Director Data Management

Avalo Therapeutics; Philadelphia (Philadelphia County); On-site; USD 180,000 - 240,000; Full time

Job summary

Avalo Therapeutics is seeking a Director of Clinical Data Management to lead data management strategy and execution across its clinical programs. You will oversee CROs and external vendors, ensure data quality and inspection readiness, and support NDA/BLA submissions while collaborating with Regulatory, Biostatistics, and Clinical Operations teams.

The role requires extensive DM experience, CDISC/GCP/ICH knowledge, and proficiency with modern EDC systems.

Qualifications

• Lead and oversee clinical data management across multiple studies.
• Develop data management strategies supporting regulatory submissions.
• Oversee CROs and data management vendors providing deliverables.
• Ensure quality and timely access to trial data.
• Support NDA/BLA/MAA submissions and regulatory filings.

Responsibilities

• Lead data management activities across studies and programs.
• Develop data management strategies aligned with regulatory and business goals.
• Oversee CROs and vendors delivering DM outputs.
• Ensure data quality, integrity, and timely availability for trials.
• Collaborate with Biostatistics, Clinical Ops, Regulatory, and Pharmacovigilance.
• Review key study docs (DM Plans, CRF Design, Data Review Plans).
• Drive RBQM and quality management practices.
• Support inspections and audits.

Skills

Leadership

Data strategy

Collaboration

RBQM

Education

BS/BA in Life Sciences or related field

MS/MA 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 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 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.