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.
Desired Skills and Experience Job Title: Vice President of Clinical Operations
Location: Boston, MA
Overview: The VP of Clinical Operations will provide strategic leadership and oversight for all clinical operations activities related to the company's gene therapy programs targeting rare forms of oncology in pediatric populations. Based in Boston, this role will be responsible for ensuring the successful execution of clinical trials, from start-up through completion, across multiple sites and regions. The ideal candidate will have extensive experience in managing global clinical operations for gene therapy or other complex biological products, with a deep understanding of regulatory requirements and industry best practices, particularly in the area of pediatric oncology.
Key Responsibilities:
Develop and implement global clinical operations strategies and operational plans for the company's gene therapy programs in rare pediatric oncology indications, ensuring alignment with overall corporate goals and timelines. Manage and oversee the activities of clinical operations teams, including clinical trial management, site selection and management (with expertise in pediatric oncology sites), data management, and clinical supply chain. Collaborate closely with cross-functional teams, including Clinical Development, Regulatory Affairs, Quality Assurance, and other departments, to ensure seamless integration and coordination of clinical activities. Establish and maintain effective partnerships with contract research organizations (CROs), investigator sites (with expertise in pediatric oncology), and other external vendors involved in clinical trials. Ensure compliance with Good Clinical Practice (GCP) guidelines, regulatory requirements, and internal standard operating procedures (SOPs) across all clinical operations activities, with a focus on pediatric oncology studies. Oversee the development and implementation of clinical operations processes, tools, and systems to enhance operational efficiency and quality, tailored to the unique needs of pediatric oncology trials. Monitor and report on clinical operations performance metrics, timelines, and budgets, identifying and addressing potential risks or issues specific to pediatric oncology studies. Represent the company at relevant industry conferences, meetings, and external forums related to clinical operations, gene therapy development, and pediatric oncology. Contribute to the development of regulatory submissions and interactions with health authorities, particularly for pediatric oncology indications. Qualifications:
Advanced degree (Ph.D., Pharm.D., or equivalent) in a scientific or healthcare-related field, or an equivalent combination of education and experience. Minimum of 10 years of progressive clinical operations experience in the biopharmaceutical or biotechnology industry, with at least 5 years in a leadership role overseeing global clinical trials, preferably with experience in pediatric oncology studies. Proven experience in managing clinical operations for gene therapy or other complex biological products, ideally in the pediatric oncology therapeutic area. Comprehensive knowledge of Good Clinical Practice (GCP) guidelines, regulatory requirements, and industry best practices related to clinical operations, gene therapy development, and pediatric oncology studies. Strong leadership, strategic thinking, and problem-solving abilities, with excellent organizational and project management skills. Effective communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external stakeholders, including pediatric oncology experts and patient advocacy groups. Demonstrated experience in leading and managing clinical operations teams, as well as managing relationships with CROs, investigator sites (with expertise in pediatric oncology), and other vendors. Proficiency in relevant clinical operations systems and technologies, including those