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
Travel:
- Ability to travel (approximately 25%).
Location: This is a remote US base position. Employees located within a 50 mile radius of Redwood City, CA or Burlington, MA is hybrid in office.
MapLight does not accept unsolicited resumes from recruiters, staffing agencies, or search firms.
EEOC Statement: MapLight Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.