Head of Clinical Operations

at  Ensoma

We are seeking an experienced, collaborative, and motivated individual to serve as Head of Clinical Operations for Ensoma’s gene therapy programs. This role offers an opportunity for a versatile leader with deep clinical operations expertise to become an integral member of the Ensoma team. You will be responsible for establishing and leading a world-class clinical operations function to conduct industry-leading gene therapy clinical trials across Ensoma’s portfolio. This impactful role is an opportunity to build a function, shape the development of Ensoma’s in vivo therapies, and ultimately enable a better future for patients.

QUALIFICATIONS:

Required:

• A Bachelor’s Degree with at least ten years of Clinical Operations experience in the biopharmaceutical industry
• A thorough understanding of clinical trial processes, including clinical project management, site management, clinical supply, medical writing, data management, and data analysis
• A strong and current knowledge of Good Clinical Practices (GCPs), including ICH, FDA, EMA, and other relevant guidelines
• A prior track record of success in developing and maintaining successful relationships with external partners
• Previous experience with regulatory filings (INDs, CTAs, etc.) with various health authorities (FDA, EMA, etc.)
• Strong leadership capabilities, including excellent communication, presentation, problem-solving, and interpersonal skills; demonstrated ability to succeed in a matrixed environment and lead by influence
• Domain expertise in rare disease drug development and trial recruitment
• Willingness and ability to travel domestically and internationally (up to 20%)

Preferred:

• Prior experience working in advanced therapies (i.e., cell or gene therapy)
• Prior experience with early-stage clinical trials
• Prior experience establishing a Clinical Operations function in a small to mid-size biopharmaceutical company

• Design and build the clinical operations function, including staffing, systems, procedures, and external collaborations
• Establish strong relationships with investigators and clinical site staff; oversee site feasibility assessment, qualification, contracting, and performance management
• Identify, select, and manage contract research organizations and clinical vendors as needed
• Contribute to study and program documents, including clinical protocols, consent forms, case report forms, governance charters, study reports, clinical development plans, and regulatory documents
• Build and track timelines, budgets, milestones, and risk-management plans; partner with the finance team to estimate trial costs and support long-range planning
• Partner with the quality team to ensure compliance and audit-readiness in accordance with all applicable standards and guidelines
• Work collaboratively across functions, in the program team environment, and as a member of the leadership team to achieve corporate goals