Director, Clinical Data Management & Strategy

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

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.