Director, Data Management

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

Place in the Organization At uniQure, we are delivering on the promise of gene therapy and delivering hope for patients facing urgent unmet medical needs. Every role in our organization carries profound purpose; whether you're in research, operations, access, or support, your contributions impact patients. We're seeking passionate professionals who thrive in high-stakes environments, uphold rigorous quality standards, and share our relentless commitment to transforming the lives of patients. Join us in making the impossible possible, where your expertise becomes a catalyst for life-changing treatments.

Reporting to VP, Head of Biometrics, this Director, Data Management (DM), will serve as a functional lead across the portfolio and the primary point of contact on DM as an internal subject matter expert (SME). This role will be responsible for not only the oversight of Contractor Research Organization (CRO) vendors to ensure high-quality study level deliverables but also the strategical and operational development of Data Management function at uniQure. The Director, Data Management, joins an established organization that includes both internal team (based in Lexington, MA) and external consultants with deep knowledge of clinical development. This role will closely collaborate with Biostatistics, Statistical Programming, Clinical Operation, Medical and other key clinical development functions in a multidisciplinary and fast-pacing environment.

The ideal candidate brings solid expertise in Data Management area and deep understanding on clinical development. This individual must have a demonstrated ability to partner across organizational lines, excellent communication skills and expertise breadth to lead and navigate all types of complex Data Management topics.

Key Result Areas (major Duties, Accountabilities And Responsibilities)

Data Management

• Lead end-to-end Data Management activities across multiple clinical programs and studies in personal or via CRO oversight.
• Serve as the internal SME to address any question/concerns on Data Management function; monitor Data Management process and develop corresponding SOPs; be responsible for long term functional development strategy; influence and align with senior management
• Serve as Data Management leader in any audit process and regulatory interactions
• Be responsible for budget planning, functional RFPs, and vendor selection

Vendor Management

• Oversee CRO external vendors, establish KPIs, ensuring high quality deliverables and cost optimization aligning with internal standards and program needs
• Be responsible for any relevant governance communications and escalations as needed

Qualifications & Skills

• Advanced degree (Master's or PhD) in life sciences, data science, biostatistics or relevant field
• 10+ years of progressive experience of Data Management in Biotech or Pharmaceutical industry
• Extensive and comprehensive experience in clinical Data Management on data base design, data management plan development and execution, CDISC standards (SDTM, ADaM, etc) and SAS technical skills
• Deep understanding of clinical trial process and clinical development lifecycle including functional knowledge and responsibility on regulatory interactions
• Excellent leadership and communication skills

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant, relevant years of experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from where they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

US Salary Range

$205,000-$265,000 USD

uniQure is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age, disability, genetic information, marital status, veteran or military status, or any other characteristic protected by applicable federal, state, or local laws. If you need assistance or a reasonable accommodation during the application process, please contact [e-mail].

uniQure posts all open positions exclusively on our official Careers page and LinkedIn. We do not recruit through any other job boards, third-party websites, or unsolicited outreach via text or messaging apps. All legitimate communication from uniQure's Talent Acquisition team will come from an @uniqure.com email address. We will never request financial information nor payment of any kind during the application process. If you receive suspicious outreach claiming to be from uniQure, do not respond or share personal information. Inquiries can be made via [e-mail].

uniQure processes personal data submitted through this application for recruitment and hiring purposes only. Depending on your location, you may have specific rights regarding your personal data. For full details on how we collect, use, store, and protect your information - including disclosures for California residents under the CCPA and for applicants under the GDPR - please review our applicant privacy notice.