Director, Clinical Monitoring Strategy and Oversight

Location: Cambridge, Massachusetts, with a 70/30 in-office work model. Due to U.S. export control requirements, only U.S. persons are eligible.

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

Company

hirify.global develops mRNA technology and medicines to transform how treatments are created and delivered.

What you will do

• Define and lead the global clinical monitoring strategy across clinical development programs, covering on-site, remote, centralized, and risk-based monitoring.
• Establish enterprise monitoring standards, governance, quality metrics, and oversight processes for internal teams and CRO partners.
• Drive risk-based monitoring through Critical to Quality factors, Key Risk Indicators, Quality Tolerance Limits, analytics, and monitoring dashboards.
• Lead CRO performance oversight, escalation, issue resolution, and optimization of monitoring delivery models.
• Modernize monitoring through digital health technologies, AI-enabled analytics, automation, and emerging regulatory approaches.
• Build and develop internal clinical monitor teams, training frameworks, competencies, and continuous improvement practices.

Requirements

• Bachelor’s degree in Life Sciences, Healthcare, Nursing, Pharmacy, or a related field, or equivalent experience; an advanced degree is preferred.
• At least 13 years of experience in clinical research, clinical operations, clinical quality, or a related function, including leadership of clinical monitoring strategy and oversight in global trials.
• Deep knowledge of ICH GCP, ICH E6(R3), ICH E8(R1), and global regulatory expectations for risk-based monitoring and clinical trial oversight.
• Expertise in risk-based, centralized, and remote monitoring, CRO oversight, clinical analytics, RBQM platforms, monitoring technologies, and data visualization.
• Demonstrated ability to influence senior stakeholders and lead complex cross-functional initiatives in a global matrix organization.
• Ability to travel up to 25% and meet U.S. person eligibility requirements for access to export-controlled information.

Culture & Benefits

• In-person collaboration supported through a 70/30 in-office work model.
• Healthcare and voluntary benefit programs, plus fitness, mindfulness, and mental health resources.
• Family planning support, including fertility, adoption, and surrogacy benefits.
• Paid time off including vacation, volunteer days, sabbatical, global recharge days, and year-end shutdown.
• Savings and investment programs, with location-specific perks and extras.