Associate Director/Director, Clinical Operations

Location: Hybrid work in Monmouth Junction, New Jersey; local candidates must work most of the week in the NJ office, while non-local candidates must attend the office multiple times a month.

Salary: Associate Director $165,000–$225,000 per year; Director $210,000–$250,000 per year.

Company

hirify.global is a privately owned US biopharmaceutical company focused on the research, development, manufacturing, and commercialization of branded, specialty generic, OTC, and prescription medicines.

What you will do

• Oversee operational delivery of complex clinical programs and studies, ensuring milestones, quality, timelines, and budgets are achieved.
• Lead cross-functional teams and provide operational strategies, scenario models, executive updates, and risk escalation.
• Review clinical development documents, including study synopses, protocols, clinical study reports, and project plans.
• Manage study budgets, CRO and vendor selection, governance, oversight, and performance throughout the study lifecycle.
• Provide sponsor oversight of monitoring visits and manage CRA and Clinical Trial Assistant teams.
• Support SOP development, standardized processes, inspection readiness, and department initiatives.

Requirements

• Bachelor’s degree in a scientific or healthcare field.
• At least 7 years of clinical development or clinical operations experience, primarily in clinical study or project management roles with increasing leadership responsibility.
• Hands-on experience with early-phase and Phase I–III clinical studies.
• Experience overseeing CROs and other clinical trial vendors across the study lifecycle.
• Expertise in global clinical research regulations and compliance, including US CFR, EUCTD, and ICH GCP; working knowledge of CFR Title 21 Parts 314.80, 314.81, and 314.98.
• Demonstrated project or program management, matrix leadership, and ability to influence without direct authority.

Culture & Benefits

• Hybrid work environment with regular office attendance in New Jersey.
• Full-time employees are eligible for performance incentives and bonus compensation.
• Medical, dental, vision, prescription, life insurance, and 401(k) with company match.
• Paid company holidays, paid time off, and paid volunteer time.
• Employee Resource Groups and an emphasis on respectful, open, and honest communication.