Director, Data Management Operational Excellence (Biotech)

Location: Cambridge, Massachusetts, United States; 70% in-office work model. Due to U.S. export control requirements, only U.S. persons are eligible for this position.

Salary: $167,000–$300,700 per year, with potential eligibility for a discretionary bonus, other incentive compensation, or equity award.

Company

hirify.global develops mRNA technology and medicines through a biotechnology and clinical development platform.

What you will do

• Design and continuously evolve the global Data Management and Clinical Data Standards operating model across therapeutic areas and development phases.
• Establish governance frameworks, standardized processes, decision rights, KPI systems, and portfolio-level performance analytics.
• Drive inspection readiness through audit-ready documentation, traceability controls, quality oversight, and regulatory inspection support.
• Oversee vendor governance, performance standards, risk escalation, and continuous improvement across outsourced operating models.
• Partner with Clinical Operations, Biometrics, Quality, Regulatory, and Digital functions to improve data flow, interoperability, and end-to-end data integrity.
• Lead process harmonization, automation, capacity planning, leadership development, succession planning, and operational risk mitigation.

Requirements

• Bachelor’s degree in life sciences, health sciences, data sciences, or a related analytical field; an advanced degree is preferred.
• 10+ years of progressive clinical data management experience in the pharmaceutical or biotechnology industry, including global Phase I–IV studies.
• Experience leading operational excellence, transformation, or large-scale process harmonization initiatives.
• Experience designing governance frameworks, KPI systems, performance analytics models, and vendor oversight strategies.
• Expert understanding of GxP requirements, including FDA regulations, ICH GCP guidelines, GCDM, Good Documentation Practices, and data integrity requirements.
• Must qualify as a U.S. person under U.S. export control laws; non-U.S. persons are not eligible for this position.

Nice to have

• Experience advancing digital innovation, automation, or analytics-driven process optimization in clinical development.
• Advanced degree in a relevant discipline.

Culture & Benefits

• 70/30 work model emphasizing in-office collaboration, teamwork, innovation, and mentorship.
• Healthcare coverage and voluntary benefit programs.
• Fitness, mindfulness, mental health, family planning, fertility, adoption, and surrogacy support.
• Paid vacation, volunteer days, sabbatical, global recharge days, and discretionary year-end shutdown.
• Savings and investment programs, plus location-specific benefits.