MapLight Therapeutics, Inc.

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.

Senior Medical Director, Pharmacovigilance

Director

• Provide/validate sample size/power calculation and author statistical section of the protocol.
• Responsible for the development of study SAP and table/figure/listing shells including overseeing CRO’s work.
• Work collaboratively with Clinical Development, Clinical Operations, Clinical Data Managers, Regulatory and other functions to meet project deliverables and timelines.
• Provide statistical and strategic inputs in documents prepared for regulatory interactions.
• Provide technical oversight of statistical activities of external vendors to ensure timeliness and quality of analysis data and statistical outputs. Review and approve key statistical vendor deliverables.
• Contribute to clinical study reports, including authoring of statistical methods and interpretation of the study results.
• Support and contribute to the preparation of publications, including manuscripts, posters and oral presentations.

Senior Medical Director, Pharmacovigilance

Director, Biostatistics