Sr. Director/Head of Data Management

About the role

The Head of Data Management (Senior Director) is a key leadership role in a lean biotech company responsible for establishing and leading the Clinical Data Management function. This role will provide both strategic direction and hands-on execution to ensure high-quality clinical trial data that supports critical development milestones and future regulatory submissions.

Primary responsibilities and duties

• Functional Leadership & Buildout

• Serve as the functional lead for all Clinical Data Management activities across the development portfolio.
• Provide input into Biometrics strategy and implement department initiatives.
• Build fit-for-purpose processes, standards, templates, and governance appropriate for a lean organization.
• Develop a roadmap for scaling the function as programs advance.
• Assess future hiring needs and organizational design as portfolio complexity increases.

• Hands-On Study Execution

• Interface with the project team to ensure that data management services are delivered in a consistent, high-quality manner.
• Provide day-to-day oversight of outsourced data management activities for ongoing clinical studies.
• Review and approve key deliverables including eCRFs, edit checks, data review plans, coding conventions, reconciliation plans, and database lock plans.
• Act as internal escalation point for data issues impacting timelines, quality, or study milestones.
• Lead data review, issue triage, and milestone readiness activities as needed.

• CRO & Vendor Oversight

• Lead management of CROs and specialty vendors providing EDC, eCOA/ePRO, coding, central labs, and related services.
• Establish clear expectations, timelines, governance cadence, and performance metrics.
• Ensure vendors remain aligned to company priorities and operate with urgency.
• Manage budgets and identify cost-efficient solutions without compromising quality.

• Cross-Functional Partnership

• Work closely with Clinical Operations, Biostatistics, Statistical Programming, Clinical Science, Medical, Safety, Regulatory, and Quality team members.
• Support protocol development by advising on data collection strategy, endpoint feasibility, and operational practicality.
• Ensure data readiness for interim analyses, safety reviews, DSMB meetings, and topline readouts.

• Systems & Process Optimization

• Oversee EDC and related data systems selection, configuration strategy, and vendor management.
• Implement streamlined processes that minimize burden while maintaining compliance.
• Introduce dashboards and metrics to improve visibility to study progress and data quality.

• Inspection Readiness & Corporate Support

• Maintain documentation and processes that support diligence reviews, audits, and future inspections.

Educational background, experience, knowledge, skills and abilities

• Education

• Bachelor’s degree in Life Sciences, Statistics, Computer Science, or related discipline required.
• Advanced degree preferred.

• Experience

• 10+ years of clinical data management experience in biotech, pharma, or CRO settings. At least 6 years of overall experience require acting as a project lead data manager.
• Prior leadership experience with responsibility for outsourced studies and vendor oversight.
• Experience in small biotech or resource-focused environments strongly preferred.
• Experience supporting Phase I/II/III studies required; Phase IV and submission experience a plus.
• Experience in Oncology and/or Immuno-oncology trials preferred.

• Technical expertise

• Strong knowledge of EDC systems such as Medidata Rave, Veeva EDC, or Oracle platforms.
• Solid understanding of data cleaning, coding, external data reconciliation, and database lock.
• Familiarity with CDISC standards and submission expectations.
• Strong vendor governance and budget management skills.

• Leadership style

• Hands-on and comfortable working with focused internal teams.
• Practical, solutions-oriented, and able to prioritize effectively.
• Strong communicator who can influence across functions and with external partners.

Salary range

$240,000 - $280,000 DOE

Physical demands

• Ability to communicate in written and oral forms.
• Must be able to interact and communicate in written and oral forms with a diverse group of individuals on both technical and business topics.
• The ability to sit, stand, kneel, stoop, walk, use hands to finger, handle, or feel, point, and reach with hands and arms.
• Must be able to travel 25% of the time without restriction, domestically and/or internationally.
• Must be able to use the telephone and communicate clearly with a host of external individuals, domestically and globally.
• Ability to work at a computer for extensive periods of time.
• Ability to work in a fast-paced working environment managing multiple tasks.

About Alx Oncology

Alx Oncology is a clinical-stage and patient-focused immuno-oncology company developing therapies that block the CD47 myeloid checkpoint pathway. Our lead candidate, Evorpacept (ALX148), is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. Our second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action and potential to be both first and best in class.

For more information about us, please visit www.alxoncology.com.