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.

Requirements

MD or equivalent
Preferred: Board Certified/Board Eligible in neurology, child neurology, developmental-behavioral pediatrics, or psychiatry
Minimum 3 years of CNS research experience required
Preferred: Minimum 5 years of industry experience, including demonstrated success in leading and implementing clinical development strategies and trials
Preferred: Experience in neurodevelopmental disorders, particularly autism spectrum disorder or related conditions
Experience with clinical trial design in pediatric and/or heterogeneous populations, including use of behavioral and functional endpoints
Preferred: Meaningful regulatory interactions, including IND and/or NDA experience
Established relationships with thought leaders and investigators in autism or neurodevelopmental disorders
Demonstrated ability to work effectively in geographically diverse teams
Proven ability to lead and manage cross-functional teams
Ability to thrive in a growing organization and contribute to advancing leadership in CNS and neurodevelopmental therapeutics
Strong commitment to patient-centered development, including engagement with caregivers and advocacy communities
Excellent oral and written communication skills
Fluent in written and spoken business English
Highly motivated, self-driven, and dependable
Committed to MapLight’s Core Beliefs and Values.

Benefits

Annual bonus opportunity
Medical, dental, vision, life and AD&D insurance
Short term and long term disability insurance
401(K) plan with match
Stock options
Flexible non-accrual paid time off
Parental leave

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical trial designclinical outcome assessmentsendpoint selectionregulatory documents preparationIND submissionssafety reportsclinical development planspharmacovigilanceCNS researchneurodevelopmental therapeutics

Soft Skills

leadershipcommunicationcollaborationrelationship buildingstrategic planningaccountabilityresponsivenessinnovationteam managementpatient-centered development

Certifications

MDBoard Certified in neurologyBoard Certified in child neurologyBoard Certified in developmental-behavioral pediatricsBoard Certified in psychiatry