Director, Clinical Scientist

Kumquat Biosciences Inc.

. Perform ongoing clinical data review and analysis to ensure data integrity, identify trends, and support safety and efficacy assessments .

Posted 11/3/2026full-timeRemote • California • United StatesLead💰 $190,000 - $225,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical data review and analysis, ensuring data integrity and compliance with ICH and GCP guidelines. Proven ability to support clinical trial execution and contribute to regulatory documents while fostering collaboration with stakeholders.

Highest-signal resume keywords

Clinical Data ReviewGCP ComplianceOncology FocusPhase 1 Study ExperienceDrug Development Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial DesignData AnalysisProtocol DevelopmentRegulatory Document PreparationAdverse Event ReviewTrend IdentificationSafety AssessmentsClinical MonitoringRisk-Based ApproachVendor Relationship Management

Soft Skills

Problem-SolvingCollaborationCommunicationJudgmentEthical Standards

Tools & Technologies

MS Office

Industry Keywords

Clinical TrialsHematologySolid TumorSmall MoleculesClinical Development PlanInformed Consent FormsInvestigator’s BrochuresDSURsStudy Start-Up ActivitiesPatient-Centric Operations

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Perform ongoing clinical data review and analysis to ensure data integrity, identify trends, and support safety and efficacy assessments
Review and interpret clinical data to identify trends, investigate unexpected findings, and provide meaningful insights to study teams
Support medical monitoring activities, including review of adverse events, protocol deviations, and long-term safety and efficacy outcomes
Provide input and execution of the clinical development plan by helping to develop and execute protocols and protocol amendments
Actively participate in study/site start-up activities, site engagement, including SIVs and committees, and provide general clinical support to study teams
Contribute to clinical and regulatory documents including Clinical Study Reports, informed consent forms, Investigator’s Brochures, and DSURs
Serve as a partner to external stakeholders in various countries and support local needs
Maintain up-to-date knowledge of the emerging treatment landscape in study-specific areas
Cultivate peer-to-peer collaborations and support patient-centric study operations
Work with colleagues across Kumquat to promote communication, community, and growth opportunities
Ensure GCP/GVP compliance, data integrity, and a balanced risk-based approach
Provide subject matter expertise supporting the design and execution of clinical trials and enabling projects across geographies
Contribute to the outcomes of clinical trials and enabling projects
Apply ICH, GCP, and regulatory guidelines within clinical trials or enabling activities
Participate in identifying vendors, building relationships with sites and investigators, and supporting trial execution
Work closely with investigators and clinical site staff

Requirements

What you’ll need

BS/BA with advanced degree preferred
Oncology and or hematology focus
At least 5 years of relevant experience either in the pharmaceutical industry, community setting or academia
Phase 1 study trial experience in either solid tumor or hematologic malignancies with a focus on small molecules preferred
Working knowledge of Drug Development and Clinical development activities and deliverables
Ability to solve complex outcomes; takes a new perspective on existing solutions; exercises judgment based on analyzing multiple sources of information and advice
Ability to travel up to 10% of the time domestically or internationally
Excellent problem-solving skills and proven track record of delivering to aggressive timelines
High ethical and professional standards, working in accordance with regulations and company policies and procedures
Proficient use of MS Office (Word, Excel, PowerPoint)