Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.
In anticipation of the Company’s growth plans, Denali Therapeutics is seeking a Senior Medical Director of Pharmacovigilance. The Sr. Medical Director will provide safety expertise and leadership across the growing clinical stage portfolio.
Monitors the benefit risk profile across the clinical portfolio, in an ongoing fashion in accordance with good pharmacovigilance practice (GVP), as an embedded member of clinical project teams
Responsible for identifying, prioritizing, and leading analysis of clinical safety signals
Performs ongoing review of emerging safety data from various sources including single case reports, trial results, published literature, partner studies
Performs medical review of all cases to ensure the accuracy, integrity and completeness of information entered in the safety database
Ensures effective and timely delivery of high quality safety documents. Aggregate reports including Development Safety Update Reports (DSURs), [future] development risk management plans (DRMPs) and risk management plans (RMPs), benefit risk statements, and responses to regulatory queries
Assists in the preparation and review of safety section(s) of investigator brochures, protocols, informed consent forms, statistical analysis plans, clinical study reports, IND/NDA/BLA/ submissions
Leads the Pharmacovigilance (PV) risk management planning for late stage programs
Supports Safety Operations to develop and continuously maintain and improve effective PV systems and processes
Collaborates and provides pharmacovigilance guidance and support for interdepartmental and/or corporate initiatives
MD degree and general medical experience required
5+ years of drug safety experience in the pharmaceutical industry, including program safety leadership in the pre-approval setting.
Strong working knowledge of global PV requirements (e.g., US Code of Federal (CFR) regulations; European Union (EU); Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines.