Clinical Program Manager (Gene Therapy)

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 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 visit www.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.

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