VP Clinical Operations

BBBH35356_1712165399
  • Boston, Massachusetts
  • Permanent

Job Title: Vice President, Global Clinical Operations - Oncology Gene Therapy

Location: Boston, MA (Willingness to travel domestically and internationally required)

Overview: Lead the global clinical operations function for this clinical-stage gene therapy biotech focused in oncology. Provide strategic oversight and ensure successful execution of gene therapy clinical trials (Phase I-IV) across regions. Collaborate with cross-functional teams to align studies with program goals, timelines, budgets and quality standards, with a focus on oncology indications.

Strategic Responsibilities:

  • Develop and implement operational strategies for global gene therapy clinical operations
  • Establish vision and objectives for the oncology gene therapy trials function
  • Foster culture of innovation tailored to complex gene therapy studies
  • Represent company at oncology, gene therapy and clinical operations events

Tactical Responsibilities:

  • Oversee execution of oncology gene therapy trials adhering to GCP, regulatory requirements and SOPs
  • Ensure quality processes and systems tailored to gene therapy studies
  • Collaborate with oncology scientific/medical teams, regulatory, manufacturing
  • Allocate resources effectively, manage budgets and mitigate risks
  • Drive continuous compliance with evolving gene therapy regulations

Leadership:

  • Lead and mentor clinical operations team focused on gene therapy trials
  • Promote company values and provide gene therapy/oncology training
  • Attract, develop and retain talent experienced in gene therapy development

Qualifications:

  • Bachelor's in scientific/medical field (advanced degree in genetics/gene therapy preferred)
  • 15+ years clinical operations experience in biotech, including gene therapy studies
  • Significant experience in oncology clinical trials required
  • Prior leadership roles managing global gene therapy studies
  • Deep expertise in gene therapy regulations and guidelines
  • Proven track record leading oncology gene therapy IND/BLA submissions
  • Collaborative experience across functions for oncology programs
  • Strategic mindset and ability to optimize gene therapy trial operations
  • Exceptional communication skills for patient advocacy and site management

This strategic role will lead clinical operations for pioneering oncology gene therapies. Oncology and gene therapy expertise, including regulations, study operations and cross-functional collaboration, is essential.

Nicole Crowley Senior Consultant

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