Associate Director, Clinical Development Operations

Company: Keloniatx
Location: Boston
Posted on: April 1, 2025

Job Description:

Here at Kelonia Therapeutics, we aren't just a preclinical 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.At Kelonia, 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-one that values both skill and care.Are you ready to be a part of our remarkable journey? We're looking for someone exceptional to join our growing team as a Clinical Development Ops professional in the Clinical group. This isn't just a job; it's an opportunity to contribute to groundbreaking therapies, to be part of a company's inception, and to make a transformative impact on patients' lives. If you're passionate about scaling a company from the ground up, making a real difference, and shaping the inclusive culture we're proud of, this opportunity is tailor-made for you. Join us and be a driving force in achieving excellence in viral engineering.What You'll Do:

• Manage the day-to-day operations of multiple clinical studies, ensuring effective execution from planning through completion.
• Collaborate with and oversee external vendors (CROs, clinical sites, central labs) to align on operational goals, timelines, and financial objectives.
• Develop, maintain, and update study-related tools, templates, and documentation to support trial activities.
• Proactively identify and mitigate potential risks to ensure study success.
• Provide regular, clear updates on study progress, metrics, and any issues to leadership.
• Contribute to financial planning and budgeting, including forecasting, tracking accruals, and ensuring compliance with study budgets.
• Manage site payments and ensure timely, compliant processing.What You'll Bring:
• 10+ years of experience in clinical research or operations, with a solid understanding of the drug development process.
• Strong organizational and project management skills with the ability to manage multiple competing priorities.
• Experience working with and managing clinical development operations vendors.
• Working knowledge of clinical trial regulations (e.g., Federal Regulations, ICH GCP); familiarity with international trial operations is a plus.
• Excellent interpersonal, written, and verbal communication skills for effective collaboration with diverse stakeholders.
• Experience or interest in innovative therapeutic areas such as oncology, cell therapy, or gene therapy is a plus.At Kelonia, we are dedicated to promoting a healthy work-life balance, and our benefits are designed to reflect that commitment. Alongside Flexible Time Off (FTO), we offer a flexible scheduling environment that empowers employees to work in a way that aligns with both their needs and our company's objectives. We also provide a team-focused environment with a competitive benefits package, including health, dental, commuter benefits, and more. At Kelonia, we foster a collaborative and inclusive workplace where you can join a small team that values both talent development and achieving company goals.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-timeLocation: Boston, MA
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Keywords: Keloniatx, Boston , Associate Director, Clinical Development Operations, Executive , Boston, Massachusetts