Gene Therapy Clinical Program Lead

Encoded Therapeutics; United States; Remote; USD 160,000 - 180,000; Full time

Benefits offered by this job

Comprehensive benefits package

Stock option grants

PTO, sick time and holiday pay

Parental Leave program

Pre-tax medical and dependent care

STD, LTD, Life and AD&D

Professional development opportunities

Team-building events

Fully stocked micro-kitchen

Fitness center at South San Francisco

Job summary

Encoded Therapeutics is seeking a Clinical Program Manager to lead operational strategy for a novel gene therapy program. You will drive trial planning, protocol development, site and vendor selection, and study startup in collaboration with cross-functional teams and external experts.

You will manage timelines, budgets, and regulatory documents, while ensuring study data integrity and adherence to GCP. Extensive travel may be required as part of global clinical operations.

Qualifications

• Bachelor’s degree in a relevant scientific discipline or equivalent.
• 8+ years pharma/biotech clinical operations experience with end-to-end trial management.
• Gene therapy experience strongly preferred.
• Proven ability to develop protocols, informed consent forms, and investigator brochures.
• Deep knowledge of FDA/ICH guidelines and GCP compliance.
• Excellent project management, budgeting, and vendor management skills.
• Outstanding written and spoken communication; cross-functional collaboration.

Responsibilities

• Lead operational strategy and execution for a novel gene therapy program.
• Oversee protocol development, site and vendor selection, and study startup.
• Develop timelines and budgets; manage cross-functional trial teams.
• Ensure regulatory documents and Trial Master File are maintained.
• Monitor compliance with SOPs and regulatory requirements.
• Collaborate with data management and clinical operations partners.
• Travel internationally and domestically as required.
• Provide leadership and mentorship to contract Clinical Operations personnel.

Skills

End-to-end clinical operations

Trial planning

Budget management

Vendor management

Site management

Regulatory documentation

GCP/ICH/FDA knowledge

Project management

Cross-functional leadership

Strong written/verbal communication

Education

Bachelor’s degree in a relevant scientific discipline

Master’s degree

PhD

Tools

MS Word

MS Excel

Databases

Job description

Encoded Therapeutics is seeking a Clinical Program Manager to lead operational strategy for a novel gene therapy program. You will drive trial planning, protocol development, site and vendor selection, and study startup in collaboration with cross-functional teams and external experts.

You will manage timelines, budgets, and regulatory documents, while ensuring study data integrity and adherence to GCP. Extensive travel may be required as part of global clinical operations.