Associate Director, Clinical Data Management (Oncology)

Location: Palo Alto, California, United States

Salary: $174,000–$205,000 USD annually, with potential bonus, stock, benefits, and other variable compensation.

Company

hirify.global is a biopharmaceutical oncology company developing investigational therapies and conducting global Phase 3 clinical studies in non-small cell lung cancer and colorectal cancer.

What you will do

• Lead clinical data management activities across early- and late-phase clinical trials, including large and complex global programs.
• Plan and oversee CRF/eCRF design, database development, validation programming, data review, discrepancy management, and database lock.
• Develop clinical data standards, data management plans, data transfer agreements, and data flow processes.
• Manage and oversee CDM staff, CROs, vendors, and technology providers throughout the data management lifecycle.
• Coordinate with Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Regulatory, Quality Assurance, IT, and other functions.
• Support regulatory audits, risk mitigation, process improvement, resource planning, and departmental budget management.

Requirements

• Bachelor’s degree in Life Sciences, Computer Science, or a relevant field, or equivalent practical experience.
• 10+ years of clinical data management experience in the biotechnology or pharmaceutical industry.
• Excellent understanding of late-phase clinical drug development processes; oncology experience is highly desirable.
• Experience with electronic data capture and other clinical data collection systems, including MedDRA and WHODRUG coding processes.
• Strong line management, supervisory, communication, interpersonal, and leadership skills.
• Strong knowledge of clinical research, FDA and ICH requirements, GCP, GCDMP, and related regulations.

Nice to have

• Experience overseeing CROs and vendors.
• Oncology experience.

Culture & Benefits

• Work within a mission-driven oncology organization focused on serious unmet medical needs.
• Company values include integrity, excellence, purposeful urgency, collaboration, and commitment to people.
• Total compensation may include bonus, stock, benefits, and other applicable variable compensation.
• Summit maintains offices in California, Florida, New Jersey, the United Kingdom, and Ireland.