Vice President, Data Management (US)

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 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 roll 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