Clinical Program Manager

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 Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visitwww.Encoded.com.

Reporting to the Senior Director of Clinical Operations, the Clinical Program Manager will be responsible for leading the operational strategy and execution for a novel clinical-stage gene therapy program. Working with the Medical Monitor, cross-functional trial teams, and external experts, the CPM will drive clinical trial planning, protocol development, site and vendor selection, and study startup to support corporate development goals.

The specific responsibilities of this position include:

• Accountable for end-to-end operational execution of a novel gene therapy clinical program, managing cross-functional alignment, trial budgets, and project timelines from protocol concept through to Clinical Study Report (CSR) completion.

• Develop documents and procedures required to conduct clinical studies, including protocols, informed consent forms, investigator brochures, case report forms, study procedure manuals.
• Identify and interpret risks, and implement mitigation strategies/corrective actions to address them
• Develop and manage clinical study timelines consistent with the company’s goals
• Develop and manage study budgets
• Select study investigators and evaluate adequacy to perform research and meet study timelines.
• Build relationships with clinical sites
• Managing studies to meet enrollment goals
• Contribute to development of key regulatory documents such as INDs and CTAs
• Conduct oversight monitoring activities, as needed
• Partner with data management colleagues to lead study data review activities
• Provide oversight of the ongoing maintenance of the Trial Master File
• Contribute to development of clinical study reports
• Monitor compliance with all company standard operating procedures (SOPs), GCP, FDA and applicable international regulations concerning clinical activities
• Create and implement Study Management plans and processes in compliance with industry standards and regulatory requirements
• Represent clinical operations in cross-functional initiatives and act on behalf of team, as assigned by management
• Provide direct line management, oversight, and operational guidance to contract Clinical Operations personnel (e.g., contract CTMs, CRAs, or CTAs).
• Travel internationally and domestically as required

• Minimum of 8 years of pharma/biotech clinical operations experience with a Bachelor’s degree in a relevant scientific discipline or equivalent (6 years with a Master’s, or 3 years with a PhD). Requires proven end-to-end management of complex clinical trials, with gene therapy experience strongly preferred
• Thorough knowledge and understanding of FDA and ICH Guidelines, Good Clinical Practices (GCP), medical terminology, and clinical trials
• Detailed understanding of all aspects of clinical protocol design and implementation and overall drug development
• Outstanding project management experience
• History of success selecting and managing vendors with performance standards
• Strong financial acumen measured by outstanding track record of building budgets and managing expenses to budget.
• Proficiency with word processing, spreadsheet, database, and presentation software and with filing (archiving) systems
• Demonstrated problem solving abilities and strong organizational skills
• Outstanding written communication skills including writing technical documents, such as protocols, protocol amendments, informed consent, and other trial-related documents
• Must be self-motivating, prioritize and manage a large volume of work, and show attention to detail
• Strong interpersonal skills with reputation for collaboration with colleagues; influencing up, down and across the organization
• Excellent verbal and written communication skills required including writing clearly and summarize information effectively

For candidates based in the San Francisco Bay Area the salary range for this position is 160,000 - 180,000

For candidates based outside the San Francisco Bay Area, the salary range is 145,000 - 165,000

Encoded considers a variety of factors when determining base compensation, including experience, qualifications, internal equity and geographic location. Actual compensation will be determined based on relevant skills, experience, qualifications, internal equity, and business needs. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package.

• Comprehensive benefits package, including competitive employer premium contributions

• Meaningful stock option grants
• PTO, sick time and holiday pay
• Generous Parental Leave program
• Pre-tax medical and dependent care programs
• STD, LTD, Life and AD&D
• Professional development opportunities
• Team-building events
• Fully stocked micro - kitchen
• Fitness center at South San Francisco location

Encoded is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Encoded is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Encoded are based on business needs, job requirements and individual qualifications, without regard to race, religion or belief, color, national origin, gender, status as a protected veteran, status as an individual with a disability, or any other status protected by the laws or regulations in the location in which we operate. Encoded will not tolerate discrimination or harassment based on any of these characteristics. Encoded encourages applicants of all ages.

If you need assistance or an accommodation due to a disability, you may call us at [phone].