Director/Sr. Director, Clinical Operations

Kelonia Therapeutics

Director/Sr. Director overseeing clinical trial execution at Kelonia Therapeutics.

Posted 5/5/2026full-timeBoston • Massachusetts • 🇺🇸 United StatesSenior💰 $190,000 - $252,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead the end-to-end execution of clinical trials from study start-up through close-out
Translate clinical development strategy into actionable operational plans, timelines, and budgets
Own study-level delivery, ensuring trials are conducted on time, within budget, and in compliance
Identify risks early and drive mitigation strategies to maintain program momentum
Lead day-to-day oversight of CROs and external vendors, ensuring performance, quality, and accountability
Define and track KPIs and deliverables, escalating issues as needed
Partner with VP and cross-functional stakeholders on vendor selection and governance
Act as the primary escalation point for operational challenges
Drive alignment across Clinical Development, Translational & Research, Regulatory, and CMC / Manufacturing
Ensure seamless communication of timelines, risks, and decisions across teams
Build and implement study-level processes, tools, and tracking mechanisms
Contribute to the development of broader clinical operations infrastructure in partnership with the VP
Ensure study execution aligns with ICH-GCP, regulatory requirements, and internal SOPs
Oversee TMF quality and completeness at the study level, ensuring inspection readiness
Support audits and inspections in collaboration with Quality and VP Clinical Operations
Provide direction and mentorship to clinical operations staff (e.g., CTAs, CTMs) as applicable
Foster accountability, prioritization, and strong execution across the study team
Contribute to hiring and scaling of the clinical operations function

Requirements

What you’ll need

Bachelor’s degree in life sciences or related field; advanced degree preferred with 10+ years (Director) / 12+ years (Senior Director) in clinical operations
Demonstrated experience leading early-phase oncology clinical trials (Phase I/II)
Experience in hematological malignancies and cell and gene therapy strongly preferred
Proven success managing CROs and cross-functional clinical programs
Deep understanding of clinical trial execution, ICH-GCP, and global regulatory requirements
Experience with clinical systems (e.g., CTMS, eTMF, EDC)
Strong operational planning and risk management capabilities
Experience managing study budgets and timelines
Strong execution mindset with end-to-end ownership of deliverables
Ability to operate effectively in a lean, ambiguous, and fast-moving environment
Skilled at balancing strategic thinking with hands-on execution
Excellent communication and cross-functional influence
Proactive problem solver with a focus on delivering results

Benefits

Comp & perks

Flexible Time Off
flexible scheduling that aligns with your needs and our objectives
a competitive benefits package (health, commuter, and more)
free parking
state-of-the-art gym
food hall
collaborative, inclusive team that invests in your development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical trial executionoperational planningrisk managementbudget managementtimelines managementoncology clinical trialshematological malignanciescell and gene therapycross-functional program managementstudy-level processes

Soft Skills

leadershipcommunicationproblem solvingaccountabilityprioritizationexecution mindsetstrategic thinkinginfluencementorshipcollaboration

Certifications

Bachelor’s degree in life sciencesadvanced degree in related fieldICH-GCP certification