Full-Time

Senior Director

Editas Medicine

Editas Medicine

201-500 employees

Clinical stage genome editing for disease treatment

Biotechnology

Senior, Expert

Cambridge, MA, USA

Required Skills
Communications
Management
Requirements
  • Bachelor's degree in the scientific/healthcare or related field; Master's or Advanced degree preferred
  • A minimum of 12 years (Director) to 15 years (Sr. Director) of professional DM experience in Pharmaceutical, Biotech, or CRO industry
  • Experience in Rare Disease Drug Development and familiarity with gene and/or cell therapy preferred
  • Significant end-to-end, hands-on experience in all aspects of data management
  • Significant experience working with clinical trials
  • Significant experience and extensive knowledge of the complex and interdependent relationships between protocol development, data collection, data review, and cleaning activities, analysis and reporting
  • Significant experience leading data management activities for clinical trials; expert knowledge of DM processes, tools, methodologies and documentation; expert understanding of DM strategy
  • Significant experience with EDC platforms and database design, including Medidata Rave and Oracle Clinical Inform
  • Significant experience of clinical DM outsourcing with full service global CROs and niche providers
  • Knowledge of GCP, FDA, ICH, CDISC, CDASH regulations and guidelines
  • Experience in resource and budget management
  • Experience in regulatory inspections
  • Excellent verbal and written communication skills
Responsibilities
  • Provide leadership and drive strategic direction of Data Management
  • Provide guidance and mentorship to direct reports
  • Develop DM standards and procedures
  • Review/approve DM-related documents (e.g. eCRF and edit check requirements, Clinical Data Management Plan, CRF Completion Guidelines), as applicable
  • Manage DM resources and contracts
  • Drive the selection, collaborations and oversight of CROs and external vendors to ensure efficiency, quality, and consistency for all DM deliverables
  • Develop and maintain expert competencies within Data Management
  • Ensure compliance with regulatory and industry process and quality standards
  • Represent DM in regulatory inspections
  • Collaborate with cross-functional leads to ensure team effectiveness

Editas Medicine stands out as a leader in the field of genomic medicine, leveraging the potential of CRISPR gene editing technology to develop treatments for serious diseases. The company fosters a vibrant culture, encouraging collaboration and resilience among its team of 'Editors', and is committed to manufacturing and commercializing durable, precision genomic medicines. With a robust pipeline of treatments in development, Editas Medicine is not only repairing broken genes but also shaping the future of medicine.

Company Stage

IPO

Total Funding

$884.6M

Headquarters

Cambridge, Massachusetts

Founded

2013

Growth & Insights
Headcount

6 month growth

11%

1 year growth

25%

2 year growth

11%