Senior Medical Director, Pharmacovigilance

About the Company

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.

Responsibilities

• 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
• Review safety data from pre-clinical, clinical trial, post-marketing, and literature sources
• Conduct signal detection activities, monitoring, evaluation, and interpretation of safety information
• Represent pharmacovigilance on cross-functional teams for review of protocols, investigator brochures, and informed consent forms
• Responsible for strategy and key content of Risk Management documents (DRMPs, RMPs, REMS)
• Provide medical interpretation, review, and approval of periodic reports
• Perform medical review of all adverse event reports for seriousness, expectedness, and causality
• Coach, mentor, and manage safety scientists

Requirements

• MD or equivalent with 3-5 years of relevant clinical experience
• Minimum 10 years of industry experience within Drug safety/Pharmacovigilance
• Proven experience in safety data analysis, signal management, and benefit-risk evaluation
• Working knowledge of safety databases such as Argus or ArisG/LifeSphere Safety
• Demonstrated ability to develop drug safety strategies and risk management plans
• Experience with authoring clinical study and regulatory submission documents
• Knowledge of local and global regulatory requirements and guidance documents

Preferred Qualifications

• Board Certified/Board Eligible in Neurology or psychiatry
• Experience in NDA/IND submissions in neuroscience, psychiatry, or neurodegenerative therapeutic areas