detail-oriented with strong troubleshooting and problem-solving skills
• Excellent written and verbal communication skills
• Strong abilities to lead and facilitate technical meetings with CDMO and CTL SMEs
• Work with purpose and drive meaningful results
• Ability to innovate and challenge industry status quo
• Ability to travel for up to 5 - 10% of the time

Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability, protected veteran status, or any other characteristic protected by law.

Position Summary

The Staff Accountant will play a key role in the accounting and financial activities for Prime Medicine.  In this crucial role, the Staff Accountant will have exposure to a wide range of business and operational initiatives, accounting and financial reporting activities and ad hoc projects.

This role is focused on monthly and quarterly close financial procedures and supports the Procure-to-Pay functions.  The candidate will join an evolving finance and accounting team recognized as valued business partners. This position offers exposure to many levels of the organization, providing outstanding opportunities to influence the direction of the business and to grow your career.

Position will report directly to Associate Director of Procurement.   

Key Responsibilities

• Execute month-end, quarter-end, and year-end close activities in a timely and accurate manner, including preparation and posting of journal entries, account reconciliations, roll forwards and variance analyses
• Provide internal customer service support for the Procure-to-Pay (P2P) processes and day-to-day activities, ensuring users are properly trained and transactions are recorded accurately
• Maintain Vendor Master File and act as the primary contact for vendor inquiries regarding payment status and statement reconciliation
• Lead efforts around accounts payable efficiencies, including driving automation and other process enhancements
• Manage weekly cash disbursement processes, coordinate payment approvals and payment timing
• Oversee and manage Concur for employee expense reports from review to reimbursement, ensuring compliance with company policies
• Manage fixed assets and depreciation ensuring compliance with accounting standards and company policies

• Support external and internal audits by preparing schedules, reconciliations, and documentation
• Ensure business transactions continue to be in accordance with generally accepted accounting principles, policies, and SOX controls

• Assist with special projects and ad-hoc analysis across accounting functions as assigned

Education & Experience

• Bachelor’s degree in finance or accounting (preferred), with 2-3 years of progressive accounting experience with at least 2 years in public accounting or a high-growth tech/life sciences company

• Strong understanding of U.S. GAAP and willingness to deepen technical accounting knowledge
• Proficiency in MS Office (especially Excel) and experience with accounting/ERP software

Required Skills & Competencies

• Demonstrated analytical skills to solve complex problems and address a variety of variables in situations with limited standardization
• Strong organizational skills to effectively balance priorities, handle workload, and complete projects on time
• Highly organized and diligent, with time management abilities
• Strong interpersonal skills for effectively communicating with internal & external stakeholders of all levels.
• Ability to work independently across multiple financial systems and troubleshoot/resolve issues as needed.
• Self-motivated and capable of working independently
• Hybrid work position with some in-person attendance required (Cambridge, MA)