MapLight Therapeutics, Inc.

Medical Director

• Provide overall leadership and management of a cross-functional development team, accountable for the development of a therapeutic candidate for autism spectrum disorder (ASD)
• Support the Senior Vice President, Clinical Development, on issues critical to optimizing quality, efficiency, engagement, accountability, and responsiveness of the department, including strategic planning, execution, innovation, communication, and governance
• Ensure study adherence to Good Clinical Practice (GCP) and applicable regulatory standards
• Lead ongoing evaluation of study data and metrics, including endpoint selection, clinical outcome assessments, and eligibility criteria appropriate for autism populations
• Partner with pharmacovigilance to review and communicate clinical safety data to internal and external stakeholders, including executive leadership and Data Safety Monitoring Boards
• Collaborate with clinical sites and CROs to support study awareness, patient recruitment and retention in pediatric and neurodiverse populations, and high-quality study conduct
• Contribute to the preparation and review of regulatory documents, including IND submissions, IND annual reports, safety reports, Investigator Brochures, and clinical development plans
• Build and maintain strong relationships with investigators, key opinion leaders, advocacy organizations, caregivers, and centers of excellence in autism and neurodevelopmental disorders
• Communicate program strategy, progress, risks, and results clearly to key stakeholders
• Provide clinical and scientific leadership to advance programs from discovery through development and into lifecycle management
• Evaluate business development opportunities and translate them into effective and differentiated development strategies aligned with regulatory expectations in neurodevelopmental therapeutics
• Ensure compliance with all applicable global regulations, GCP, and company policies.

Medical Director – Senior, Clinical Development

Director

• Serve as both the Clinical Pharmacology and Pharmacometrics Lead for clinical programs.
• Apply expertise in pharmacokinetics, pharmacodynamics, and quantitative modeling to guide dose selection.
• Collaborate with Clinical Operations, Biometrics, Regulatory Affairs, Medical Affairs, Toxicology, and Pharmacology.
• Provide strategic input into the progression of drug candidates from pre-IND through NDA submission.
• Design and provide input into clinical study protocols, reports, and related documentation.
• Perform, interpret, and communicate PK and PD analyses to support dose selection and clinical decision-making.
• Author and contribute to regulatory submissions and represent the company in interactions with global health authorities.

Director, Clinical Pharmacology – Pharmacometrics

Compliance

• Lead global regulatory strategy for development-stage neuroscience programs.
• Serve as the regulatory lead on cross-functional teams and be responsible for developing and implementing global regulatory strategies.
• Work with the Sr Director, Regulatory Affairs to develop and direct innovative and effective regulatory strategies.
• Provide advice on regulatory issues and actively collaborate with cross-functional team members.
• Represent MapLight as a point of contact with FDA and provide support for regulatory meetings and briefing document development.
• Provide regulatory guidance on clinical development plans, CMC strategies, and nonclinical programs.
• Lead or oversee the preparation and submission of regulatory documents.
• Monitor changes in the regulatory landscape relevant to neuroscience.