Director, Clinical Scientist

Kumquat Biosciences Inc • San Diego, CA

5d

About The Position

The Director, Clinical Scientist is an integral member of a cross-functional team supporting a study drug from first-in-human development through registration. The role provides input into and helps execute the clinical development plan, including developing and executing protocols and protocol amendments. It provides clinical and scientific expertise across clinical trials and enabling projects, contributes to trial outcomes, and supports study teams, investigators, sites, vendors, and external stakeholders across geographies. The position also helps ensure GCP/GVP compliance, data integrity, and adherence to applicable ICH, GCP, and regulatory guidelines.

Requirements

• Bachelor of Science or Bachelor of Arts; an advanced degree is preferred.
• Oncology and/or hematology focus.
• At least 5 years of relevant experience in the pharmaceutical industry, a community setting, or academia.
• Working knowledge of drug development and clinical development activities and deliverables.
• Ability to solve complex problems, take a new perspective on existing solutions, and exercise judgment based on analysis of multiple sources of information and advice.
• Ability to travel up to 10% domestically or internationally.
• Excellent problem-solving skills and a proven track record of delivering to aggressive timelines.
• High ethical and professional standards, with the ability to work in accordance with regulations and company policies and procedures.
• Proficiency with MS Office, including Word, Excel, and PowerPoint.

Nice To Haves

• Phase 1 study trial experience in solid tumors or hematologic malignancies, with a focus on small molecules.

Responsibilities

• Perform ongoing clinical data review and analysis to ensure data integrity, identify trends, and support safety and efficacy assessments.
• Review and interpret clinical data, investigate unexpected findings, and provide meaningful insights to study teams.
• Support medical monitoring, including review of adverse events, protocol deviations, and long-term safety and efficacy outcomes.
• Provide input into and help execute the clinical development plan, including developing and executing protocols and protocol amendments.
• Participate in study and 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.
• Partner with 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 a culture of curiosity to enable faster, simpler, and more patient-centric study operations.
• Work with colleagues across Kumquat to promote communication and community, optimize growth opportunities and capabilities, contribute effectively in a diverse and global environment, and identify opportunities for value creation.
• Ensure GCP/GVP compliance and data integrity, take a balanced risk-based approach, and seek guidance or direction as needed.
• Provide subject matter expertise in supporting the design and execution of clinical trials and enabling projects across geographies.
• Contribute to the outcomes of one or more clinical trials or enabling projects.
• Apply knowledge of and ensure adherence to ICH, GCP, and regulatory guidelines in clinical trials or enabling activities.
• Participate in identifying vendors, build relationships with sites and investigators, and partner with them to support clinical trial execution.
• Work closely with investigators and clinical site staff.

What This Job Offers

• Job Type: Full-time
• Career Level: Director