MapLight Therapeutics

Role Description The Sr. CRA will perform quality and compliant Investigator site monitoring and relationship-driven Investigator site management in line with MapLight’s SOPs, our Mission, Vision, and Values, as well as industry quality and regulatory best practices (ICH GCP). The CRA will perform on-site monitoring and centralized monitoring to ensure subject safety, the highest data integrity, and contribute to proactive risk management and inspection readiness. This role will collaborate closely with key cross-functional internal stakeholders including: - Clinical Operations - Medical Monitoring - Data Management - Supply Chain - Clinical Compliance and Quality External CRO and vendor partners will also be involved to ensure quality study oversight from study start up through close out. CNS and/or neuropsychiatry, specifically in-patient schizophrenia and/or Alzheimer’s disease psychosis or Alzheimer's disease agitation experience strongly preferred. Responsibilities - Effectively manage assigned Investigator sites and maintain positive relationships with site personnel. - Prepare for and conduct Pre-Study, Initiation, Interim and Closeout monitoring visits in accordance with MapLight SOPs and procedures, regulatory requirements and industry guidelines and best practices (ICH GCP). - Support the study team in meeting study milestones (site activation, DSMB meetings, database lock, etc.). - Perform centralized monitoring activities between on-site visits to ensure timely resolution of action items, oversight of study data quality and flow, and proactively identify and mitigate/manage study risks and issues. - Maintain quality and compliant documentation related to all aspects of site management including quality and ALCOA+ compliant monitoring visit reports, centralized monitoring reports, site contact reports, Trial Master File/Investigator Site File, etc. - Serve as the main MapLight point of contact for Investigator sites to support protocol compliance, streamlined communications, timely responses to site staff needs, and training needs. - Support the study team and Investigator sites during inspections or audits, as needed. - Perform other assigned tasks, as requested. - Support the study team(s) in development of study documents and procedures. - Support the development and maintenance of the study monitoring plan, templates, and tools. - Support the set-up, testing, and maintenance of study systems (EDC, eCOA, IRT, etc.) as well as related supporting documents (manuals, eCRF Completion Guidelines, etc.) in collaboration with MapLight and CRO/vendor study team members. - Continually review and reconcile the Trial Master File and Investigator Site File for assigned sites to ensure inspection readiness. - Maintain current knowledge of regulatory requirements and industry best practices related to monitoring, including centralized monitoring and risk-based monitoring. - Support development and process improvement for the MapLight monitoring function. - Support development and revision of SOPs, processes, templates, tools, and plans with the aim of continual improvement and streamlining. - Contribute to the maintenance and improvement of clinical systems to drive process improvement and efficiency. - Embody and demonstrate MapLight’s core values of Integrity, Collaboration, Bravery, and Dedication. Qualifications - Approximately 5 plus years in the clinical trial industry with at least 4 years of clinical monitoring experience including complex therapeutic areas, in-patient trials, and blinded trials. - CNS and/or neuropsychiatry, specifically in-patient schizophrenia and/or Alzheimer’s disease psychosis or Alzheimer's disease agitation experience strongly preferred. - Experience working in small/emerging biotech is ideal. - Experience managing multiple Investigator sites and multiple studies simultaneously. - Willingness to travel nationally to assigned Investigator sites as needed for required visits. - Ability to build relationships between Investigator sites and MapLight to foster strong collaboration, trust, and positive working relationships. - Strong working knowledge of Good Clinical Practices (GCPs), ALCOA+, and pertinent regulations. - Ability to engage collaboratively with internal and external stakeholders in a professional manner. - Strong interpersonal, oral, and written communication skills. - A self-starter with the ability to work independently and proactively. - Willingness to be a “team player” and take on additional responsibilities as requested. - Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan. - High attention to detail and focus on quality and compliance in all aspects of assigned work. - Experience working in various clinical software systems (EDC, CTMS, eTMF, eCOA, EMR). - Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Outlook). - Ability to travel independently by air, car and/or train. Location near a major airport preferred. Benefits - Compensation for this role may vary within the above range based on many factors including geographic location, candidate experience, and skills. - Additional compensation/benefits include: - Annual bonus opportunity - Medical, dental, vision, life and AD&D - Short term and long term disability - 401(K) plan with match - Stock options - Flexible non-accrual paid time off - Parental leave Salary Range $145,000 — $160,000 USD 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.

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. Compensation for this role may vary within the above range based on many factors including geographic location, candidate experience, and skills. Additional compensation/benefits include annual bonus opportunity, medical, dental, vision, life and AD&D, short term and long term disability, 401(K) plan with match, stock options, flexible non-accrual paid time off, and parental leave. Salary Range $275,000—$370,000 USD 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.