Apogee Therapeutics - Director, Data Management and Systems
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Requirements
• 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. • Technical Expertise • 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. • Leadership & Competencies • 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. • The anticipated salary range for candidates for this role will be $215,000 - $245,000/year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.
Responsibilities
• Systems & Technology Leadership • 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. • Program & Study Leadership • 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. • Data Management Operations • 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. • Vendor & Partner Oversight • Provide strategic oversight of CROs and external data vendors. • Define scope, KPIs, and performance metrics; ensure accountability and high-quality deliverables. • Lead vendor selection and contract input for DM-related services. • People Leadership & Development • 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. • Process Improvement & Innovation • 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.
Benefits
• 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 • E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster.
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