Associate Director, TMF Operations

Candel Therapeutics•Needham, MA

12d•$184,000 - $210,000•Hybrid

About The Position

Candel is a clinical-stage biopharma company developing off-the-shelf, multimodal immunotherapies that stimulate personalized, systemic anti-tumor responses. Our platforms use genetically modified adenovirus and HSV constructs. With positive Phase 3 results for our lead candidate, it’s an exciting time to join us and help bring transformative cancer treatments to patients. We’re looking for an experienced Associate Director, Trial Master File (TMF) Operations to lead the Trial Master File operations across our oncology clinical programs. This role is ideal for someone who enjoys creating structure in a fast-paced biotech environment and can confidently partner across Clinical Operations, Quality, Regulatory, IT, and external vendors to ensure inspection readiness and operational excellence. You’ll play a critical role in strengthening TMF strategy, oversight, quality, and reporting infrastructure while helping build scalable processes that support a growing clinical portfolio. This is a highly visible opportunity for someone who combines strategic thinking with hands-on execution and enjoys driving continuous improvement.

Requirements

Bachelor’s degree in a scientific, healthcare, or related discipline, or equivalent industry experience
10+ years of clinical research experience within biotech, pharmaceutical, or CRO environments
Strong background in TMF operations, document management, and inspection readiness activities
Hands-on experience managing eTMF systems and TMF reporting processes
Deep understanding of ICH-GCP requirements, TMF best practices, and global regulatory expectations
Experience working collaboratively with CROs, vendors, and cross-functional stakeholders in a matrixed environment
Ability to operate effectively in a growing biotech company where priorities may evolve quickly
Strong organizational skills with the ability to manage multiple priorities while maintaining exceptional attention to detail
Excellent communication, collaboration, and problem-solving skills
A proactive mindset with the ability to work independently, influence others, and drive initiatives forward
Must be authorized to work in US. We are unable to provide any sponsorship at this time.

Responsibilities

Lead TMF operational strategy and help build scalable, inspection-ready processes across ongoing and future clinical studies
Drive oversight of electronic TMF activities to ensure quality, completeness, accuracy, and regulatory compliance across internal teams and external partners
Develop and refine TMF standards, governance models, workflows, and procedural documentation aligned with industry best practices and global regulations
Act as a trusted TMF subject matter expert and strategic partner to Clinical Operations leadership and cross-functional stakeholders
Management of the eTMF system vendor
Establish and monitor TMF health metrics, dashboards, and operational KPIs to identify trends, risks, and opportunities for improvement
Conduct TMF reviews, quality assessments, and operational audits to ensure inspection readiness at all times
For outsourced studies, partner closely with CROs and vendors to ensure deliverables, timelines, expectations, and performance standards are consistently met
Support implementation, optimization, and integration of TMF-related systems and technologies including eTMF platforms, CTMS, EDC, and other clinical systems
Collaborate with IT and business stakeholders on system enhancements, upgrades, validation activities, and change management initiatives
Help drive operational excellence by identifying process gaps, improving workflows, and creating sustainable solutions that support organizational growth
Provide training and guidance to internal teams on TMF processes, expectations, and best practices
Support clinical trial disclosure and registry compliance activities in partnership with cross-functional teams