Clinical Program Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the operational strategy and implementation for an innovative clinical-stage gene therapy program.

• Manage the complete operational execution from the concept of the protocol to the completion of the Clinical Study Report.

• Facilitate cross-functional alignment, manage trial budgets, and oversee project timelines.

• Create clinical study documents and procedures, including protocols, informed consent forms, investigator brochures, case report forms, and study procedure manuals.

• Identify and analyze risks while implementing strategies for mitigation and corrective actions.

• Develop and manage timelines and budgets for clinical studies.

• Select study investigators and assess their research capabilities and adherence to timelines.

• Cultivate relationships with clinical sites and manage studies to achieve enrollment targets.

• Contribute to INDs, CTAs, and other regulatory documentation.

• Conduct oversight monitoring activities as necessary.

• Collaborate with data management colleagues to lead study data review processes.

• Oversee the ongoing maintenance of the Trial Master File.

• Contribute to the preparation of clinical study reports.

• Ensure compliance with company SOPs, GCP, FDA regulations, and applicable international standards.

• Design and implement Study Management plans and processes.

• Represent clinical operations in cross-functional initiatives and act on behalf of the team as needed.

• Provide direct line management, supervision, and operational guidance to contract Clinical Operations staff.

• Report to the Senior Director of Clinical Operations.

⛳️ Requirements

• At least 8 years of clinical operations experience in pharma/biotech with a Bachelor’s degree in a relevant scientific field or equivalent (6 years with a Master’s, or 3 years with a PhD).

• Proven track record in managing complex clinical trials from start to finish; experience in gene therapy is highly preferred.

• Comprehensive knowledge and understanding of FDA and ICH Guidelines, Good Clinical Practices (GCP), medical terminology, and clinical trials.

• Detailed insight into clinical protocol design, implementation, and the overall drug development process.

• Exceptional project management skills.

• Proven history of successfully selecting and managing vendors based on performance standards.

• Strong financial skills, including budget creation and expense management.

• Proficient in word processing, spreadsheet, database, presentation, and filing (archiving) systems.

• Demonstrated problem-solving capabilities and excellent organizational skills.

• Exceptional written communication skills, including the ability to write technical trial documents.

• Self-motivated with the ability to prioritize, manage a high volume of work, and pay attention to detail.

• Strong interpersonal and collaborative abilities.

• Excellent verbal and written communication skills.

• Willingness to travel internationally and domestically as required.

🏝️ Benefits

• Comprehensive benefits package, featuring competitive employer premium contributions.

• Significant stock option grants.

• Paid time off, sick leave, and holiday pay.

• Generous Parental Leave program.

• Pre-tax medical and dependent care programs.

• Short-term disability (STD), long-term disability (LTD), life insurance, and accidental death & dismemberment (AD&D) coverage.

• Opportunities for professional development.

• Team-building events.

• Fully stocked micro-kitchen.

• Fitness center available at the South San Francisco location.

• Discretionary annual bonus.

• Discretionary stock-based long-term incentives.