Senior Director/Executive Director of Clinical Operations

13 hours ago

California, United States BlossomHill Therapeutics, Inc. Full time
About Us

BlossomHill Therapeutics, Inc. is a pioneering company dedicated to revolutionizing precision medicine and improving life expectancy and quality of life for patients. Our cancer therapies are designed to be potent against cancer drivers and address resistance to treatment from multiple angles. Our autoimmune programs aim to tackle challenging diseases and deliver life-changing therapies.

We approach drug design from the ground up, combining human intelligence, creative thinking, and proven expertise to develop small-molecule masterpieces that set new standards for cancer and autoimmune disease treatment.

Job Summary

The Senior Director/Executive Director of Clinical Operations will lead the planning, execution, and management of clinical studies within our portfolio. This role requires a strong leader who can oversee study operations, financial oversight, vendor management, and people management, while advancing company goals through active contribution to clinical development strategy.

Key Responsibilities
  1. Develop and execute the overall clinical operations strategy, ensuring timely completion of studies within budget and adherence to SOPs and regulations.
  2. Supervise and direct clinical trials, ensuring compliance with FDA guidelines, including IND and GCP regulations.
  3. Manage budget, cost controls, and resource planning to meet corporate objectives.
  4. Recruit, mentor, and manage junior clinical operation staff, including identifying and evaluating contractors to execute clinical studies.
  5. Act as the primary contact with CROs and vendors for study-related matters, including clinical planning, patient recruitment, and monitoring of progress.
  6. Plan study operation strategy, including vendor selection, study footprint planning, and country/site prioritization.
  7. Direct, coach, and evaluate the operational activities of operational staff.
  8. Review and approve vendor invoices, manage monthly accruals, and ensure timely payment processing.
  9. Work with data management team on eCRFs for content, clarity, completeness, and performance in accordance with protocols and data requirements.
  10. Ensure timely and accurate data capture by sites, and promptly address anomalies or delayed entries through communications with CRO, CRAs, and sites.
  11. Maintain clinical records in clear and required formats.
  12. Aid in the preparation of clinical sections for all regulatory filings, including IND, Annual Reports, AE/SAE reporting, and study reports.
  13. Influence collaborators and consultants by demonstrating a deep understanding of all aspects of the company's projects, data, results, and objectives.
  14. Improve quality results by studying, evaluating, and re-designing processes and implementing changes that augment the company's mission, vision, values, and goals.
Qualifications
  • B.S. in scientific or business-related field.
  • 15+ years of clinical operations experience, including leadership roles in conducting Phase 1-3 multinational studies (Oncology experience strongly preferred).
  • Minimum 8 years in study management and 5 years in people management.
  • Strong knowledge of FDA guidelines, including IND and GCP regulations.
  • Experience in conducting international studies.
  • Proficiency in Electronic Data Capture, Clinical Trial Management Systems, and Trial Master File Maintenance.
  • Ability to communicate and collaborate with vendor CROs.
  • Ability to exercise independent judgment and discretion.
  • Demonstrate a high level of leadership and professionalism to build external relationships crucial to the success of the organization.
  • Strong attention to detail, organizational, time management, and communication skills.

BlossomHill Therapeutics, Inc. is an equal employment opportunity employer and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

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