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Director, Data Management and Systems

4 hours, 4 minutes ago
United States
Full-time
Lead
Database Administrator
Database Administration
GCP
Apply Now
Apogee Therapeutics

Apogee Therapeutics

Apogee Therapeutics, Inc. is a biotechnology company dedicated to developing innovative biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immune diseases with high unmet needs. Their goa...

Biotechnology
1-10
Founded 2022
$169M raised
View All Jobs 20

Description

  • Provide strategic and operational leadership for data management systems including EDC, ePRO/eCOA, RTSM, and CTMS integrations.
  • Lead the selection, implementation, optimization, and governance of data management technologies and platforms.
  • Champion data standards such as CDISC and SDTM and promote metadata-driven approaches.
  • Partner with Biostatistics, Programming, and IT to ensure seamless data flow and system interoperability.
  • Evaluate emerging technologies such as AI/ML, automation, and decentralized trial tools to improve data quality and efficiency.
  • Oversee data management activities across assigned clinical programs and serve as the DM lead on cross-functional study teams.
  • Influence study design, timelines, and data strategy while ensuring submission-ready datasets are delivered on schedule.
  • Oversee CRF design, database build, data cleaning, coding, and database lock.
  • Establish and maintain data review strategies including centralized monitoring and risk-based approaches.
  • Provide strategic oversight of CROs and external data vendors, including scope definition, KPI management, and performance accountability.
  • Build, mentor, and lead a high-performing data management team.
  • Develop and standardize data management processes, SOPs, and best practices while driving continuous improvement initiatives.

Requirements

  • Bachelor’s degree in life sciences, computer science, or a related field; advanced degree preferred.
  • 12+ years of experience in clinical data management within biotech, pharma, or CRO environments.
  • Experience in both operational data management and systems/technology implementation.
  • Demonstrated leadership of data management activities across multiple clinical trials and programs.
  • Deep knowledge of EDC systems, such as Medidata Rave.
  • Strong understanding of CDISC standards, including SDTM and CDASH, and the data lifecycle.
  • Experience with data integrations and external data sources such as labs, imaging, and biomarkers.
  • Experience with decentralized trial technologies.
  • Familiarity with data visualization and analytics tools is a plus.
  • Experience in fast-paced, growing organizations is preferred.
  • Proven ability to lead cross-functional teams and influence at the program level.
  • Excellent communication and stakeholder management skills.

Benefits

  • Anticipated salary range of $215,000 to $245,000 per year.
  • Market-competitive compensation package with base salary, performance bonus, and equity grant opportunities.
  • Health, welfare, and retirement benefits.
  • Three weeks of PTO, plus two one-week company-wide shutdowns each year and dedicated paid sick leave.
  • Commitment to professional growth with access to development resources.
  • Regular all-team, in-person meetings to build relationships and solve problems.
  • Fast-paced, highly dynamic work environment with the opportunity to help shape the culture and company.

Interested in this position?

Apply directly on the company website

Apply Now

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