Director/Sr. Director, Clinical Operations

United States·BostonFull Timesenior

OtherClinical Operations

0 views0 saves0 applied

Apply Now

Quick Summary

Overview

Here at Kelonia Therapeutics, we aren’t just a clinical company; we’re trailblazers in viral engineering, pushing the boundaries of in vivo lentiviral gene and cell therapy. We're not just a team; we're dreamers on a mission to bring the promise of cell and gene therapy to every patient in need.

Key Responsibilities

Clinical Trial Execution & Program Ownership 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…

Technical Tools

gcpmentoring

Here at Kelonia Therapeutics, we aren’t just a clinical company; we’re trailblazers in viral engineering, pushing the boundaries of in vivo lentiviral gene and cell therapy. We're not just a team; we're dreamers on a mission to bring the promise of cell and gene therapy to every patient in need.

We've gathered a group of pioneers in cell and gene therapy to lead our journey, with extraordinary scientific founders at the helm, providing the cutting-edge technology that sets us apart. We're not just building a company; we're cultivating a culture that values both skill and care.

What You Will Do:

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
CMC / Manufacturing

Ensure seamless communication of timelines, risks, and decisions across teams
Represent clinical operations in program-level discussions and decision-making

Build and implement study-level processes, tools, and tracking mechanisms
Contribute to the development of broader clinical operations infrastructure in partnership with the VP
Identify gaps in execution and proactively implement improvements

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
Embed a culture of proactive quality and operational excellence

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

What You Will Bring:

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