Vice President, Data Management

🕒 Outubro 5

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🔴 Especialista

👔 Vice-presidente

👻 Score fantasma 12%

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Prilenia

SiteLinkedInTodas as Vagas

11 - 50 funcionários

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

💰 $43.000.000 Series B em 2021-11

Healthcare • Biotechnology • Pharmaceuticals

A Prilenia é dedicada ao desenvolvimento de novos tratamentos para pacientes e famílias que enfrentam doenças neurodegenerativas e distúrbios do neurodesenvolvimento, como a doença de Huntington e esclerose lateral amiotrófica (ELA). Eles se concentram em aproveitar as capacidades neuroprotetoras do cérebro, particularmente através da ativação do receptor sigma-1 (S1R), para restaurar vias prejudicadas no cérebro. A Prilenia está avançando na pesquisa científica e explorando potenciais tratamentos para proporcionar esperança e melhorar a vida dos pacientes e suas famílias.

Descrição

• Lead the strategy, build-out, and execution of clinical data management across the company’s clinical development portfolio • Ensure data supporting global marketing authorization applications are complete, accurate, consistent, and submission-ready • Own data management planning, EDC systems, data standards, database lock, and CRO/vendor oversight • Build and lead a fit-for-purpose data management team and establish SOPs, systems, and governance • Serve as senior data management leader and subject matter expert for marketing authorization application preparations • Develop and execute clinical data management strategy across ongoing and planned trials • Lead end-to-end database lock planning and execution for pivotal trials • Represent data management in FDA and other regulatory authority interactions and respond to regulatory review information requests • Partner with Regulatory Affairs and Biostatistics on submission data packages, including SDTM, ADaM, define.xml, and reviewer’s guides • Oversee Data Management Plans, CRF/eCRF design, edit check specifications, and data validation plans • Ensure data cleaning, query management, SAE reconciliation, coding, external data reconciliation, and third-party data integration • Establish and monitor data quality metrics and drive continuous improvement • Ensure adherence to CDISC standards and compliance with 21 CFR Part 11, GDPR/HIPAA, and data privacy and security policies • Manage CRO, EDC vendor, and specialty data vendor relationships, including scope, budget, timelines, and quality oversight • Lead vendor selection and oversee vendor audits and resolution of findings • Ensure compliance with ICH-GCP, FDA regulations, and company SOPs; maintain inspection-ready documentation • Lead readiness for pre-approval inspections and sponsor audits, including mock inspections and CAPA management • Maintain SOPs, working practices, training materials, and training compliance • Manage hybrid internal/outsourced operating model, function budget, resourcing, and vendor spend • Partner with Biostatistics, Statistical Programming, Clinical Operations, Quality, Regulatory Affairs, Pharmacovigilance, and other functions • Report progress and risks to senior leadership and, as appropriate, the Board • Contribute as data management subject matter expert in cross-functional, alliance management, and business development activities

🎯 Requisitos

• 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 such as Medidata Rave, Veeva Vault CDMS, and 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 • Experience in a small and/or mid-size clinical-stage biotech environment, including building a data management function and direct experience in US marketing authorization submission • Therapeutic area experience relevant to Prilenia’s pipeline, such as neurology, rare disease, or CNS • Experience with risk-based quality management (RBQM) and centralized statistical monitoring approaches • Excellent knowledge of regulatory frameworks and requirements for data management, including FDA and EMA • Familiarity with real-world data sources, patient registries, or external control arms • Proficient in EDC/CDMS platforms • Familiarity with the evolving role of AI and Computational Science as it relates to clinical and regulatory activities • Excellent written and verbal communication skills, strong analytical and problem-solving abilities, strong attention to detail, ability to work independently and collaboratively, ability to meet deadlines and work under pressure, highly organized and self-motivated, flexibility to adapt to changing priorities, ability to work effectively in a global collaborative team environment, and strong interpersonal skills

🏖️ Benefícios

• Full-time remote position • Flexible schedule • Equal opportunity employment • Diverse, inclusive, and welcoming workplace • Up to 15% travel including CRO and site visits, investigator meetings, and regulatory interactions