Head of Clinical Operations

About the Role

Kumquat Biosciences is seeking a seasoned and results-oriented Head of Clinical Operations to steer the planning, execution, and successful delivery of clinical trial programs. This leadership role involves managing clinical operations over multiple studies, ensuring operational excellence aligns with company and clinical program goals. Ideal candidates will possess strategic insight, extensive clinical operations experience, and strong collaboration and communication skills within life sciences or healthcare sectors.

Key Responsibilities

• Manage daily activities of the clinical operations team, including Clinical Operations Study Leads (COSLs), Clinical Research Associates (CRAs), and other operations personnel.
• Create and enforce standard operating procedures (SOPs), operational guides, tools, templates, workflow processes, and study performance metrics to enhance compliance and efficiency.
• Establish new and maintain existing partnerships with CROs, clinical sites, vendors, and consultants to ensure superior vendor performance and financial responsibility.
• Partner with Medical, Clinical Science, Data Management, Quality Assurance, Regulatory, and Clinical Supply departments to advance clinical development programs.
• Act as a vital member of product development teams, providing input on timelines, budget planning, feasibility, and product strategy.
• Assist COSLs in study initiation, budget creation, planning, and overseeing study execution with strong vendor supervision.
• Track progress of clinical trials, identify potential risks, and implement mitigation plans while regularly updating leadership.
• Collaborate with study teams to accelerate study start-up, site initiation, patient enrollment, and achieve rapid database locks within 60 days.
• Ensure all operations comply with ICH-GCP standards, FDA regulations, and relevant international regulatory frameworks.
• Provide leadership and mentorship to team members to cultivate a culture of high performance and support professional growth.
• Lead efforts in inspection readiness and assist with regulatory authority inspections/audits, serving as a key participant in audit response processes.

Candidate Requirements

• A bachelor's degree in a relevant discipline such as Life Sciences or Nursing.
• A minimum of 12 years’ experience in clinical research, including over 5 years in a leadership or management capacity.
• Expertise in early-phase oncology trials or immunology and inflammation (I&I) trials, biomarker-driven therapies, and small molecule drug development.
• Experience leading clinical operations for at least one product that successfully achieved approval and NDA submission, including familiarity with accelerated approval pathways and compressed regulatory timelines.
• Proven experience managing global clinical trials across early and late phase research.
• Strong knowledge of clinical development procedures, ICH-GCP guidelines, FDA requirements, and international regulatory standards.
• Demonstrated successful track record overseeing global clinical trials at all stages.
• Outstanding leadership qualities, communication skills, and ability to foster interpersonal relationships.
• Capacity to excel in a dynamic, fast-moving, and collaborative work environment.