Vice President, Data Management (US)

About this role

About Prilenia

Prilenia, a private biopharmaceutical company with a highly committed and talented global team, is seeking a Vice President, Data Management in the US.

Prilenia has a simple but urgent mission - to bring transformative medicines to people affected by devastating neurodegenerative diseases. Unwavering in our commitment to scientific excellence, Prilenia is developing pridopidine, a potent and selective sigma-1 receptor (S1R) agonist investigational therapy, which stimulates key neuroprotective mechanisms impaired in neurodegenerative diseases such as ALS and Huntington’s disease (HD). Prilenia, along with its partner Ferrer, has commenced, in 2026, two pivotal late-stage trials to support potential approval globally in ALS and in HD.

To learn more about our story and company culture, visit us at

About the role

The Vice President, Data Management, Chief Data Scientis will lead the strategy, build-out, and execution of clinical data management across the company’s clinical development portfolio, with direct responsibility for ensuring that data supporting the company’s marketing authorization applications globally are complete, accurate, consistent, and submission-ready. This role owns data management planning, electronic data capture (EDC) systems, data standards (CDISC/SDTM/ADaM), database lock, and CRO/vendor oversight, and partners closely with Biostatistics, Clinical Operations, Regulatory Affairs, Pharmacovigilance, and Quality to ensure the clinical database will withstand Regulatory Authority scrutiny , including pre-approval inspection. The VP will build and lead a fit-for-purpose data management team (internal staff and/or outsourced functions) and establish the SOPs, systems, and governance needed to scale as the company advances toward and beyond potential approval.

Responsibilities:

Strategic Leadership & NDA Readiness

• Serve as the senior data management leader and subject matter expert for all data management, supporting the company’s preparations for marketing authorization applications globally.

• Collaborate with the Chief Data Protection Officer to ensure overall date integrity and compliance globally.

• Develop and execute the clinical data management strategy across ongoing and planned trials, aligned with the company’s regulatory timeline and submission milestones.

• Own end-to-end database lock planning and execution for pivotal trials, ensuring on-time, audit-ready locks that support statistical analysis and NDA filing timelines.

• Represent data management in FDA interactions (e.g., Type B/C meetings, briefing document preparation) and any other relevant meetings with other Regulatory Authorities, and respond to information requests during regulatory review.

• Partner with Regulatory Affairs and Biostatistics to ensure the submission data package (SDTM, ADaM, define.xml, reviewer’s guides) meets FDA Technical Rejection Criteria and current CDISC standards, and any other relevant regulations.

Data Management Operations

• Oversee development of Data Management Plans (DMPs), CRF/eCRF design, edit check specifications, and data validation plans for all studies.

• Ensure timely and high-quality data cleaning, query management, SAE reconciliation, and coding (MedDRA, WHO-DD) across all active protocols.

• Establish and monitor key data quality metrics (query rates, query aging, data entry lag, protocol deviations affecting data) and drive continuous improvement.

• Oversee external data reconciliation (central lab, ECG, imaging, ePRO/eCOA, IRT/IWRS) and third-party data integration.

Systems, Standards & Technology

• Ensure company-wide adherence to CDISC standards (CDASH, SDTM, ADaM) and maintain a standards governance process across studies and vendors.

• Partner with IT and other relevant functions to ensure relevant systems and processes comply with 21 CFR Part 11, GDPR/HIPAA as applicable, and company data privacy and information security policies.

Vendor & CRO Oversight

• Manage relationships with data management CROs, EDC vendors, and specialty data vendors, including scope, budget, timelines, and quality oversight via service level agreements and metrics.

• Lead vendor selection (RFP process, bid defense) for data management services and systems as the portfolio scales.

• In collaboration with Quality, conduct or oversee relevant vendor audits and ensure timely resolution of findings related to data management deliverables.

Quality, Compliance & Inspection Readiness

• Ensure data management practices comply with ICH-GCP, FDA regulations, and company SOPs; maintain inspection-ready documentation (Trial Master File data management sections, audit trails, data management plans).

• Lead data management readiness for regulatory authorities (including FDA) pre-approval inspections (PAI) and sponsor audits, including mock inspections and CAPA management.

• Review for completeness and maintain data management SOPs, working practices, and training materials; ensure staff and vendor training compliance.

Team Leadership & Cross-Functional Collaboration

• Manage a hybrid internal/outsourced model, appropriate to the size and stage currently of Prilenia.

• Partner closely with Biostatistics and Statistical Programming on analysis-ready data timelines, and with Clinical Operations on site-level data quality and monitoring plans.

• Manage the data management function’s budget, resourcing, and vendor spend; report progress and risks to senior leadership and, as appropriate, the Board.

• Contribute and serve as data management SME in cross-functional, alliance management and BD activities, as may be required from time to time.

Qualifications:

• Advanced degree in life sciences, health informatics, statistics, computer science, or a related field; advanced degree preferred.

• 12+ years of progressive clinical data management experience in the pharmaceutical, biotechnology, or CRO industry, including 5+ years in a senior leadership…