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About the Role

The Sr. Director, Clinical Data Management provides strategic and operational leadership for the Clinical Data Management function, establishing a scalable function that delivers high-quality clinical trial data to support development milestones, regulatory submissions, and future portfolio growth in a lean biotechnology environment.

Responsibilities

• Lead the Clinical Data Management function by developing and executing strategies, processes, and operational plans.
• Oversee Clinical Data Management activities, including review and approval of key deliverables such as database design, eCRFs, edit checks, data review plans, and database lock activities.
• Lead data review, issue management, and milestone readiness to support interim analyses, database locks, and key development milestones.
• Serve as the primary escalation point for data management issues affecting study quality, timelines, or regulatory readiness.
• Oversee EDC and related clinical data systems, including implementation, configuration, and vendor management.
• Lead the selection, oversight, and performance management of CROs and specialty vendors, establishing governance, performance metrics, and communication processes.
• Manage vendor budgets and identify cost-effective solutions without compromising quality or compliance.
• Drive continuous improvement initiatives that enhance data quality, operational efficiency, and study execution.
• Partner with Clinical Operations, Biostatistics, Statistical Programming, Clinical Science, Medical, Safety, Regulatory, and Quality to support successful study execution.
• Provide data management expertise during protocol development, advising on data collection strategy, endpoint feasibility, and study design.
• Ensure clinical data are inspection-ready and support regulatory submissions, audits, safety reviews, and due diligence activities.
• Contribute to a culture that reflects ALX's values by acting with integrity, accountability, transparency, and respect.
• Build strong, collaborative relationships through active engagement with colleagues, including regular onsite participation consistent with the company's hybrid work model.

Requirements

• Approximately 12+ years of progressive Clinical Data Management experience within biotechnology, pharmaceutical, or CRO environments, including Phase I-III clinical studies.
• Demonstrated success leading outsourced Clinical Data Management activities, partnering across functions, and delivering high-quality clinical trial data.
• Experience supporting regulatory submissions is preferred.
• Oncology and/or immuno-oncology experience is strongly preferred.
• Strong knowledge of Clinical Data Management principles, GCP, applicable regulatory requirements, CDISC standards, and industry best practices.
• Demonstrated expertise in database design, data cleaning, medical coding, external data reconciliation, data review, database lock, and other core Clinical Data Management processes.
• Experience with leading EDC platforms such as Medidata Rave, Veeva EDC, Oracle Clinical, or equivalent systems.
• Demonstrated ability to effectively manage CROs, vendors, budgets, and outsourced Clinical Data Management activities.
• Strategic, collaborative leader with excellent communication, organizational, and relationship-building skills, capable of influencing cross-functional teams and external partners.
• Demonstrated ability to prioritize competing demands, solve complex problems, build scalable processes, and adapt to evolving business priorities while contributing beyond functional boundaries in a fast-paced, resource-constrained environment.

Skills

• Medidata Rave
• Veeva EDC
• Oracle Clinical
• CDISC standards
• GCP
• Clinical Data Management principles

Location

• South San Francisco, CA

Work Type

• Hybrid

Experience Level

• 12+ years

Education Level

• Bachelor's degree in Life Sciences, Statistics, Computer Science, or a related scientific discipline, or an equivalent combination of education and directly relevant work experience.
• Advanced degree (MS, MPH, PhD) is a plus.

Salary/Compensations

• $240,000 - $280,000

Benefits

• Stock programs
• Performance-based bonus
• Comprehensive benefits package including 401K

About the Company

• ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives.
• ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built.
• Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications.
• ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action.
• A Phase 1, dose-escalation trial of ALX2004 is ongoing in patients with EGFR-expressing solid tumors.
• More information is available at www.alxoncology.com and on LinkedIn @ALX Oncology.

Equal Opportunity

• ALX Oncology does not accept unsolicited resumes or candidate information from recruitment agencies, including blinded or anonymized resumes, and will not be responsible for any fees associated with unsolicited submissions.
• Do not contact hiring managers or other ALX Oncology employees directly.
• Recruiting activities are managed through our Human Resources team.