Associate Director, Clinical Operations

Candel Therapeutics•Needham, MA

51d•$170,000 - $215,000•Hybrid

About The Position

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.

Requirements

Bachelor’s degree in a scientific, medical, or healthcare-related discipline required
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
Must be authorized to work in the United States. We are unable to accommodate sponsorship now or in the future.

Nice To Haves

Advanced degree preferred
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

Responsibilities

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