Overview
We are looking for a highly experienced and results-driven Head of Clinical Operations to join our team at Kumquat Biosciences. As the Head of Clinical Operations, you will be responsible for overseeing the planning, execution, and delivery of clinical trial programs in collaboration with the medical product leads. This individual will oversee clinical operations across multiple studies and be responsible for operational excellence to meet corporate and clinical program goals. An ideal candidate is a strategic thinker with deep experience in clinical operations and cross-functional collaboration with excellent communication skills in the life sciences or healthcare industry.
Key Responsibilities:
- Oversee the day-to-day clinical operations team, including Clinical Operations Study Leads (COSLs), Clinical Research Associates (CRAs), and other operations staff.
- Develop and implement SOPs, work instructions, tools, templates, workflows, and study-level performance metrics to optimize operational efficiency and compliance.
- Strike new and manage existing business relationships with CROs, clinical sites, vendors, and consultants to ensure high-quality vendor performance and financial accountability.
- Collaborate with Medical, Clinical Science, Data Management, Quality Assurance, Regulatory, Clinical Supply, Regulatory and other departments to support clinical development programs.
- Perform as a key member of a product development team to provide timelines, budgets, feasibility, and product strategy
- Support COSLs in study start-up, development of study budgets, plans, and timely and quality study execution with excellent vendor oversight.
- Monitor clinical trial progress, identify risks and mitigation strategies, and provide regular updates to leadership.
- Help strategize with study teams for rapid study start-up, site initiation, accruals to assigned product trials, and rapid database locks (60 days or less).
- Ensure compliance with ICH-GCP guidelines, FDA regulations, and other applicable global regulatory requirements.
- Lead and mentor team members, fostering a high-performance culture and supporting professional development.
- Help lead inspection readiness initiative and regulatory authority inspections/audits. Be a key member of the audit response team.
Requirements
- Bachelor's degree in a related field (Life Sciences, Nursing, etc.).
- Minimum of 12 years of clinical research experience, including 5+ years in a leadership or management role.
- Experience in early-phase oncology trials, and/or immunology and inflammation (I & I) trials, biomarker driven therapy, and small molecule drugs
- Clinical operations lead of a minimum of 1 prior successful product approval and NDA submission with experience of a minimum of 1 accelerated approval pathway and compressed regulatory timelines
- Experience in global clinical trials, early and late phase research
- Strong understanding of clinical development processes, ICH-GCP, FDA, and international regulatory requirements.
- Proven track record of successfully managing global clinical trials across all phases.
- Excellent leadership, communication, and interpersonal skills.
- Ability to thrive in a fast-paced, dynamic, and collaborative environment.
