Director, Data Management Operational Excellence (Biotechnology)

Location: Cambridge, Massachusetts, United States. Hybrid 70/30 work model with 70% of work performed in the office. Only U.S. persons are eligible because of U.S. export control requirements.

Salary: $167,000–$300,700 per year, with potential eligibility for an annual discretionary bonus, additional incentive compensation, or equity.

Company

hirify.global develops mRNA-based therapeutics and vaccines using its mRNA science, delivery technology, and manufacturing 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, and KPI systems for portfolio-level performance and risk visibility.
• 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, digital enablement, automation, capacity planning, leadership development, and succession planning.

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 leadership of global Phase I–IV studies.
• Experience leading operational excellence, transformation, or large-scale process harmonization initiatives.
• Experience designing governance frameworks, KPI systems, portfolio-level performance analytics, and vendor performance governance.
• Strong leadership, executive communication, analytical thinking, and ability to influence senior stakeholders without direct authority.
• Expert understanding of global GxP requirements, FDA regulations, ICH GCP guidelines, clinical data standards, inspections, and audits.

Nice to have

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

Culture & Benefits

• In-office collaboration supported through a 70/30 working model.
• Healthcare and voluntary benefit programs.
• Fitness, mindfulness, mental health, and family planning support.
• Paid vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
• Savings and investment programs, plus location-specific benefits.