Vice President, Data Management (US)

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 https://Prilenia.com .

About the role

The Vice President, Data Management, Chief Data Scientist 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:

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 data 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.

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 role.

Direct experience leading data management through at least one successful NDA, BLA, or MAA submission, including database lock and submission data package delivery.

Deep working knowledge of CDISC standards (CDASH, SDTM, ADaM) and experience ensuring submission-ready datasets.

Hands-on experience with major EDC/CDMS platforms (e.g., Medidata Rave, Veeva Vault CDMS, Oracle InForm/Clinical One).

Strong knowledge of FDA regulations, ICH-GCP, and 21 CFR Part 11 as applied to clinical data management.

Demonstrated success managing CROs and data management vendors, including budget and timeline accountability.

Experience supporting or leading through an FDA pre-approval inspection or comparable regulatory audit.

Excellent written and verbal communication skills, with experience presenting to senior leadership and interacting with regulatory agencies.

Skills:

Experience in a small and/or mid-size clinical-stage biotech environment, including building a data management function, including direct experience in US marketing authorization submission.

Therapeutic area experience relevant to Prilenia’s pipeline (e.g., neurology, rare disease, CNS).

Experience with risk-based quality management (RBQM) and centralized statistical monitoring approaches.

Excellent knowledge of regulatory frameworks and requirements for data management including but not limited to FDA and EMA.

Familiarity with real-world data sources, patient registries, or external control arms.

Excellent communication skills, both written and verbal.

Proficient in EDC/CDMS platforms.

Familiarity with the evolving role of AI and Computational Science as it relates to clinical and regulatory activities.

Strong analytical and problem-solving abilities.

Ability to work independently and collaboratively in a team environment.

Strong attention to detail.

Ability to meet deadlines and work under pressure.

Highly organized and self-motivated.

Flexibility to adapt to changing priorities and tasks.

Ability to work effectively in a global collaborative team environment.

Strong interpersonal skills and the ability to build relationships.