Director/Senior Director of Clinical Operations

About Kelonia Therapeutics

Kelonia Therapeutics is a pioneering company specializing in viral engineering to advance in vivo lentiviral gene and cell therapies. Driven by visionary scientific founders, the company is dedicated to making transformative cell and gene therapies accessible to every patient requiring treatment. The organization fosters a culture of innovation combined with compassion for its team and mission.

Key Responsibilities

• Oversee full lifecycle management of clinical trials from initiation to closure, ensuring alignment with development strategy through detailed operational plans, schedules, and financial management.
• Ensure timely and compliant study delivery within scope and budget by proactively identifying and mitigating risks to maintain clinical program progress.
• Direct day-to-day interactions with Contract Research Organizations (CROs) and external vendors, monitoring performance metrics, quality standards, and accountability, escalating concerns when necessary.
• Collaborate with senior leadership and cross-functional teams in clinical development, translational research, regulatory affairs, and manufacturing to coordinate activities and communicate effectively across stakeholders.
• Develop and implement robust study-specific processes, tracking tools, and operational frameworks to enhance clinical operations efficiencies and address gaps.
• Maintain adherence to ICH-GCP guidelines, regulatory standards, and internal policies; ensure Trial Master File completeness and support audit and inspection readiness.
• Lead and mentor clinical operations personnel, fostering a culture of responsibility, prioritization, and high performance; contribute to recruitment and organizational growth of the clinical function.

Qualifications

• Bachelor’s degree in life sciences or related discipline required; advanced degrees preferred.
• Ten or more years of clinical operations experience for Director level; twelve or more years for Senior Director.
• Proven leadership in early-phase oncology clinical trials, especially Phase I/II.
• Preferred expertise in hematologic cancers and cell/gene therapy modalities.
• Strong track record managing CROs and complex cross-functional clinical trial programs.
• Extensive knowledge of ICH-GCP, global regulatory requirements, and clinical trial systems (e.g., CTMS, eTMF, EDC).
• Exceptional planning, risk management, budget control, and execution skills in a dynamic, fast-paced environment.
• Superior communication skills with an ability to influence across functions and drive results effectively.

Compensation and Benefits

The role offers a competitive salary based on experience and qualifications:

• Director: $190,000 to $252,000 annually
• Senior Director: $228,000 to $286,000 annually

Kelonia Therapeutics supports a healthy work-life balance with flexible time off and adaptable scheduling. Employees are provided with a comprehensive benefits package, including health coverage and commuter benefits, as well as access to on-site amenities such as free parking, a modern gym, and a food hall. The company emphasizes inclusive teamwork and professional development.

Additional Information

Kelonia Therapeutics is an equal opportunity employer committed to diversity and non-discrimination across all protected characteristics. The company does not consider unsolicited resumes from external sources. Artificial intelligence tools may assist in the recruitment process, but hiring decisions are made by human evaluators only. For inquiries about data processing, applicants may reach out directly.

Job Specifics

Employment Type: Full-time
Work Type: Onsite
Location: Boston, MA