Senior Director, Biometrics

About the role

The reports directly to the VP of Clinical Development and holds significant influence over clinical development decisions for the company's gene therapy portfolio. In this capacity, the hire will own the definition and execution of biometrics strategy across all clinical programs, ensuring alignment with the broader clinical development objectives. They will establish study design frameworks, endpoint selection, and estimands logic in partnership with therapeutic area leaders and operational teams. This role requires building and maintaining the conditions for the biometrics and clinical data management teams to succeed through clear context, obstacle removal, and active coaching. The position is measured by the quality and timeliness of key statistical deliverables, team retention, and the successful execution of the pipeline strategy. Leaders in this role are expected to be highly visible, predictable, and generous with statistical context to cross-functional partners. Success is defined by the ability to translate complex regulatory and scientific requirements into actionable plans that advance program milestones efficiently.

Key facts

What you'll do

Define the overarching biometrics strategy for Prime Medicine's clinical programs, integrating biostatistics, data management, and statistical programming through vendor ecosystems.

Establish study design principles, endpoint selection logic, and estimands frameworks tailored to the complexities of early- and mid-stage gene therapy development.

Provide critical input into clinical trial design, including sample size and power calculations, randomization schemes, and the development of comprehensive statistical analysis plans.

Lead the creation, review, and approval of key statistical deliverables such as protocols, interim and final analyses, source data verification checks, and clinical study reports.

Champion the implementation and adherence to data standards, including CDISC and SDTM expectations, to ensure data quality, integrity, and inspection readiness across programs.

Lead vendor selection, onboarding, and governance activities for biometrics CROs and service providers, aligning scope, deliverables, timelines, budgets, and quality standards.

Actively manage vendor performance, timelines, budgets, and issue resolution, with direct oversight and timely escalation of biometrics deliverables to mitigate risk.

Provide leadership and guidance during regulatory interactions, supporting the preparation of IND and CTA submissions, health authority briefing packages, and responses to technical questions on study design and analyses.

Support inspection readiness and audits through the maintenance of clear processes, documentation, and evidence trails for biometrics operations.

Plan for longer term capacity needs as the pipeline evolves, developing team expansion strategies and capability models to meet future program demands.

Foster a culture of cross-functional collaboration, ensuring close alignment with clinical operations, medical affairs, and regulatory teams to achieve shared objectives.

Mentor and develop senior biometrics staff, providing career guidance and practical leadership that strengthens the overall function and prepares it for scaled growth.

Drive decision-making frameworks that balance scientific rigor with operational efficiency, ensuring that statistical considerations are embedded in program strategy from the outset.

Requirements

The posting states a pay range of $263000 to $292000.

The posting states a bachelor's degree requirement. An advanced degree in Statistics, Biostatistics, Mathematics, or a related quantitative field is required.

Demonstrated experience leading clinical trial design, statistical methodology, and regulatory submissions is required, ideally from early-phase through later stage programs.

Proven experience leading biometrics through CRO and vendor models is required.

Deep familiarity with FDA, EMA, and ICH regulatory expectations for biometrics is required.

Strong leadership, communication, and cross functional collaboration skills are required.

Practical notes

This role requires U.S. authorization to work.

The position is based in Cambridge, MA.

Typical interview steps

Leadership hiring usually includes a strategy case, a people scenario, and a values conversation. Candidates may be asked to turn around a struggling team or plan for growth. Past results are examined closely, especially how decisions were made. Interviewers dig into specific decisions you made and their consequences. Preparing two or three decision stories with numbers and lessons is the best use of time.

Good to know

The role centers on gene editing therapies and modern clinical trial design.

Statistical methods, data management, and vendor engagement define day to day work.

The team operates in a lean, fast moving biotech setting.

Regulatory standards for biometrics are emphasized across submissions and audits.

Mentoring and operational ownership support growth of the function.

Career growth

Leadership careers move from manager to senior manager, director, and executive roles. Each step adds more scope and more responsibility for outcomes. The best leaders keep learning how to delegate, communicate, and decide. Leadership careers reward a record of building and developing people. The higher you go, the more your communication shapes the whole organization.