Vice President, Data Management

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

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.

• 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.

• 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.

• 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…