Director Data Management

Avalo Therapeutics; Chesterbrook (PA); On-site; USD 120,000 - 160,000; Full time

Job summary

Avalo Therapeutics is seeking a Director of Clinical Data Management to provide leadership for data management in clinical development. You will oversee activities across multiple studies, ensuring the quality and integrity of clinical trial data.

The ideal candidate will have significant experience in clinical data management, particularly within biotechnology or pharmaceutical environments, and demonstrate a strong understanding of regulatory requirements.

Qualifications

• 12+ years of clinical data management experience with MS/MA or 15+ with BS/BA.
• 5+ years of people management experience.
• Experience with oversight of external data management vendors.

Responsibilities

• Lead and oversee clinical data management activities across multiple studies.
• Develop and implement data management strategies.
• Ensure quality, integrity, and timely availability of clinical trial data.

Skills

Clinical data management

Phase I–III clinical trials

People management

GCP

Risk-based quality management (RBQM)

Education

BS/BA degree in Life Sciences, Engineering, Computer Science, Mathematics, or Statistics

MS/MA degree preferred

Tools

Medidata Rave

Veeva CDMS

Oracle

Job description

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 PlansDatabase 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 IL-1β-based treatments for immune-mediated inflammatory diseases. Our lead asset, AVTX-009, is in a Phase 2 clinical trial for hidradenitis suppurativa (HS). We’re also exploring additional opportunities to make an impact in prevalent indications that have significant remaining unmet needs. For more information about Avalo, please visit www.avalotx.com.