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Jobs at Kumquat Biosciences Inc. (Now Hiring) — 1 open

Kumquat Biosciences Inc. logoKumquat Biosciences Inc.

Head of Clinical Operations

San Diego, California, United States · On-site

$225k–$325k/yr

Senior+$176M raised

Description 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 p…

Skills: Clinical Operations, Vendor Management, CRO Oversight, ICH-GCP Compliance, FDA Regulations

Kumquat Biosciences Inc. logo

Head of Clinical Operations

Kumquat Biosciences Inc.

San Diego, California, United States • On-site

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  • $225k–$325k/yr
  • Full-time
  • bachelor degree
  • Posted 17d ago
  • ~40 hrs/week

Responsibilities

Oversee the planning, execution, and delivery of clinical trial programs while managing the clinical operations team and vendor relationships. Ensure operational excellence and regulatory compliance across multiple studies to meet corporate and clinical program goals.

Requirements

Requires a bachelor's degree and at least 12 years of clinical research experience, including 5+ years in leadership. Must have a proven track record with early-phase oncology or immunology trials and at least one successful NDA submission.

Full job description

Description

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.

Related keywords

Clinical OperationsCROICH-GCPFDANDA SubmissionOncologyImmunologyBiomarker Driven TherapySmall Molecule DrugsClinical Research AssociatesSOPsClinical Trial ManagementRegulatory AffairsGlobal Clinical TrialsAccelerated Approval PathwayDatabase Locks

About Kumquat Biosciences Inc.

LinkedInVisit site
Industry
Biotechnology Research
Company size
11-50 employees
Headquarters
San Diego, California
LinkedIn followers
7,269
Total funding
$176M

Kumquat Biosciences’ vision is to develop innovative therapies to bring about sustainable and life-changing benefits to cancer patients. We are committed to translate breakthrough science to innovative medicines by combining internal expertise in drug discovery and development, with external collaboration with academics. Kumquat brings together an accomplished management team with proven track record in discovering and developing innovative oncology medicines. The founding team has previously co-founded Intellikine, Araxes/Wellspring Biosciences and Kura Oncology. Kumquat Biosciences currently focuses on multiple first-in-class programs including targeted therapy as well as immunotherapy. Kumquat is funded by leading biotech venture investors as well as a pharmaceutical corporate venture.

Offices: 3033 Science Park Rd, Suite 200, San Diego, California 92121, US

Alternative MedicineOncologyBiotechnologyTherapeutics
View all jobs at Kumquat Biosciences Inc.

About Kumquat Biosciences Inc.

LinkedInVisit site
Industry
Biotechnology Research
Company size
11-50 employees
Headquarters
San Diego, California
LinkedIn followers
7,269
Total funding
$176M

Kumquat Biosciences’ vision is to develop innovative therapies to bring about sustainable and life-changing benefits to cancer patients. We are committed to translate breakthrough science to innovative medicines by combining internal expertise in drug discovery and development, with external collaboration with academics. Kumquat brings together an accomplished management team with proven track record in discovering and developing innovative oncology medicines. The founding team has previously co-founded Intellikine, Araxes/Wellspring Biosciences and Kura Oncology. Kumquat Biosciences currently focuses on multiple first-in-class programs including targeted therapy as well as immunotherapy. Kumquat is funded by leading biotech venture investors as well as a pharmaceutical corporate venture.

Offices: 3033 Science Park Rd, Suite 200, San Diego, California 92121, US

Alternative MedicineOncologyBiotechnologyTherapeutics
View all jobs at Kumquat Biosciences Inc.

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