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Salary: USD 195,000 - 220,000 / annual
Encoded Therapeutics is a biotechnology company developing precision medicines for genetic disorders through viral gene therapy. The company seeks a pediatric neuropsychologist to join the Clinical Sciences team as an Associate Director, playing a hands-on role in implementing clinical studies focused on rare epileptic and neurodevelopmental disorders.
Key Responsibilities:
- Collaborate with Medical Affairs, Clinical Operations, Biometrics, and Regulatory Affairs to execute Phase I–III clinical trials
- Lead clinical training initiatives for central and site raters on complex pediatric neurodevelopmental and behavioral assessments
- Provide scientific oversight for operational execution of clinical assessments, maintaining rigorous quality control standards
- Support scientific strategy for endpoint selection, particularly neurocognitive, behavioral, and quality-of-life measures relevant to pediatric and neurodevelopmental disorders
- Contribute to statistical analysis plans related to neuropsychological assessments
- Contribute to clinical study protocols, investigator brochures, clinical study reports (CSRs), and regulatory documents (INDs, briefing books, NDAs)
- Interpret clinical data and generate high-quality summaries and insights for regulatory filings, publications, and scientific communications
- Support interactions with regulators, key opinion leaders, 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, Vineland-3, etc.
- Demonstrated experience in the design and execution of clinical trials and 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
Preferred Qualifications:
- 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
