Sr. Director, Clinical Operations Capabilities and Standards

TL;DR

Sr. Director, Clinical Operations Capabilities and Standards: Provide strategic leadership and oversight for centralized trial operations support to enable cost-effective scalability of Clinical Operations, with an accent on building and governing clinical operations capability pillars (planning & analytics, operational technologies, vendor alliance management, site contracts & payments, and sample & imaging management). Focus on serving as the portfolio-level clinical operations standards subject-matter expert and ensuring inspection-ready, compliant execution across global clinical development programs.

Location: Somerset, New Jersey, United States

Salary: $222,672 - $292,258 USD (base pay)

Company

hirify.global is a global biotechnology company developing advanced cell therapies and immunotherapies for life-threatening diseases.

What you will do

• Establish, oversee, and grow Clinical Operations capability pillars, including Clinical Trial Planning & Analytics, Clinical Trial Operational Technologies, Vendor Alliance Management, Site Contracts & Payments, and Sample & Imaging Management Operations.
• Provide end-to-end leadership for clinical trial feasibility and predictive trial performance modeling to support protocol optimization, country/site selection, enrollment forecasting, and risk mitigation.
• Own and govern clinical trial operations systems (e.g., CTMS and eTMF) to ensure compliant, efficient, inspection-ready execution and technology-enabled risk management.
• Lead vendor alliance governance, performance management via objective metrics, issue escalation, and continuous improvement across CROs and external clinical operations vendors.
• Oversee scalable operating models for site contracting visibility and investigator payment operations, improving operational control, process effectiveness, and financial discipline.
• Serve as functional owner for clinical operations standards and SOPs/guidance, ensuring consistent sample and imaging oversight to reduce patient data risk and site burden.

Requirements

• Bachelor’s degree (BA/BS) in a scientific or healthcare discipline; advanced degree preferred.
• 12+ years of progressive experience in pharmaceutical or biotechnology clinical operations with demonstrated leadership responsibility across global clinical development programs.
• Proven experience establishing/scaling centralized Clinical Operations capabilities, including one or more: feasibility & planning/analytics, operational technologies (CTMS/eTMF), vendor alliance management, site contracts & investigator payments, and sample & imaging management.
• Strong end-to-end clinical trial conduct expertise (early- to late-phase), including protocol development, feasibility, start-up, execution, and close-out.
• Demonstrated strategic CRO/vendor oversight experience, including governance models, performance metrics, financial oversight, issue escalation, and continuous improvement.
• Deep knowledge of clinical trial operations frameworks and regulatory expectations (ICH-GCP, FDA, and global health authorities); willingness to travel as required (~10%).

Culture & Benefits

• Medical, dental, and vision insurance plus a 401(k) retirement plan with company match that vests fully on day one.
• Eight (8) weeks of paid parental leave after three (3) months of employment and paid time off including vacation, personal time, sick time, floating holidays, and eleven (11) company holidays.
• Additional voluntary benefits including flexible spending and health savings accounts, life/AD&D insurance, disability coverage, and supplemental insurance plans.
• Flexible spending, health savings accounts, commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs.
• Benefits are offered exclusively to permanent full-time employees; contractors are not eligible for benefits.

Hiring process

• Interviews focused on clinical operations leadership, capability building, vendor/system governance, and standards ownership.
• Evaluation of experience across global clinical development programs and cross-functional collaboration in matrixed environments.