Director, Clinical Development – Gene Therapy

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $275k - $335k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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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

• Provide clinical development support for multiple gene therapy programs across different stages of the drug development lifecycle • Support clinical development for ETX301 and pharmacovigilance and medical monitoring for ETX101 • Support investigator management and collaborate in regulatory interactions and patient advocacy outreach • Contribute subject matter expertise to content and publications • Support clinical development strategy for programs targeting chronic neuropathic pain • Lead activities related to Phase 1–4 clinical trials, including authoring and reviewing protocols, investigator brochures, and clinical study reports, and managing CROs • Define, plan, and provide medical monitoring support across ongoing and completed studies for Dravet syndrome and chronic neuropathic pain • Review adverse events, monitor real-time safety data, prepare analyses and clinical input for regulatory submissions, and lead data interpretation with pharmacovigilance CRO partners • Serve as clinical representative for Data Monitoring Committee safety reviews and ensure continuous safety monitoring • Evaluate complex screening data and confirm participant eligibility with the Eligibility Review Committee • Build relationships with KOLs, principal investigators, pediatric clinical trial networks, outcomes experts, and patient advocacy organizations • Lead investigator meetings and site initiation visits and partner with Clinical Operations and Medical Affairs to drive enrollment • Define roles, responsibilities, and performance objectives for direct reports; provide feedback and identify growth opportunities • Collaborate with internal clinical, regulatory, scientific, and operational colleagues and external experts, investigators, and government agencies

🎯 Requirements

• MD, DO, or equivalent international medical degree required • 3+ years of clinical development experience in biotech/pharma required for the Director level • Equivalent academic physician-scientist experience leading clinical trials as a principal investigator will also be considered • Demonstrated experience designing and executing clinical trials, including strong vendor management skills • Ability to communicate efficiently with scientists, thought leaders, investigators, and executive management • Proven track record in medical monitoring, evaluating potential dose-limiting toxicities, pharmacovigilance, and GCP/ICH regulatory compliance • Experience overseeing protocol-mandated prophylactic immunomodulation regimens is highly desirable • Experience managing direct reports, leading cross-functional project teams, and building collaborative relationships with key opinion leaders • Exceptional oral and written communication skills, including translating complex clinical data into presentations, regulatory documents, and peer-reviewed publications • Strong collaboration and personal interaction skills with internal stakeholders across Regulatory Affairs, Medical Affairs, Clinical Operations, Biometrics, Research, and Translational Science • Strong computer skills, including MS Office Suite, electronic data capture systems such as RAVE and InForm, data analysis software, and data presentation • Ability to travel up to 25%, including possible international travel • Board certification or eligibility in specified medical specialties preferred • Specific experience in gene therapies, rare disease, epilepsy, chronic pain management, medical monitoring, and pharmacovigilance preferred • Experience with clinical-regulatory strategies and/or industry-academic collaborations preferred • Experience providing clinical input for regulatory submissions and engaging with global health authorities preferred • Knowledge of AAV gene or cell therapy risks, immunogenicity, dorsal root ganglionopathy, hepatotoxicity, and long-term follow-up requirements preferred

🏖️ 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