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Clinical Program Manager
Encoded Therapeutics Inc.. Lead the operational strategy and execution for a novel clinical-stage gene therapy program .
Posted 10/27/2026full-timeRemote • United StatesMid-LevelSenior💰 $145,000 - $180,000 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in managing complex clinical trials, particularly in gene therapy, with a strong understanding of FDA and ICH guidelines, GCP, and clinical protocol design. Proven ability to lead cross-functional teams, manage budgets, and ensure compliance with regulatory requirements.
Highest-signal resume keywords
Clinical Operations ManagementGene Therapy ExperienceProject ManagementRegulatory ComplianceBudget Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial ManagementProtocol DevelopmentRisk Mitigation StrategiesClinical Study DocumentationData Review ActivitiesTrial Master File MaintenanceVendor ManagementFinancial AcumenClinical Protocol DesignDrug Development Knowledge
Soft Skills
Problem-Solving AbilitiesOrganizational SkillsInterpersonal SkillsCollaboration SkillsWritten Communication Skills
Tools & Technologies
Word Processing SystemsSpreadsheet SystemsDatabase SystemsPresentation SystemsFiling Systems
Industry Keywords
Clinical TrialsGood Clinical Practices (GCP)FDA RequirementsINDsCTAsMedical TerminologyInternational RegulationsEnrollment GoalsStudy Management PlansCross-Functional Initiatives
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Lead the operational strategy and execution for a novel clinical-stage gene therapy program
- Manage end-to-end operational execution from protocol concept through Clinical Study Report completion
- Drive cross-functional alignment, trial budgets, and project timelines
- Develop clinical 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 and budgets
- Select study investigators and evaluate their research capabilities and ability to meet timelines
- Build relationships with clinical sites and manage studies to meet enrollment goals
- Contribute to INDs, CTAs, and other regulatory documents
- Conduct oversight monitoring activities as needed
- Partner with data management colleagues to lead study data review activities
- Oversee ongoing Trial Master File maintenance
- Contribute to clinical study reports
- Monitor compliance with company SOPs, GCP, FDA requirements, and applicable international regulations
- Create and implement Study Management plans and processes
- Represent clinical operations in cross-functional initiatives and act on behalf of the team as assigned
- Provide direct line management, oversight, and operational guidance to contract Clinical Operations personnel
- Report to the Senior Director of Clinical Operations
Requirements
What you’ll need- 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)
- Proven end-to-end management of complex clinical trials; 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 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, including building budgets and managing expenses to budget
- Proficiency with word processing, spreadsheet, database, presentation, and filing (archiving) systems
- Demonstrated problem-solving abilities and strong organizational skills
- Outstanding written communication skills, including writing technical trial documents
- Ability to self-motivate, prioritize and manage a large volume of work, and demonstrate attention to detail
- Strong interpersonal and collaboration skills
- Excellent verbal and written communication skills
- Ability to travel internationally and domestically as required
Benefits
Comp & perks- 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
- Discretionary annual bonus
- Discretionary stock-based long-term incentives