Director of Data Management

🕒 Outubro 30

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

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Secretome Therapeutics

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2018

🧬 Biotecnologia

🏥 Saúde

💊 Farmacêutico

🔥 Investimento no último ano

💰 $30.000.000 Series A em 2026-05

Biotechnology • Healthcare • Pharmaceuticals

A Secretome Therapeutics é uma empresa de biotecnologia que desenvolve terapias regenerativas derivadas de células progenitoras cardíacas neonatais e de seu secretoma. Seus principais programas — STM-01 (terapia celular neonatal) e STM-2 (produto à base de secretoma) — estão sendo desenvolvidos para insuficiência cardíaca com fração de ejeção preservada (HFpEF) e cardiomiopatia dilatada (DCM). A empresa destaca a variabilidade quase nula entre doadores, o maior rendimento e a maior potência obtidos de fontes neonatais em comparação com células-tronco adultas, além de uma fonte celular ética e não fetal, que permite uma fabricação consistente e escalável. A Secretome conduz ensaios clínicos em estágio inicial e comunica uma política de acesso expandido para uso investigacional.

Descrição

• Lead all clinical data management activities across Secretome's clinical development programs • Develop and implement data management strategies, standards, processes, and best practices • Oversee protocol review, eCRF design, database development, edit check specifications, user acceptance testing, data cleaning, reconciliation, coding, and database lock • Manage CROs, data management vendors, and technology providers to ensure quality deliverables, timelines, and budget compliance • Establish and maintain data governance frameworks for data quality, integrity, traceability, and inspection readiness • Collaborate with Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Pharmacovigilance, Regulatory Affairs, and Quality teams • Drive risk-based data review and quality oversight, including metrics, issue management, and continuous process improvement • Ensure compliance with ICH-GCP, FDA regulations, 21 CFR Part 11, company SOPs, and applicable privacy requirements • Support regulatory inspections, audits, and health authority submissions • Develop and maintain data management SOPs, work instructions, templates, and training materials • Build and lead a high-performing data management function as the company advances its clinical pipeline

🎯 Requisitos

• Bachelor's degree in Life Sciences, Health Sciences, Computer Science, Biostatistics, Health Informatics, or a related discipline • 8+ years of progressive clinical data management experience within biotechnology, pharmaceutical, or CRO environments • Demonstrated leadership of clinical programs and external data management vendors • Strong expertise in EDC systems, database design, data review, coding, reconciliation processes, and database lock activities • Working knowledge of CDISC standards, MedDRA, and WHODrug • Thorough understanding of ICH-GCP, FDA regulations, data integrity principles, and clinical trial data standards • Excellent project management, communication, and organizational skills • Ability to thrive in a fast-paced, high-growth biotechnology environment • Advanced degree (MS, MPH, PharmD, or equivalent) preferred • Certified Clinical Data Manager (CCDM) certification preferred • Experience supporting biologics, cell therapy, regenerative medicine, cardiovascular, or rare disease programs preferred • Experience leading data management activities through regulatory submissions and inspections preferred • Experience building or scaling data management capabilities within an emerging biotech company preferred

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