Associate Director – Clinical Sciences

🔥 17 hours ago

🇺🇸 United States – Remote

💵 $185k - $220k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ 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

• Collaborate with Medical Affairs, Clinical Operations, Biometrics, and Regulatory Affairs to execute Phase I–III clinical trials • Lead clinical training initiatives for central/site raters on complex pediatric neurodevelopmental and behavioral assessments • Provide scientific oversight for operational execution of clinical assessments • Uphold rigorous quality control standards for site-administered tests • Support scientific strategy behind endpoint selection, particularly neurocognitive, behavioral, and quality-of-life measures • Contribute to statistical analysis plans related to neuropsychological assessments • Contribute to clinical study protocols, investigator brochures, clinical study reports, and regulatory documents including INDs, briefing books, and NDAs • Interpret clinical data and generate summaries and insights for regulatory filings, publications, and scientific communications • Support interactions with regulators, KOLs, advisory boards, and patient advocacy groups

🎯 Requirements

• PhD in Clinical Psychology, Neuropsychology or related field with 2–5+ years of experience in industry or academia, preferably in biotech or pharmaceutical clinical development • Experience working with individuals with significant pediatric neurodevelopmental / neurobehavioral disorders • Expertise in neuropsychological testing, behavior assessment tools, and patient-reported outcomes (PROs), especially in pediatric populations • Extensive experience with developmental/adaptive functioning/cognitive measures such as Bayley-4 and Vineland-3 • Demonstrated experience in the design and execution of clinical trials • Familiarity with GCP/ICH guidelines • Ability to interpret complex data and communicate clearly with both scientific and non-scientific stakeholders • Strong collaboration skills and ability to thrive in a fast-paced, mission-driven environment • Strong understanding of rare CNS/epilepsy indications, including developmental and epileptic encephalopathies • Prior involvement with clinical outcome assessments (COAs), FDA interactions, and/or endpoint qualification initiatives • Experience integrating neurodevelopmental/behavioral outcomes with health economics/resource utilization studies • Expertise utilizing qualitative data in the context of clinical trials and/or regulatory interactions • Knowledge of genetic testing and biomarkers in the context of neurodevelopmental disorders

🏖️ Benefits

• Discretionary annual bonus • Discretionary stock-based long-term incentives • Paid time off • 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