Director Data Management

• CRF Design

• 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

• 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
• 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.

• Experience with risk-based quality management (RBQM)

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 .

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.

All resumes must be submitted through the appropriate process. Any resumes submitted without an agreement and/or any resumes sent unsolicited through e-mail accounts of Avalo employees will be considered outside of the appropriate process, do not imply or create any obligation on our part, do not impart any restrictions on Avalo with respect to the hiring of any persons whose resumes are so submitted and are not eligible for placement fees.