Senior Medical Director, Pharmacovigilance

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MapLight Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

11 - 50 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Biotechnology • Healthcare Insurance • Pharmaceuticals

MapLight Therapeutics, Inc. is a biotechnology company dedicated to transforming the treatment of brain disorders, including conditions such as schizophrenia, Alzheimer’s disease, and autism spectrum disorder. They leverage advanced technologies like optogenetics and transcriptomics to identify specific neural circuits involved in these disorders, aiming to develop targeted therapeutics with the potential to significantly improve patient outcomes. Their innovative discovery platform supports a robust pipeline of clinical and preclinical trials focused on addressing significant unmet medical needs in central nervous system conditions.

📋 Description

• 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.

🎯 Requirements

• MD or equivalent with 3-5 years of relevant clinical experience • Minimum 10 years’ industry experience, within Drug safety/Pharmacovigilance with investigational and/or marketed products • Proven experience in safety data analysis, signal management, and benefit-risk evaluation • Working knowledge of safety databases (Argus, ArisG/LifeSphere Safety, or similar) • Demonstrated ability to develop and implement drug safety strategies and risk management plans • Proven experience with authoring or contributing to clinical study and regulatory submission documents • Working knowledge of relevant local and global regulatory requirements and guidance documents • Able to lead in a cross functional setting and work collaboratively with internal and external partners in a fast-paced environment • Effective oral and written communication skills. • Highly motivated, self-driven and dependable.

🏖️ Benefits

• 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