The Role
Lead clinical trial execution, manage CROs, drive cross-functional collaboration, ensure compliance, mentor team, and enhance operational processes.
Summary Generated by Built In
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:
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 delivery, ensuring trials are conducted on time, within budget, and in compliance
- Identify risks early and drive mitigation strategies to maintain program momentum
Vendor & CRO Management
- 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
Cross-Functional Program Leadership
- 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
Operational Planning & Infrastructure
- 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
Quality, Compliance & Inspection Readiness
- 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
Team Leadership & Development
- 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
The anticipated salary range for candidates for this is below. The final salary offered will depend on several factors, which may include, but is not limited to, relevant years of experience, skills, qualifications, job knowledge, and educational background.
$190,000 - $252,000 a year (Director)
$228,000 - $286,000 a year (Sr. Director)
At Kelonia, we’re serious about balance and growth. You’ll get Flexible Time Off, flexible scheduling that aligns with your needs and our objectives, a competitive benefits package (health, commuter, and more), and great on-site perks that include free parking, a state-of-the-art gym, and a food hall – all within a collaborative, inclusive team that invests in your development and makes big things happen together.
Kelonia Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Kelonia does not accept unsolicited resumes from any source other than directly from candidates.
Job Type: Full-time
Work Type: Flexible
Location: Boston, MA
Skills Required
- Bachelor's degree in life sciences or related field
- 10+ years (Director) / 12+ years (Senior Director) in clinical operations
- Experience leading early-phase oncology clinical trials (Phase I/II)
- Experience in hematological malignancies and cell and gene therapy
- 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 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
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The Company
What We Do
Kelonia is pioneering a new wave of genetic medicines using its next generation gene delivery platform. The company’s simple and elegant cutting-edge in vivo gene delivery technology uses a few potent lentiviral vector-like particles to precisely and efficiently deliver in vivo genetic cargo to the desired target tissue, and only that tissue, every time. With an initial focus on developing transformational therapies for solid tumors and hematologic cancers, Kelonia is building a pipeline of genetic medicines for a wide range of diseases, with the bold goal of bringing genetic medicines to every patient in need.
