Lead Clinical Program Manager, Gene Therapy Trials

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

Benefits offered by this job

Comprehensive benefits

Stock options

PTO/ holidays

Parental leave

Pre-tax benefits

On-site fitness center

Job summary

Encoded Therapeutics is seeking a Clinical Program Manager to lead operational strategy and execution for a gene therapy program.

You will collaborate with Medical Monitor and cross-functional teams to drive trial planning, site and vendor selection, and startup activities, ensuring alignment with regulatory requirements. The role demands strong program management, budgeting, and communication skills.

Qualifications

• 8+ years pharma/biotech clinical operations experience.
• End-to-end trial management with gene therapy experience preferred.
• Strong FDA/ICH GCP knowledge and regulatory understanding.
• Excellent written and verbal communication skills.
• Self-motivated with attention to detail.

Responsibilities

• Lead operational strategy and execution for a gene therapy program.
• Develop documents for studies: protocols, ICFs, brochures, CRFs, manuals.
• Identify risks and implement mitigation strategies.
• Develop and manage study timelines and budgets.
• Select study investigators and evaluate adequacy to perform research and meet timelines.
• Build relationships with clinical sites and manage enrollment.
• Contribute to regulatory documents like INDs and CTAs.
• Oversee Trial Master File maintenance and data review.

Skills

FDA/ICH

GCP knowledge

Project management

Budget management

Vendor management

Cross-functional leadership

Documentation/writing

Communication

Education

Bachelor in science

Tools

MS Word

MS Excel

Databases

Presentations

Job description

Encoded Therapeutics is seeking a Clinical Program Manager to lead operational strategy and execution for a gene therapy program.

You will collaborate with Medical Monitor and cross-functional teams to drive trial planning, site and vendor selection, and startup activities, ensuring alignment with regulatory requirements. The role demands strong program management, budgeting, and communication skills.