Clinical Program Manager (Gene Therapy)
Encoded Therapeutics
Summary
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.
Job description
Responsibilities
- 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
Qualifications
- 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
Requirements
- 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 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
Benefits
- Competitive employer premium contributions
- Stock option grants
- PTO, sick time & holiday pay
- Parental leave program
- Pre-tax medical programs
- Dependent care programs
- STD, LTD, Life & AD&D
- Professional development opportunities
- Team-building events
- Fitness center
Company overview
Encoded Therapeutics is a clinical-stage biotechnology company pioneering precision genetic medicines for severe central nervous system (CNS) disorders. Founded in 2014 and headquartered in South San Francisco, California, the company is developing potentially disease-modifying gene therapies for pediatric CNS conditions using its proprietary vector engineering platform. Encoded's innovative approach combines novel regulatory elements and payloads with AAV vectors to achieve unprecedented gene specificity and cell selectivity, enabling targeted expression of therapeutic transgenes in specific cell types. The company's flagship program, ETX101, targets Dravet syndrome and has received RMAT designation from the FDA. Encoded's pipeline also includes programs for Angelman syndrome, Lennox-Gastaut syndrome, STXBP1-related disorders, Alzheimer's disease, and neuropathic pain. With a team of 51-200 employees and significant venture backing including a $135 million Series D round, Encoded is advancing potentially transformative one-time gene therapies that could address significant unmet medical needs in neurological disorders.