Director, Data Management and Systems

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Apogee Therapeutics

SiteLinkedInTodas as Vagas

51 - 200 funcionários

🧬 Biotecnologia

💊 Farmacêutico

💰 $149.000.000 Series B em 2022-12

Biotechnology • Pharmaceuticals

Apogee Therapeutics é uma empresa de biotecnologia em fase clínica focada no desenvolvimento de novos biológicos para o tratamento de distúrbios inflamatórios e imunológicos. A empresa mira mercados principais em doenças inflamatórias e imunológicas como dermatite atópica, asma, doença pulmonar obstrutiva crônica, esofagite eosinofílica e outras condições relacionadas. A Apogee Therapeutics busca reformular o padrão atual de cuidados ao avançar terapias com anticorpos que visam mecanismos biológicos bem estabelecidos, com potencial para atender questões dermatológicas, respiratórias e gastroenterológicas. A empresa está comprometida em criar um ambiente de trabalho psicologicamente seguro enquanto prioriza opções de tratamento inovadoras para aqueles que vivem com essas condições.

Descrição

• Provide strategic and operational leadership for DM systems (e.g., EDC, ePRO/eCOA, RTSM, CTMS integrations) • Lead selection, implementation, optimization, and governance of DM technologies and platforms to support scalable, high-quality data management across clinical development programs • Champion data standards (e.g., CDISC, SDTM) and metadata-driven approaches • Partner with Biostatistics, Programming, and IT to ensure seamless data flow and interoperability across systems • Evaluate emerging technologies (AI/ML, automation, decentralized trial tools) to enhance data quality and efficiency • Provide strategic leadership and oversight of DM activities across assigned clinical programs (Phases I–III and beyond) • Serve as the DM lead on cross-functional program teams, influencing study design, timelines, and data strategy • Ensure delivery of high-quality, submission-ready datasets in alignment with program milestones • Proactively identify risks to data quality, timelines, or deliverables and implement mitigation strategies • Oversee all DM deliverables including CRF design, database build, data cleaning, coding, and database lock • Establish and maintain data review strategies, including centralized monitoring and risk-based approaches • Ensure compliance with GCP, ICH guidelines, and regulatory requirements (FDA, EMA, etc.) • Drive inspection readiness and support regulatory submissions • Provide strategic oversight of CROs and external data vendors • Define scope, KPIs, and performance metrics; ensure accountability and high-quality deliverables • Build, mentor, and lead a high-performing DM team • Foster a culture of accountability, innovation, and continuous improvement • Provide coaching and career development for team members • Develop and standardize DM processes, SOPs, and best practices • Drive initiatives to improve efficiency, scalability, and data quality • Lead or contribute to cross-functional initiatives related to data strategy and digital transformation.

🎯 Requisitos

• Bachelor’s degree in life sciences, computer science, or related field; advanced degree preferred • 12+ years of experience in clinical data management within biotech, pharma, or CRO environments • Experience in both operational DM and systems/technology implementation • Demonstrated leadership of DM activities across multiple clinical trials and programs • Deep knowledge of EDC systems (e.g., Medidata Rave) • Strong understanding of CDISC standards (SDTM, CDASH) and data lifecycle • Experience with data integrations, external data (labs, imaging, biomarkers), and decentralized trial technologies • Familiarity with data visualization and analytics tools is a plus • Proven ability to lead cross-functional teams and influence at the program level • Strong strategic thinking with hands-on execution capability • Excellent communication and stakeholder management skills • Experience in fast-paced, growing organizations preferred • Ability to bridge systems/technology with clinical execution • Strong ownership mindset over data quality and delivery timelines • Proactive, solutions-oriented approach to complex data challenges • Effective leadership in ambiguity and evolving clinical landscapes.

🏖️ Benefícios

• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless • Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits • We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave • Commitment to growing you professionally and providing access to resources to further your development • Apogee offers regular all team, in-person meetings to build relationships and problem solve