Clinical Program Manager

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $145k - $180k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 0%

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Encoded Therapeutics Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2013

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Encoded Therapeutics Inc. is a biotechnology company focused on developing innovative genetic medicines to address central nervous system (CNS) disorders. Their work aims to tackle the root causes of these disorders, providing potentially transformative, long-lasting therapies designed to improve patient outcomes and quality of life, particularly for conditions such as Dravet Syndrome and Angelman Syndrome. The company uses a unique targeting and regulation platform allowing for increased gene specificity and cell selectivity, overcoming challenges associated with first-generation gene therapies. Encoded Therapeutics is dedicated to translating cutting-edge science into practical, life-changing solutions for patients worldwide.

📋 Description

• 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

• 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

• 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