Hybrid Senior Director, Clinical Science

ALX Oncology Inc.; South San Francisco (CA); Hybrid; USD 305,000 - 325,000; Full time

Benefits offered by this job

Stock options

Performance-based bonus

401K

Comprehensive benefits

Job summary

ALX Oncology Inc. is seeking a Senior Director, Clinical Science to advance ALX2004 through hands-on clinical development leadership, trial monitoring, and strategy development.

You will author study protocols, regulatory documents, and safety reports while partnering with medical leads, CROs, investigators, and cross-functional teams worldwide. The role requires extensive oncology clinical development experience, strong regulatory expertise, and the ability to drive timelines and data integrity

Qualifications

• PhD or MD with 10+ years in oncology clinical development.
• Extensive hands-on medical monitoring and safety evaluation.
• Strong regulatory submission experience and scientific writing.
• Deep knowledge of FDA/EMA guidelines and GCP.

Responsibilities

• Provide trial monitoring for Phase 1–3 trials in collaboration with ALX and CRO monitors.
• Author clinical study protocols, amendments, and related documents including eCRFs.
• Coordinate study timelines with Clinical Operations and CROs to execute trials.
• Coordinate integrated safety monitoring activities with Pharmacovigilance.
• Review and interpret trial data with Data Management for reporting and regulatory filings.
• Lead reporting and publication of ALX-sponsored trials.
• Contribute to regulatory submissions including IND/BLA sections with cross-functional input.
• Collaborate with Research on regulatory submissions and Breakthrough/FT designations.

Skills

Trial monitoring

Data interpretation

Regulatory submissions

Clinical development

Scientific writing

Cross-functional collaboration

Education

PhD or MD in oncology

Tools

Spotfire

IVRS

EDC systems

PowerPoint

Excel

Outlook

Job description

ALX Oncology Inc. is seeking a Senior Director, Clinical Science to advance ALX2004 through hands-on clinical development leadership, trial monitoring, and strategy development.

You will author study protocols, regulatory documents, and safety reports while partnering with medical leads, CROs, investigators, and cross-functional teams worldwide. The role requires extensive oncology clinical development experience, strong regulatory expertise, and the ability to drive timelines and data integrity