[Hiring] Clinical Program Manager @Encoded Therapeutics

Role Description

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.

• 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.
• Manage 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 summarizing information effectively.

Benefits

• For candidates based in the San Francisco Bay Area, the salary range for this position is 160,000 - 180,000.
• For candidates based outside the San Francisco Bay Area, the salary range is 145,000 - 165,000.
• Encoded considers a variety of factors when determining base compensation, including experience, qualifications, internal equity and geographic location.
• This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and 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.