Sr. Director, Clinical Data Management

Valid8 Financial, Inc.; South San Francisco (CA); Hybrid; USD 240,000 - 280,000; Full time

Benefits offered by this job

Stock options

Performance bonus

401K plan

Job summary

ALX Oncology is seeking a Sr. Director of Clinical Data Management to provide strategic and operational leadership across the development portfolio, delivering high-quality trial data for regulatory submissions.

The role emphasizes hands-on leadership in a lean biotechnolgy environment and requires strong cross-functional partnerships and operational excellence. The ideal candidate will drive scalable processes, oversee EDC platforms, and manage CROs and vendors while aligning with the

Responsibilities

• Lead the Clinical Data Management function by developing and executing strategies, processes, and operational plans that support ALX Oncology's clinical development portfolio and align with the objectives of the Biometrics organization.
• Oversee Clinical Data Management activities across the development portfolio, 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 to ensure high-quality execution and accountability.
• 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.

Job description

Reporting to the VP, Biometrics, the Sr. Director, Clinical Data Management provides strategic and operational leadership for the Clinical Data Management function across ALX Oncology's development portfolio. As the senior data management leader in a lean biotechnology environment, this individual is responsible for establishing a scalable, fit-for-purpose function that delivers high-quality clinical trial data to support development milestones, regulatory submissions, and future portfolio growth. This role requires a leader who can think strategically while remaining hands-on, building effective partnerships and driving operational excellence in a dynamic, resource-focused organization.

Preference will be given to candidates who can regularly work onsite Mondays and Tuesdays as part of the company's hybrid work model.

Key Responsibilities

• Lead the Clinical Data Management function by developing and executing strategies, processes, and operational plans that support ALX Oncology's clinical development portfolio and align with the objectives of the Biometrics organization.
• Oversee Clinical Data Management activities across the development portfolio, 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 to ensure high-quality execution and accountability.
• 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.

Preferred Qualifications

• 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.
• Approximately 12+ years of progressive Clinical Data Management experience within biotechnology, pharmaceutical, or CRO environments, including Phase I-III clinical studies, with 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, with 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.

Compensation

The salary range for this position at our South San Francisco, CA corporate office is $240,000 - $280,000. Additional factors such as academic credentials and relevant experience will influence the actual salary offered. In addition to a competitive market-based salary, ALX Oncology offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package including 401K. Additional information can be found here: https://alxoncology.com/careers/

About ALX Oncology

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-ascension 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 .