VP Clinical Operations - Boston, United States - iPharm

Description

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.
#J-18808-Ljbffr