Director, Data Management and Systems

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Apogee Therapeutics

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51 - 200 Mitarbeiter

🧬 Biotechnologie

💊 Pharmazie

💰 €149.000.000 Series B im 2022-12

Biotechnology • Pharmaceuticals

Apogee Therapeutics ist ein biopharmazeutisches Unternehmen im klinischen Stadium, das sich auf die Entwicklung neuartiger Biologika zur Behandlung von Entzündungs- und Immunerkrankungen konzentriert. Das Unternehmen zielt auf bedeutende Märkte in den Bereichen entzündliche und immunologische Erkrankungen ab, wie z. B. atopische Dermatitis, Asthma, chronisch obstruktive Lungenerkrankung, eosinophile Ösophagitis und andere verwandte Zustände. Apogee Therapeutics strebt an, den aktuellen Behandlungsstandard zu verändern, indem es Antikörpertherapeutika vorantreibt, die auf etablierte biologische Mechanismen abzielen und das Potenzial haben, dermatologische, respiratorische und gastroenterologische Probleme zu adressieren. Das Unternehmen ist dazu verpflichtet, ein psychologisch sicheres Arbeitsumfeld zu schaffen, während es innovative Behandlungsoptionen für Menschen mit diesen Erkrankungen priorisiert.

Beschreibung

• 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.

🎯 Anforderungen

• 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.

🏖️ Vorteile

• 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