Associate Director, Clinical Operations
Functional Area

Clinical Operations
Reports To

Vice President, Clinical Operations or delegate
Location

Hybrid role based in Needham, MA
Compensation

$170,000-$200,000 salary + annual bonus + options
Position Summary

We're looking for an Associate Director, Clinical Operations to lead execution of global oncology clinical studies with strategic oversight, operational excellence, and a collaborative leadership style. This is a highly visible role responsible for end-to-end operational strategy and execution of one or more Phase 2 and Phase 3 oncology trials.

You'll work closely with cross-functional teams, CROs, vendors, clinical sites, and internal stakeholders to ensure studies are delivered on time, within budget, and with the highest quality standards.

This role is ideal for someone who thrives in a fast-paced biotech environment, can independently lead complex global studies, proactively solve problems, and confidently navigate ambiguity while remaining hands-on and team-oriented.
What You'll Do
• Lead operational planning and execution of assigned clinical studies, ensuring alignment with development timelines and program objectives
• Provide strategic oversight and leadership to cross-functional study teams including CTMs, CTAs, CRAs, vendors, and CRO partners
• Coordinate study execution from startup through database lock and closeout including site activation, enrollment tracking, monitoring oversight, and issue escalation
• Partner closely with CROs and external vendors to ensure adherence to project timelines, scope, quality expectations, and budget
• Monitor study progress and proactively identify operational risks, implementing mitigation strategies to support successful trial execution
• Conduct co-monitoring visits as needed and support oversight of CRAs and site performance
• Contribute to development and review of study protocols, amendments, informed consent forms, CRFs, study manuals, and operational plans
• Support inspection readiness activities including risk assessments, audit preparation, and serving as an operational lead during regulatory inspections
• Partner with Clinical Operations leadership on study budgets, accrual forecasting, invoice review, and financial tracking
• Drive continuous improvement initiatives through SOP development, process optimization, and implementation of operational best practices
• Mentor and support junior team members while contributing to a collaborative and accountable team culture
What You Bring
• Bachelor's degree in a scientific, medical, or healthcare-related discipline required; advanced degree preferred
• Approximately 8+ years of progressive experience in clinical trial operations
• Recent experience independently managing complex Phase 2 and Phase 3 oncology clinical trials
• Strong understanding of ICH-GCP guidelines and global regulatory requirements governing clinical research
• Experience overseeing CROs, external vendors, and global study execution in a biotech or pharmaceutical environment
• Proven ability to manage operational complexity while remaining hands-on and solutions-oriented
• Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment
• Excellent written, verbal, and cross-functional communication skills
• Experience participating in regulatory inspections and inspection readiness activities preferred
• Experience mentoring or guiding junior team members preferred
• High emotional intelligence, strong collaboration skills, and a humble, team-first mindset
Why You'll Succeed at Candel
• You know how to lead through complexity while remaining calm, organized, and proactive
• You're comfortable rolling up your sleeves and stepping into hands-on operational challenges when needed
• You thrive in lean, fast-moving biotech environments where visibility and ownership are high
• You value collaboration, transparency, accountability, and continuous improvement
• You care deeply about patients, science, and building strong relationships across teams
Work Environment

This is a hybrid position based in the Greater Boston area. Onsite presence is expected several days per week based on business needs and cross-functional collaboration.

Occasional domestic travel (~20%) may be required for site visits, co-monitoring, inspections, or investigator meetings.
Additional Information

Must be authorized to work in the United States. We are unable to accommodate sponsorship now or in the future.

NOTE: We are not currently partnering with external agencies for this search. We kindly ask that agencies refrain from direct outreach regarding candidate submissions or recruiting services.