MapLight Therapeutics, Inc.

Director

• Serve as both the Clinical Pharmacology and Pharmacometrics Lead for clinical programs.
• Apply expertise in pharmacokinetics, pharmacodynamics, and quantitative modeling to guide dose selection.
• Collaborate with Clinical Operations, Biometrics, Regulatory Affairs, Medical Affairs, Toxicology, and Pharmacology.
• Provide strategic input into the progression of drug candidates from pre-IND through NDA submission.
• Design and provide input into clinical study protocols, reports, and related documentation.
• Perform, interpret, and communicate PK and PD analyses to support dose selection and clinical decision-making.
• Author and contribute to regulatory submissions and represent the company in interactions with global health authorities.

Director, Clinical Pharmacology – Pharmacometrics

Compliance

• Lead global regulatory strategy for development-stage neuroscience programs.
• Serve as the regulatory lead on cross-functional teams and be responsible for developing and implementing global regulatory strategies.
• Work with the Sr Director, Regulatory Affairs to develop and direct innovative and effective regulatory strategies.
• Provide advice on regulatory issues and actively collaborate with cross-functional team members.
• Represent MapLight as a point of contact with FDA and provide support for regulatory meetings and briefing document development.
• Provide regulatory guidance on clinical development plans, CMC strategies, and nonclinical programs.
• Lead or oversee the preparation and submission of regulatory documents.
• Monitor changes in the regulatory landscape relevant to neuroscience.

Director, Regulatory Affairs

Research Scientist

• Lead the development and optimization of analytical methods for starting materials, intermediates and drug substances. Experienced with a wide range of techniques such as HPLC, GC, LC-MS, NMR, UV, FTIR, and other relevant analytical techniques to ensure method suitability for intended applications.
• Design and lead method validation activities to ensure methods meet ICH, FDA, EMA, and other applicable regulatory guidelines. Oversee method development and transfer activities to manufacturing or quality laboratories, ensuring clear documentation and effective technology transfer.
• Prepare, review, and approve technical documents such as standard operating procedures (SOPs), analytical study methods/protocols/reports, and product specifications.
• Author and review analytical sections of regulatory submissions (IND, IMPD, NDA/MAA) and support regulatory interactions as an analytical subject matter expert.
• Collaborate with process chemistry scientists, development teams, quality assurance, and regulatory affairs to ensure analytical needs are met across the product lifecycle.
• Lead or contribute to multi-disciplinary project teams, manage analytical development timelines and communicate progress to stakeholders.

Principal Scientist, Analytical Development – Drug Substance

• Lead development of small molecule solid-oral dosage formulations from pre-IND to Phase 3 including:
• Assess API physical and chemical properties as it relates to drug product manufacturability, performance and stability
• Evaluate phase-appropriate formulation approaches and enabling technologies to achieve the target drug product profile
• Design experiments to optimize the formulation and manufacturing process
• Oversee formulation development and GMP manufacturing activities at CDMOs:
• Lead DP endor section activities as necessary ad manage vendor relationship
• Effectively communicate scope of work, timelines, and priorities and monitor the deliverables and performance as it relates to the project objectives
• Drive review of batch records, protocols, reports, and other vendor documents
• Provide technical expertise and guidance to troubleshoot development and manufacturing challenges
• On-site presence for batch manufacturing activities at the CDMO as needed
• Represent formulation development group in cross-functional team and effectively communicate project status and technical risks with appropriate solutions
• Work closely with QA to ensure GMP activities are conducted in accordance with internal QMS
• Author/review internal technical reports and drug product sections of regulatory filings
• 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.

Associate Director – Formulation Development

• Lead the phase-appropriate development, scale-up, and optimization of cost-effective synthetic routes for small molecule drug substances intended for CNS therapeutics.
• Oversee and manage relationships with CROs and CDMOs to ensure timely and quality delivery of drug substance materials and data.
• Author and review CMC sections of regulatory filings including INDs, IMPDs, and NDAs. Ensure alignment with global regulatory expectations.
• Lead investigations and resolution of quality events (e.g., deviations, OOS, OOT). Collaborate with Quality Assurance to ensure compliance with GMP standards.
• Work closely with Analytical Development, Formulation, Regulatory Affairs, Drug Discovery, and Clinical Supply teams to support integrated development strategies.
• Drive timelines, budgets, and deliverables across multiple projects. Communicate progress and risks effectively to stakeholders.
• Prepare and critically review technical reports, protocols, and development summaries with high attention to detail.
• Foster a collaborative team environment and contribute to cross-functional problem solving and decision making.
• Promote technical excellence through mentoring, peer review, and continuous improvement initiatives.

Principal Scientist, Drug Substance Process Development

Medical Director

• Lead product safety surveillance and oversee evolving safety and benefit-risk profiles for assigned products.
• Lead cross-functional safety management team (SMT) for assigned products, and responsible for the on-going assessment of benefit-risk profiles and related actions during the product life cycle.
• Review safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the development process as well as post marketing for assigned products.
• Responsible for conducting signal detection activities, monitoring, evaluation, interpretation and appropriate management and communication of safety information
• Represent pharmacovigilance on cross-functional product/project teams including review of safety sections of protocols, investigator brochures, informed consent forms, and other documents with safety content.
• Responsible for strategy and key content of Risk Management documents (DRMPs, RMPs, REMS) and regulatory responses.
• Provide strategy and guidance to safety risk management scientists in writing of periodic reports for assigned products; provide medical interpretation, review and approval.
• Responsible for up-to-date representation of safety information in Company Core Data Sheet and Investigator Brochure, and other labeling documents.
• Perform the medical review of all adverse event reports for seriousness, expectedness and causality.
• Coach, mentor and manage safety scientists supporting the surveillance activities for assigned products.
• Represent Pharmacovigilance function in committees and activities both internally and externally when appropriate.

Director, Clinical Pharmacology – Pharmacometrics

Director, Regulatory Affairs

Principal Scientist, Analytical Development – Drug Substance

Associate Director – Formulation Development

Principal Scientist, Drug Substance Process Development

Senior Medical Director, Pharmacovigilance