- 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
- 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
- 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
- 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
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vp clinical operations - Boston, MA , USA, United States - i-Pharm
Description
Job Title: Vice President, Global Clinical Operations - Oncology Gene TherapyLocation: 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: