Director Data Management

Avalo Therapeutics • Chesterbrook, PA

7d

About The Position

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.

Requirements

• 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.

Nice To Haves

• Experience with risk-based quality management (RBQM)

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director