Director of Clinical Sciences

Summary

Join Encoded Therapeutics Inc., a biotechnology company focused on viral gene therapy, as their Director of Clinical Sciences. This strategic role involves designing, developing, and implementing clinical studies for rare epileptic and neurodevelopmental disorders. You will collaborate with cross-functional teams, lead scientific strategy for endpoint selection, oversee outcome measure development, and contribute to regulatory documents. The ideal candidate possesses a PhD in Neuropsychology, extensive experience in clinical trials, and expertise in neuropsychological testing. This position offers a competitive salary, comprehensive benefits, and opportunities for professional development. Encoded is committed to providing a supportive and inclusive work environment.

Requirements

• PhD in Clinical Psychology Neuropsychology or related field with 7–10+ years of experience in industry or academia, preferably in biotech or pharmaceutical clinical development
• Strong understanding of rare CNS/epilepsy/neurodevelopmental disorder indications, including developmental and epileptic encephalopathies
• Expertise in neuropsychological testing, behavior assessment tools, and patient-reported outcomes (PROs), especially in pediatric populations
• Demonstrated experience in the design and execution of clinical trials and familiarity with GCP/ICH guidelines and regulatory expectations
• Ability to interpret complex data and communicate clearly with both scientific and non-scientific stakeholders
• Strong collaboration skills and the ability to thrive in a fast-paced, mission-driven environment

Responsibilities

• Serve as the clinical science lead on cross-functional development teams for one or more rare disease programs in epilepsy or related CNS conditions
• Collaborate with Medical Directors, Clinical Operations, Biometrics, and Regulatory Affairs to design and execute clinical trials (Phase I–III), including natural history studies and interventional trials
• Lead the scientific strategy behind endpoint selection, particularly neurocognitive, behavioral, and quality-of-life measures relevant to pediatric and neurodevelopmental disorders
• Oversee development and validation of clinically meaningful outcome measures and contribute to the 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 to support regulatory filings, publications, and scientific communications
• Serve as a scientific subject matter expert in neurodevelopmental and cognitive outcomes—both internally and externally
• Support interactions with regulators, KOLs, advisory boards, and patient advocacy groups

Preferred Qualifications

• Experience working with rare diseases, particularly pediatric neurodevelopmental / neurobehavioral disorders
• Prior involvement with clinical outcome assessments (COAs), FDA interactions, and/or endpoint qualification initiatives
• Knowledge of genetic testing and biomarkers in the context of neurodevelopmental disorders

Benefits

• A hired applicant may be eligible for an annual bonus as well as equity under the company’s stock plan
• 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 kitchen
• Purple Tie dry cleaning service
• Fitness center
• Employees (and their families) may obtain medical, dental, vision and basic life insurance benefits through the company and enroll in our company's 401k plan
• Employees will also accrue vacation time off and paid sick time off and may become eligible for paid parental leave
• Employees will also enjoy designated paid holidays throughout the calendar year