Associate Director – Clinical Sciences
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Job Description
Pediatric neuropsychologist leading clinical science for rare epilepsy and neurodevelopmental disorders. Supporting precision gene therapy trials, assessments, regulatory filings, and patient-focused outcomes.
Responsibilities:
- 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
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