Director, Data Management — Clinical Data Strategy

uniQure; Lexington (MA); On-site; USD 205,000 - 265,000; Full time

Job summary

uniQure in Lexington, MA, seeks a Director of Data Management to lead end-to-end DM activities across multiple programs, oversee CRO vendors, and drive functional development with senior management. You will partner with Biostatistics, Clinical Operations, and Medical teams in a fast-paced, regulated environment.

The ideal candidate combines an advanced life sciences degree with 10+ years in biotech or pharma DM, strong leadership, and in-depth knowledge of CDISC SDTM/ADaM and SAS, plus

Qualifications

• Advanced degree (Master's or PhD) in life sciences, data science, biostatistics or relevant field
• 10+ years of progressive Data Management experience in Biotech or Pharmaceutical industry
• Deep experience in clinical Data Management: database design, data management plans, CDISC SDTM/ADaM, SAS
• Solid understanding of clinical trial process and regulatory interactions
• Strong leadership and communication skills

Responsibilities

• Lead end-to-end Data Management activities across multiple clinical programs and studies, including CRO oversight
• Serve as internal SME to address Data Management questions, monitor processes, and develop SOPs
• Lead Data Management in audits and regulatory interactions
• Oversee budget planning, functional RFPs, and vendor selection

Skills

Leadership

Communication

Vendor Management

SAS

CDISC SDTM/ADaM

Education

Advanced degree (Master's or PhD)

Tools

SAS

CDISC Standards

Job description

uniQure in Lexington, MA, seeks a Director of Data Management to lead end-to-end DM activities across multiple programs, oversee CRO vendors, and drive functional development with senior management. You will partner with Biostatistics, Clinical Operations, and Medical teams in a fast-paced, regulated environment.

The ideal candidate combines an advanced life sciences degree with 10+ years in biotech or pharma DM, strong leadership, and in-depth knowledge of CDISC SDTM/ADaM and SAS, plus