Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.
Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care.
We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless and a commitment to refusing to stop at “good enough”.
If this sounds like you, keep reading!Role Summary
The Director of Data Management and Systems (DM) is a strategic and operational leader with deep expertise in DM systems and data standards, responsible for scaling processes and ensuring high-quality, regulatory-compliant data delivery across a fast-paced clinical development environment. This role combines hands-on systems knowledge, vendor oversight experience, and the ability to lead cross-functional study teams ensuring high-quality, regulatory-compliant data delivery that supports timely decision-making and submissions.
The Director is also responsible for overseeing end-to-end data management activities across one or more clinical development programs, bringing program-level leadership and operational discipline to ensure consistency, quality, and regulatory compliance across studies.
The ideal candidate brings a balance of hands-on systems knowledge, vendor oversight experience, and program-level leadership, with a proven ability to scale processes in a fast-paced clinical development environment.
Key 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.
Ideal Candidate
- 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.
- 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
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