Director Data Management

Position Summary

The Director Clinical Data Management provides strategic and operational leadership for all clinical data management activities across Avalo's clinical development portfolio. This individual serves as the functional leader for Data Management, responsible for establishing data strategy, overseeing external partners, driving process excellence, and ensuring the delivery of high-quality, inspection-ready clinical data that supports clinical development, regulatory submissions, and business objectives.

Essential Duties and Responsibilities

• Lead and oversee all clinical data management activities across multiple clinical studies and development programs.
• Develop and implement data management strategies that support clinical, regulatory, and business objectives.
• Provide leadership and oversight of CROs and technology vendors responsible for data management deliverables.
• Ensure quality, integrity, consistency, and timely availability of clinical trial data.
• Collaborate closely with Biostatistics, Statistical Programming, Clinical Operations, Clinical Development, Medical Monitoring, Regulatory Affairs, and Pharmacovigilance teams.
• Review and approve key study documentation including:
• Data Management Plans
• Edit Check Specifications
• CRF Design
• Data Review Plans
• Database Build and Validation Documentation
• Drive risk-based data review and quality management practices.
• Support regulatory inspections and audits.
• Contribute to submission readiness activities including NDA, BLA, MAA, and other global regulatory filings.
• Build scalable data management processes, standards, and SOPs as the organization grows.
• Mentor and develop internal team members and consultants

Required Education and Experience

• BS/BA degree in Life Sciences, Engineering, Computer Science, Mathematics, Statistics, or related field; MS/MA degree preferred.
• 12+ (if MS/MA degree) or 15+ (if BS/BA degree) years of clinical data management experience within biotechnology, pharmaceutical, CRO, or related environments.
• 5+ years of people management experience
• Demonstrated experience supporting Phase I–III clinical trials.
• Experience overseeing external data management vendors and CRO partnerships.
• Strong understanding of:
• CDISC standards
• GCP
• ICH Guidelines
• FDA and global regulatory requirements
• Experience with modern EDC systems such as Medidata Rave, Veeva CDMS, Oracle, or equivalent platforms.

Additional Skills, Knowledge, Abilities

• Experience with risk-based quality management (RBQM)

About Avalo Therapeutics

Avalo Therapeutics is a clinical stage biotechnology company fully dedicated to developing therapeutics targeting the IL-1β pathway for immune-mediated inflammatory diseases. Our lead asset, abdakibart, is an anti-IL-1β monoclonal antibody (mAb). Positive topline data was recently reported for abdakibart in a Phase 2 clinical trial in hidradenitis suppurativa (HS). In addition to HS, we’re exploring additional opportunities to make an impact in prevalent indications that have significant remaining unmet needs. We are also advancing AVTX-010, a long-acting next-generation anti-IL-1β mAb designed to extend dosing intervals and build upon the differentiated profile established by abdakibart. For more information about Avalo, please visit www.avalotx.com.

ATTENTION: External Agencies and Placement Firms

A member of the Avalo Human Resources Department will contact an agency directly if an open position is eligible to be sourced from an outside recruiting service. Avalo does not accept unsolicited resumes from employment agencies for any employment opportunity. All agencies/recruiters must have a written agreement/SOW in place with Avalo and prior to submitting any resume or CV.

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