Associate Director, Clinical Operations Study Lead (Clinical Trials)

Location: Waltham, Massachusetts, United States; onsite. The role requires up to 20% travel, including international travel.

Salary: $165,000–$200,000 USD per year

Company

hirify.global develops therapeutics targeting muscle and the central nervous system for genetically driven neuromuscular diseases, including Duchenne muscular dystrophy and myotonic dystrophy type 1.

What you will do

• Lead clinical studies from start-up through close-out, ensuring delivery against timelines, milestones, budgets, quality standards, SOPs, ICH GCP, and applicable regulations.
• Develop study-level operational strategies and plans aligned with clinical development programs.
• Select, oversee, and manage CROs and other vendors, including performance metrics, risks, protocol deviations, quality events, CAPAs, and sponsor oversight.
• Lead cross-functional study teams, investigator meetings, site engagement, patient enrollment strategies, and proactive data monitoring.
• Manage study budgets, invoices, forecasting, operational reports, and risk mitigation plans.
• Review clinical and regulatory documents, maintain an inspection-ready TMF, and contribute to process improvement and operational best practices.

Requirements

• Undergraduate degree in a scientific or health-related discipline; an advanced scientific or business degree is desirable.
• 8+ years of clinical trial management experience across global Phase I–III studies, preferably with both a sponsor company and CRO.
• Experience managing outsourced clinical trials, vendors, study budgets, accruals, forecasting, timelines, and quality requirements.
• Strong understanding of drug development, ICH guidelines, GCP, clinical trial processes, and US/EU patient data privacy laws.
• Ability to lead teams in a fast-paced matrixed environment, prioritize multiple activities, solve complex problems, and collaborate across clinical operations, Medical Affairs, Commercial, CROs, and vendors.
• Ability and willingness to work onsite in Waltham, Massachusetts and travel up to 20%, including internationally.

Nice to have

• Experience in neuromuscular, muscle, rare disease, or pediatric clinical trials.
• Prior site or clinical monitoring experience.
• Experience building relationships with key opinion leaders and clinical site personnel.
• Advanced scientific or business degree.

Culture & Benefits

• Opportunity to contribute to clinical programs for genetically driven neuromuscular diseases.
• Work with cross-functional and external clinical operations teams in a matrixed environment.
• Responsibility for coaching and developing indirect reports supporting clinical trials.
• Equal opportunity employment environment.