Clinical Program Manager

Encoded Therapeutics

7h•$145,000 - $180,000

About The Position

Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for genetic disorders through genomics-driven discovery and viral gene therapy. Reporting to the Senior Director of Clinical Operations, the Clinical Program Manager leads operational strategy and execution for a novel clinical-stage gene therapy program. The role works with the Medical Monitor, cross-functional trial teams, and external experts to plan clinical trials, develop protocols, select sites and vendors, and support study startup and corporate development goals. The Clinical Program Manager is accountable for end-to-end clinical program execution, from protocol concept through Clinical Study Report completion. The role oversees alignment across functions, timelines, budgets, study documents and procedures, site and vendor activities, enrollment, data review, Trial Master File maintenance, regulatory documentation, and compliance with company SOPs, GCP, FDA requirements, and applicable international regulations. It also provides operational guidance and direct line management to contract Clinical Operations personnel and represents Clinical Operations in cross-functional initiatives. Domestic and international travel is required as needed.

Requirements

At least 8 years of pharma/biotech clinical operations experience with a Bachelor’s degree in a relevant scientific discipline or equivalent; alternatively, 6 years with a Master’s degree or 3 years with a PhD.
Proven end-to-end management of complex clinical trials.
Thorough knowledge of FDA and ICH guidelines, Good Clinical Practices (GCP), medical terminology, and clinical trials.
Detailed understanding of clinical protocol design and implementation and overall drug development.
Outstanding project management experience.
A record of success selecting and managing vendors using performance standards.
Strong financial acumen, including a track record of building budgets and managing expenses to budget.
Proficiency with word processing, spreadsheet, database, and presentation software, and filing or archiving systems.
Demonstrated problem-solving abilities and strong organizational skills.
Outstanding written communication skills, including the ability to write technical documents such as protocols, amendments, informed consent forms, and other trial-related documents.
Self-motivated, able to prioritize and manage a large volume of work, and attentive to detail.
Strong interpersonal skills and a reputation for collaboration with colleagues and influencing across organizational levels.
Excellent verbal and written communication skills, including the ability to write clearly and summarize information effectively.

Nice To Haves

Gene therapy experience is strongly preferred.

Responsibilities

Lead 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 Clinical Study Report completion.
Develop study documents and procedures, including protocols, informed consent forms, investigator brochures, case report forms, and study procedure manuals.
Identify and interpret risks and implement mitigation strategies and corrective actions.
Develop and manage clinical study timelines consistent with company goals.
Develop and manage study budgets.
Select study investigators and evaluate their ability to conduct research and meet study timelines.
Build relationships with clinical sites.
Manage studies to meet enrollment goals.
Contribute to key regulatory documents, including INDs and CTAs.
Conduct oversight monitoring activities as needed.
Partner with data management colleagues to lead study data review activities.
Oversee ongoing maintenance of the Trial Master File.
Contribute to clinical study reports.
Monitor compliance with company SOPs, GCP, FDA requirements, 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 the team as assigned by management.
Provide direct line management, oversight, and operational guidance to contract Clinical Operations personnel, such as contract CTMs, CRAs, or CTAs.
Travel internationally and domestically as required.

Benefits

Discretionary annual bonus eligibility.
Discretionary stock-based long-term incentives.
Paid time off.
Comprehensive benefits package, including competitive employer premium contributions.
Meaningful stock option grants.
Sick time and holiday pay.
Generous parental leave program.
Pre-tax medical and dependent care programs.
Short-term disability, long-term disability, life, and AD&D coverage.
Professional development opportunities.
Team-building events.
Fully stocked micro-kitchen.
Fitness center at the South San Francisco location.