Clinical Program Manager (Gene Therapy)
- Compensation
- Not disclosed
- Location
- United States
- Work setup
- Remote
- Seniority
- Not specified
- Employment
- Contract
- Experience
- 3+ years
- Category
- Project management
- Posted
Skills
Must have
- 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). Require
- 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
Full 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 .
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