Medical Director/Senior, Clinical Development

Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms.

What You’ll Do:

The Medical Director/Senior Medical Director, Clinical Development will lead development of a promising therapeutic candidate for autism spectrum disorder (ASD).  This role is pivotal within the R&D function, requiring deep expertise and a proven track record in drug development for neurodevelopmental and central nervous system (CNS) disorders. Reporting to the Senior Vice President, Clinical Development, the Senior Director will oversee cross-functional teams and may have direct reports.

Responsibilities:

• 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

We look for these behaviors in all ML employees:

• Ability to collaborate effectively across multiple cross-functional teams
• Strong interpersonal skills, with an appreciation for the importance of relationships
• Proven leadership mindset, with a passion for mentoring and developing others
• Willingness to be hands-on and contribute to team success in a fast-paced environment

Qualifications:

• 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