Hybrid Senior Director, Oncology Clinical Science

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

Benefits offered by this job

Stock options

Performance bonus

401(k) plan

Comprehensive benefits

Job summary

ALX Oncology seeks a Senior Director of Clinical Science to advance ALX2004 and drive clinical development strategy. You will monitor trials, author protocols, and manage regulatory documents, closely collaborating with medical leads and CROs.

In this hybrid role, you will own key deliverables, interpret complex data, plan regulatory submissions, and contribute to publications while supporting the broader clinical program in a fast-paced biotech setting.

Qualifications

• PhD or MD with 10+ years oncology clinical development experience.
• Hands-on medical monitoring of trials, SAEs and expedited safety reports.
• Strong oncology knowledge and clinical pharmacology understanding.
• Experience authoring protocols and regulatory submissions.
• Experience with biologic and/or small-molecule therapies.
• Knowledge of FDA/EMA, GCP, ICH guidelines and regulatory processes.
• Excellent written and verbal communication with cross-functional teams.

Responsibilities

• Provide trial monitoring for Phase 1–3 trials with CRO medical monitors.
• Author clinical study protocols, amendments and eCRFs.
• Develop study timelines with operations and CROs for trials.
• Coordinate safety monitoring with Pharmacovigilance teams.
• Interpret trial data and support regulatory filings.
• Contribute to reporting and publications of ALX Oncology trials.
• Lead regulatory submission sections with the program/medical leads.
• Collaborate on Breakthrough/Fast Track designations and IND activities.
• Ensure compliance with GCP and regulatory requirements.
• Engage oncology investigators to strengthen study design and reporting.
• Participate in advisory boards and protocol training sessions.

Skills

Trial monitoring

Regulatory submissions

Clinical study design

Data interpretation

Cross-functional collaboration

GCP/ICH knowledge

Leadership experience

Education

PhD/MD with 10+ years oncology clinical development

Tools

eCRF development

Spotfire

IVRS

EDC systems

Job description

ALX Oncology seeks a Senior Director of Clinical Science to advance ALX2004 and drive clinical development strategy. You will monitor trials, author protocols, and manage regulatory documents, closely collaborating with medical leads and CROs.

In this hybrid role, you will own key deliverables, interpret complex data, plan regulatory submissions, and contribute to publications while supporting the broader clinical program in a fast-paced biotech setting.