Associate Director – Clinical Sciences

This is a fully remote position, open to applicants in United States.

📋 Description

• Collaborate with Medical Affairs, Clinical Operations, Biometrics, and Regulatory Affairs to carry out Phase I–III clinical trials.

• Lead training programs for central and site raters on intricate pediatric neurodevelopmental and behavioral evaluations.

• Provide scientific oversight for the operational implementation of clinical assessments.

• Maintain high-quality control standards for tests administered at sites.

• Assist in formulating the scientific strategy for endpoint selection, focusing on neurocognitive, behavioral, and quality-of-life metrics.

• Contribute to the development of statistical analysis plans concerning neuropsychological evaluations.

• Aid in the creation of clinical study protocols, investigator brochures, clinical study reports, and regulatory documents such as INDs, briefing books, and NDAs.

• Analyze clinical data and produce summaries and insights for regulatory submissions, publications, and scientific communications.

• Facilitate interactions with regulators, key opinion leaders (KOLs), advisory boards, and patient advocacy organizations.

⛳️ Requirements

• PhD in Clinical Psychology, Neuropsychology, or a related discipline with 2–5+ years of experience in the industry or academia, preferably within biotech or pharmaceutical clinical development.

• Experience working with individuals diagnosed with significant pediatric neurodevelopmental or neurobehavioral disorders.

• Proficiency in neuropsychological testing, behavioral assessment tools, and patient-reported outcomes (PROs), particularly in pediatric populations.

• Extensive experience with developmental, adaptive functioning, and cognitive measures such as Bayley-4 and Vineland-3.

• Proven experience in designing and executing clinical trials.

• Knowledge of GCP/ICH regulations.

• Capability to interpret complex data and communicate effectively with both scientific and non-scientific audiences.

• Strong collaboration abilities and capacity to excel in a fast-paced, mission-focused environment.

• In-depth understanding of rare CNS/epilepsy indications, including developmental and epileptic encephalopathies.

• Previous involvement in clinical outcome assessments (COAs), FDA interactions, and/or endpoint qualification efforts.

• Experience combining neurodevelopmental and behavioral outcomes with health economics/resource utilization research.

• Expertise in utilizing qualitative data within the framework of clinical trials and/or regulatory engagements.

• Familiarity with genetic testing and biomarkers related to 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.

• Paid time off, sick leave, and holiday pay.

• Generous Parental Leave program.

• Pre-tax medical and dependent care programs.

• Short-term disability, long-term disability, life insurance, and AD&D.

• Opportunities for professional development.

• Team-building activities.

• Fully stocked micro-kitchen.

• Fitness center available at the South San Francisco location.