Our client is a clinical-stage biotechnology company seeking an accomplished and strategic Executive Director/Vice President, Head of Biometrics to lead and scale its biometrics organization during a critical phase of growth and late-stage clinical development.

This executive leader will be responsible for establishing and leading a high-performing Biometrics function encompassing Biostatistics, Statistical Programming, and Clinical Data Management. The successful candidate will serve as the senior biometrics leader within the organization, partnering closely with executive leadership to drive clinical development strategy, regulatory interactions, and organizational growth.

This role represents an opportunity to build and shape a modern biometrics organization while influencing pivotal clinical programs, regulatory submissions, and long-term development strategy.

Key Responsibilities

Executive Leadership & Functional Development

• Build, develop, and lead a world-class Biometrics organization including Biostatistics, Clinical Data Management, and Statistical Programming.
• Establish the vision, operating model, technology infrastructure, and quality standards necessary to support continued organizational growth.
• Serve as a key member of the Research & Development leadership team, contributing to portfolio strategy and enterprise-wide decision-making.
• Partner with executive leadership to align biometrics priorities with corporate objectives, development timelines, and resource planning.
• Drive innovation in biometrics processes, technology platforms, analytics capabilities, and operational efficiency.

Clinical Development & Regulatory Strategy

• Provide strategic leadership for the design, execution, analysis, and interpretation of early- and late-stage clinical trials.
• Guide statistical strategy across clinical development programs, including regulatory submissions and interactions with global health authorities.
• Ensure scientific rigor, regulatory compliance, and data integrity across all clinical studies and development activities.
• Oversee the development and review of protocols, statistical analysis plans, clinical study reports, integrated summaries, and regulatory submission documents.
• Evaluate and implement innovative clinical trial methodologies, adaptive designs, estimand frameworks, Bayesian approaches, and real-world evidence strategies where appropriate.

Cross-Functional Collaboration & Scientific Leadership

• Serve as a trusted advisor to Clinical Development, Regulatory Affairs, Drug Safety, Clinical Operations, Medical Affairs, Research, and Executive Leadership teams.
• Translate complex statistical concepts into clear, actionable insights for diverse audiences, including senior executives, boards of directors, and regulatory agencies.
• Drive data-driven decision-making across the organization and promote a culture of scientific excellence and analytical rigor.
• Contribute strategic input to development plans, portfolio prioritization, and commercialization readiness activities.

Vendor & CRO Oversight

• Provide executive oversight for CROs and external biometrics vendors.
• Lead vendor selection, contract negotiations, governance activities, and performance management.
• Ensure external partners consistently meet quality, compliance, timeline, and budget expectations.
• Establish strong vendor oversight frameworks supporting global development programs.

Qualifications

Required

• PhD in Biostatistics, Statistics, or related quantitative discipline.
• 12+ years of progressive pharmaceutical or biotechnology industry experience with increasing leadership responsibility.
• Demonstrated success leading Biometrics organizations supporting late-stage or pivotal clinical development programs.
• Significant experience supporting regulatory interactions and major global submissions, including FDA and/or EMA engagements.
• Deep expertise in clinical trial design, statistical methodology, adaptive trial designs, estimand frameworks, and regulatory requirements.
• Proven ability to build, mentor, and lead high-performing teams.
• Exceptional communication skills with the ability to effectively engage stakeholders ranging from technical experts to executive leadership.
• Strong business acumen and strategic leadership capabilities.
• Experience managing CROs and biometrics vendors supporting global clinical programs.

Preferred

• Experience supporting biologics, advanced therapeutics, cell and gene therapies, immunology, autoimmune diseases, oncology, or other complex therapeutic areas.
• Prior experience supporting BLA, NDA, or global regulatory submissions.
• Demonstrated success implementing innovative biometrics methodologies, technologies, or operating models.
• Experience scaling biometrics organizations within emerging biotechnology companies.

What Makes This Opportunity Unique

• Executive leadership role with direct influence on development strategy and organizational growth.
• Opportunity to build and shape a next-generation Biometrics organization.
• Significant exposure to executive leadership, board-level discussions, and regulatory interactions.
• High-impact role supporting pivotal-stage clinical programs and future regulatory submissions.
• Collaborative, science-driven culture with the opportunity to influence company-wide decision-making.
• Competitive compensation package including base salary, annual bonus, equity participation, and comprehensive benefits.