Gene Therapy Clinical Program Lead

Encoded Therapeutics, Inc.; United States; On-site; USD 145,000 - 180,000; Full time

Benefits offered by this job

Comprehensive benefits package

PTO, sick time and holiday pay

Generous Parental Leave program

Pre-tax medical and dependent care

Job summary

Encoded Therapeutics, Inc. is seeking a Clinical Program Manager (Gene Therapy) to lead operational strategy and execution for a novel clinical‑stage program.

You will work with cross‑functional teams and external experts to drive trial planning, site/vendor selection, and startup through CSR completion. The role requires 8+ years in pharma/biotech clinical operations, strong FDA/ICH/GCP knowledge, budgeting acumen, and the ability to manage multiple timelines and vendors across sites, with

Qualifications

• 8+ years pharma/biotech clinical operations experience; gene therapy preferred.
• Bachelor’s degree in a relevant scientific discipline (Master’s/PhD optional).
• Familiar with FDA, ICH, GCP, and clinical trials terminology.
• Experience selecting and managing vendors to performance standards.
• Strong budgeting and expense management skills.

Responsibilities

• Lead end-to-end operational execution of a gene therapy program.
• Develop trial documents: protocols, informed consent forms, brochures, CRFs.
• Identify risks and implement mitigation actions.
• Develop and manage clinical study timelines and budgets.
• Select investigators and build site relationships to meet timelines.
• Support regulatory documents such as INDs and CTAs.
• Oversee Trial Master File and SOP compliance; monitor regulatory adherence.
• Travel as required.

Skills

FDA & ICH Knowledge

Budgeting

Project Management

Vendor Management

Communication Skills

Education

Bachelor’s degree in a relevant scientific discipline

Master’s or PhD (optional)

Tools

Word Processing

Spreadsheet Software

Job description

Encoded Therapeutics, Inc. is seeking a Clinical Program Manager (Gene Therapy) to lead operational strategy and execution for a novel clinical‑stage program.

You will work with cross‑functional teams and external experts to drive trial planning, site/vendor selection, and startup through CSR completion. The role requires 8+ years in pharma/biotech clinical operations, strong FDA/ICH/GCP knowledge, budgeting acumen, and the ability to manage multiple timelines and vendors across sites, with