Director, Clinical Scientist

Kumquat Biosciences Inc.; San Diego (CA); Sur place; USD 180 000 - 240 000; Plein temps

Résumé du poste

Kumquat Biosciences Inc. is seeking a Director, Clinical Scientist to guide a cross-functional team from first-in-human studies through registration. You will help develop and execute protocols, monitor safety and efficacy, and contribute to regulatory documents across multiple geographies.

The role requires oncology/hematology expertise, significant phase 1 trial experience, and a strong ability to collaborate with investigators and stakeholders to advance patient-centric study outcomes.

Qualifications

• BS/BA with advanced degree preferred in a relevant field.
• Oncology and/or hematology focus.
• At least 5 years of relevant experience in pharma, community setting, or academia.
• Phase 1 trial experience in solid tumors or hematologic malignancies.
• Working knowledge of Drug Development and Clinical development deliverables.
• Ability to travel up to 10% domestically or internationally.
• Excellent problem-solving skills and ability to deliver to aggressive timelines.
• High ethical and professional standards with regulatory compliance.

Responsabilités

• Perform ongoing clinical data review and analysis to support safety and efficacy assessments.
• Review and interpret clinical data to identify trends and provide insights to study teams.
• Support medical monitoring activities including review of adverse events and protocol deviations.
• Provide input and execution of the clinical development plan and protocol amendments.
• Participate in start-up activities, site engagement, and general clinical support.
• Contribute to key documents (CSRs, IBs, DSURs) and regulatory submissions.
• Partner with external stakeholders across geographies to support local needs.
• Maintain up-to-date knowledge on the treatment landscape and drive value creation.

Formation

BS/BA with advanced degree (MS/PhD preferred)

Outils

MS Office

Description du poste

Description

The Director, Clinical Scientist is an integral member of a cross-functional team for a study drug from first in human to registration by providing input and execution of the clinical development plan by helping develop and execute protocols and protocol amendments.

Key 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 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 the study teams
• Contribute to key clinical and regulatory documents including Clinical Study Reports (CSRs), informed consent form(s), Investigator's Brochures (IBs), and DSURs
• Serve as a partner to external stakeholders in various countries and help support local needs
• Manage up-to-date knowledge on the emerging treatment landscape in study specific areas
• Cultivate meaningful peer-to-peer collaborations and nurture a culture of curiosity to enable faster, simpler, and more patient-centric ways of operating our studies
• Work with colleagues across Kumquat to promote communication and community. Optimizing growth opportunities and capabilities to successfully contribute and operate in a diverse and global environment. Drive new thinking by identifying new opportunities and options to embrace value creation.
• Ensure GCP/GVP compliance, data integrity, and take a balanced risk-based approach in the work you are focused on, seeking guidance or direction as needed.
• Provides subject matter expertise on activities or through supporting the design and execution of clinical trials and/or enabling projects across geographies.
• Contributes to the outcome of one or more clinical trials and/or enabling projects.
• Understands, applies proficient knowledge of, and ensures adherence to ICH, GCP, and regulatory guidelines within clinical trials or enabling activities.
• Participates in identifying vendors, builds relationships with sites and investigators and partners to ensure the execution of clinical trials.
• Work closely with Investigator and clinical site staff

Requirements

• 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)