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 Vice President of Pharmacovigilance. This is a key leadership role that will shape the future direction and growth of Drug Safety at Denali. The successful candidate will be responsible for strategic implementation, execution, and oversight of pharmacovigilance and risk management activities for Denali’s development programs according to industry standards and global regulations. The Head of PV will lead, contribute to, and provide oversight for safety science and PV operations, ensuring appropriate processes, staff, and systems are in place to enable proactive and timely risk-benefit assessments and safety reporting for investigational products.
The successful candidate has a stellar medical science background; is experienced in risk management across global regions and in pre- and post-approval settings; is a collaborative leader and self-starter who thrives in a matrixed environment; and has demonstrated leadership excellence in building and managing teams including contract research organizations.
Oversees and directs all aspects of global pharmacovigilance and risk management activities for investigational compounds; actively participates in oversight of patient safety in all clinical trials
Provides strategic planning, implementation, and management of drug safety activities to support clinical development of company products
Directs the development, preparation, and compliance of periodic and annual safety reports, investigator communications, and other reports as necessary
Ensures expert safety review of critical development program documents including protocols, ICFs, IBs, IMPDs, CSRs, INDs, CTAs, and NDA/BLA/MAAs.
Provides medical review of cases to ensure the accuracy, integrity and completeness of information entered in the safety database
Leads the development and maintenance of signal management, safety surveillance and risk management plans for drug development programs
Takes lead role in responding to and resolving safety questions from regulatory authorities, as well as regulatory agency audits and inspections, and corrective action plans.
Manages internal employees and external contractors to ensure delivery of quality drug safety and pharmacovigilance activities; selects, develops, trains, and evaluates team to ensure the efficient operation of the drug safety function
Manages the process for identifying, evaluating, and selecting outsourcing vendors
Ensures compliance with all applicable laws and regulations and as appropriate, local and foreign regulatory reporting requirements, for the processing and reporting of adverse events
Ensures training of appropriate personnel and external groups of PV and Drug Safety principles, policies and SOPs
Prepares and maintains departmental policies and SOPs that address the processing, analysis and reporting of safety information to ensure proactive surveillance of products in development
Monitors industry best practices, changes in global safety regulations and guidelines for marketed and investigational projects to ensure departmental policies, SOPs and systems are current
Provides pharmacovigilance guidance and support for interdepartmental and/or corporate initiatives
Participates in the development and management of departmental budget
Advanced medical degree (e.g., MD, MBBS, DO) required
12+ years of experience in the pharmaceutical industry and a minimum of 8 years in leadership positions in drug safety and pharmacovigilance in the clinical trial and post-marketing environments.
A minimum of 8 years of project or line management experience overseeing PV staff and/or consultants/CROs
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.