MapLight Therapeutics, Inc.

Attorney

• Be responsible for the operation and administration of the company’s contract management system, acting as the key point of contact for the business
• Coordinate and assist in developing policies, procedures and systems to support and facilitate efficient contract development and analysis
• Draft, review and negotiate a variety of day-to-day contracts, including non-disclosure agreements, master service agreements, consulting agreements, manufacturing and supply agreements, clinical trial agreements and other clinical documents, independently and with limited supervision
• Negotiate to conclude agreements as efficiently as possible while meeting client needs and safeguarding MapLight’s interests
• Effectively manage outside vendors, including working with and supervising outside counsel, as required
• Create, improve, and implement applicable forms, templates, processes, and procedures to improve efficiency
• Obtain and maintain a strong working knowledge of the Company’s business, scientific capabilities, and key strategic business objectives

Contracts and Legal Systems Manager

Director

• Manage safety surveillance and signal detection activities (period review of aggregate safety data, safety surveillance team meetings, track signals and related documentation)
• Represent PV at clinical study team for assigned product
• Develop signal assessment report under the oversight of Program safety lead for validated safety signal
• Collaborate with PV operations for timely and accurate medical review of ICSRs for assigned clinical study as needed
• Develop and contribute safety risk management plan across product lifecycle
• Develop and manage periodic reports (DSUR/PBRER)
• Contribute for data analysis and authoring of safety sections for regulatory submissions and regulatory responses
• Contribute for the development or updates of safety surveillance and risk management SOPs, templates etc.
• Collaborate with clinical study teams on safety surveillance deliverables (IB, RSI, Protocol, Briefing documents etc.)
• Participating in PV audit and inspections
• Represent Pharmacovigilance function in committees and activities both internally and externally when appropriate.

Director, Safety Scientist – Pharmacovigilance

Strategy

• Conduct market research and competitive analysis across therapeutic areas and pipeline assets
• Support evaluation of business development opportunities, including partnerships, licensing, and M&A
• Build and maintain financial models, forecasts, and valuation analyses
• Prepare presentations and materials for executive leadership and board discussions
• Analyze industry trends, clinical developments, and regulatory landscapes
• Support clinical and commercial planning through primary and secondary research

Corporate Strategy Intern

• Ensure global clinical monitoring is executed with high standards of quality and consistency
• Oversee Lead CRAs and provide support and guidance for their management of monitoring teams
• Enhance the framework for clinical site monitoring and site management strategies
• Oversee the Clinical Operations Systems team to support the continued development, efficiency and integrity of the eTMF and CTMS systems
• Accountable to strengthen the monitoring, site management and clinical systems quality oversight strategy
• Develop standardized key performance indicators (KPIs) and key quality indicators (KQIs)
• Grow and develop team members in the clinical monitoring and operations systems team
• Represents the monitoring and clinical operations system functions in senior management meetings

Senior Director, Head of Clinical Monitoring and Operational Systems

• Collaborate with colleagues on a matrix team to ensure the optimal planning, implementation, interpretation and reporting of clinical studies, including:
• Contribute to the design of study synopses/protocols that will rigorously evaluate the efficacy and safety of compounds in development
• Participate in vendor selection and study start-up processes and study-related plans
• Monitor clinical studies, focusing on quality and adherence to Good Clinical Practice
• Continually evaluate study data and study metrics, including eligibility criteria, trend analyses, outlier analyses, protocol compliance, deviations, and timelines
• Partner with pharmacovigilance to review and report clinical safety data for presentation to key internal and external stakeholders, including management and Data Safety Boards
• Interact with sites and CROs to support study awareness, patient recruitment, and quality of study conduct
• Contribute to the preparation and review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and development plans.
• Participate in study start-up processes
• Contribute to the writing of final study reports
• Promote a high-performance culture and respectful work environment.
• Comply with all applicable laws, regulations and regulatory guidelines as well as SOPs and ethical standards.
• You can participate and work effectively with multiple cross-functional teams.
• You have strong interpersonal skills and understand relationships are key to being successful.
• You are a leader. Teams love working with you, and you are someone who takes pride in mentoring and supporting the careers of others.
• You’re a team player who is willing to roll-up your sleeves and get the job done.

Director, Clinical Development

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.

Contracts and Legal Systems Manager

Director, Safety Scientist – Pharmacovigilance

Corporate Strategy Intern

Senior Director, Head of Clinical Monitoring and Operational Systems

Director, Clinical Development

Medical Director – Senior, Clinical Development