Associate Director, Data Management

Obsidian Therapeutics

Cambridge, MA, United States
Competitive salary; stock options available; compr...
Hybrid (on-site in bedford or cambridge, ma)
Clinical data management (cdm)
Cdisc standards sdtm/cdash
Database setup and crf design
Obsidian Therapeutics is seeking an Associate Director of Data Management to oversee the clinical data lifecycle for their cell therapy programs. The ideal candidate will possess strong leadership and project management skills, with a focus on ensuring high-quality, regulatory-compliant data throughout clinical studies

Job Summary

  • The role involves leading the entire data lifecycle from study startup to database lock for a first-in-class autologous cell therapy program targeting solid tumors.
  • Candidates will ensure high-quality, regulatory-compliant data adhering to CDISC standards for FDA and EMA submissions while managing external vendors and CROs.
  • The position offers a unique opportunity to join a well-funded clinical company with blue chip investors and an experienced team focused on delivering transformative therapies.

Matching Summary

Match Score: 85

Obsidian Therapeutics is seeking an Associate Director of Data Management to oversee the clinical data lifecycle for their cell therapy programs. The ideal candidate will possess strong leadership and project management skills, with a focus on ensuring high-quality, regulatory-compliant data throughout clinical studies.

Salary

Competitive salary; Stock options available; Comprehensive benefits package

Skills & Requirements

Must-have

  • Clinical Data Management (CDM)
  • CDISC standards SDTM/CDASH
  • Database setup and CRF design
  • Vendor and CRO management
  • ICH-GCP compliance
  • TIL therapy data tracking

Nice-to-have

  • Collaborative team environment
  • Fast-paced adaptability
  • Continuous learning mindset
  • Resilience under pressure
  • Cross-functional partnership

Key Requirements

  • Experience in clinical data management
  • Knowledge of CDISC standards
  • Background in cell or gene therapy
  • Project management skills
  • Regulatory submission experience

Work Rights

Not specified

Tailored Resume

Cover Letter