Note: The job is a remote job and is open to candidates in USA. Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for genetic disorders. The Clinical Program Manager leads operational strategy and execution for a clinical-stage gene therapy program, including trial planning, study startup, cross-functional coordination, and clinical study completion.
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
Skills
- 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
- Gene therapy experience strongly preferred
Benefits
- This position may also be eligible for a discretionary annual bonus
- Discretionary stock-based long-term incentives
- Paid time off
- 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
Company Overview