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At Avalo (ahh-vah'-low), we are 100% focused on developing treatments for immune-mediated inflammatory diseases with large unmet needs that affect millions worldwide. Our strategy is to develop medicines that target the IL-1β pathway, which is a central driver of the inflammatory process.
We share a commitment to teamwork, passion for science, and dedication to patients suffering from acute and chronic inflammatory disorders. Our collective expertise in discovery, development, and regulatory approvals is evidenced in our strong individual track records of advancing multiple therapeutic programs to successful commercialization.
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
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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 dedicated to developing therapeutics targeting the IL-1β pathway for immune-mediated inflammatory diseases. Avalo is advancing its lead anti-IL-1β monoclonal antibody (mAb) drug candidate, abdakibart, into a phase 3 registrational program in hidradenitis suppurativa (HS), a chronic inflammatory skin condition that affects an estimated 1–4% of the population globally. Avalo is pursuing additional development opportunities in IL-1β driven indications. Avalo is also developing AVTX-010, a long-acting next-generation anti-IL-1β mAb. 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.
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.
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