Director, Clinical Scientist

This is a fully remote position, open to applicants in California.

📋 Description

• Conduct continuous clinical data reviews and analyses to ensure data integrity, pinpoint trends, and support evaluations of safety and efficacy.

• Analyze and interpret clinical data to uncover trends, explore unexpected results, and deliver valuable insights to study teams.

• Assist in medical monitoring efforts, including the review of adverse events, protocol deviations, and long-term safety and efficacy results.

• Contribute to the clinical development plan by aiding in the creation and implementation of protocols and protocol amendments.

• Engage actively in study/site initiation activities, site engagement including SIVs and committees, and provide overall clinical support to study teams.

• Assist in the preparation of clinical and regulatory documents such as Clinical Study Reports, informed consent forms, Investigator’s Brochures, and DSURs.

• Collaborate with external stakeholders in various countries and address local requirements.

• Stay informed about the evolving treatment landscape in study-specific areas.

• Foster peer-to-peer collaborations and facilitate patient-focused study operations.

• Collaborate with colleagues across Kumquat to enhance communication, community, and growth opportunities.

• Ensure compliance with GCP/GVP standards, maintain data integrity, and uphold a balanced risk-based approach.

• Provide subject matter expertise to support the design and implementation of clinical trials and enabling projects across different regions.

• Contribute to the results of clinical trials and enabling initiatives.

• Implement ICH, GCP, and regulatory guidelines within clinical trials or enabling activities.

• Assist in identifying vendors, building relationships with sites and investigators, and supporting trial execution.

• Collaborate closely with investigators and clinical site personnel.

⛳️ Requirements

• Bachelor’s degree with an advanced degree preferred.

• Focus on oncology and/or hematology.

• Minimum of 5 years of relevant experience in the pharmaceutical industry, community setting, or academia.

• Experience in Phase 1 clinical trials related to solid tumors or hematologic malignancies, with an emphasis on small molecules preferred.

• Familiarity with drug development and clinical development activities and deliverables.

• Ability to resolve complex outcomes; adopt new perspectives on existing solutions; and exercise judgment based on the analysis of multiple information sources.

• Willingness to travel up to 10% of the time, both domestically and internationally.

• Outstanding problem-solving abilities with a proven history of meeting aggressive timelines.

• High ethical and professional standards, adhering to regulations and organizational policies and procedures.

• Proficient in using MS Office applications (Word, Excel, PowerPoint).

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and growth.

• Flexible work arrangements to promote work-life balance.

• Collaborative and inclusive workplace culture.