Full-Time

Director – Clinical Operations

Posted on 5/7/2024

Vor Bio

Vor Bio

51-200 employees

Developing cell therapies for blood cancers

Biotechnology

Senior, Expert

Cambridge, MA, USA

Required Skills
Communications
Management
Requirements
  • Minimum of BA/BS with a minimum of 8 years of clinical trial and clinical program experience
  • Experience with Cell and Gene Therapy is highly desirable and 4+ years Phase 1-3 experience in Oncology is required
  • Robust experience in early and late phase global drug development
  • Multi-dimensional Clinical Operations background with capability of devising plans for operational challenges
  • Cross-collaboration proficiency with other functions such as Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management, etc.
  • Advanced working knowledge of current FDA, ICH, GCP regulations and guidelines
  • Experience in GCP inspections/audits
  • Outstanding verbal and written communication skills
  • Proven track record of effective leadership and team-building skills in the biotech or pharmaceutical industry
  • Resilient, creative, capable problem-solver
  • Excellent organizational skills and ability to work independently
  • Experience in establishing and maintaining relationships with key opinion leaders
  • Ability and willingness to travel up to 20%
Responsibilities
  • Executes the day-to-day operations of clinical trials from the protocol concept through the clinical study report
  • Develops and manages comprehensive trial timelines and metrics
  • Ensure that clinical trials are properly resourced, managed and executed within budget and in accordance with established timelines and quality standards
  • Develop and manage trial budget(s) and maintain within financial goals
  • Drive selection, management and oversight of external vendors
  • Lead the identification and management of third-party Clinical Operations vendors
  • Perform and document trial level Sponsor Oversight of outsourced clinical activities
  • Manage invoice and budget tracking for individual trials
  • Review and provide functional input into relevant clinical documents
  • Prioritize day-to-day issues and Corporate/Clinical goals
  • Provide real-time updates to Senior Management and cross-functional teams
  • Oversee/collaborate on and contribute to inspection readiness activities
  • Coordinate activities related to audit findings and/or identification of significant site noncompliance
  • Develop relationships with Key Opinion Leaders
  • Coach and provide guidance to Clinical Operations team
  • Train and mentor junior staff on Clinical Operations processes
  • Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs
  • Strive for continuous improvement and more efficient ways of working within the Clinical team
  • May serve as subject matter expert (SME) in one or more areas

Vor Bio is dedicated to transforming the treatment of blood cancers through a combination of advanced Hematopoietic Stem Cell biology, genome engineering, and CAR-T cell technology. By focusing on making healthy cells resistant to targeted therapies, this company offers a unique workplace for those passionate about cutting-edge healthcare solutions. Its strong commitment to research and development in oncology positions it as a leader in the industry, providing employees with the opportunity to be at the forefront of medical science and contribute to significant advancements in patient care.

Company Stage

IPO

Total Funding

$267.8M

Headquarters

Cambridge, Massachusetts

Founded

2015

Growth & Insights
Headcount

6 month growth

4%

1 year growth

14%

2 year growth

34%