Reporting to the Vice President, Development Operations the Associate Director is responsible for the oversight and management of Pharmacovigilance activities, including oversight of aggregate reporting, overseeing signal management activities, oversight of management of responses to ad hoc regulatory responses, oversight of literature review/management for safety findings, and oversight of clinical trial safety activities. The Associate Director monitors resourcing and manages or reassigns tasks/projects across assigned programs and staff, as workload requires. The Associate Director is responsible for leading initiatives for process improvement, and collaborating across preclinical and clinical, and cross-functional groups to develop, implement and maintain processes that are compliant with global Pharmacovigilance regulations, improve efficiency and lead to consistent work processes across assigned product groups taking into account cross-program practices.
The specific responsibilities of this position include:
Required Education, Skills and Experience
Preferred Education, Skills and Experience
|Posted on||25 Jan 2019|
Audentes Therapeutics (NASDAQ: BOLD) is a biotechnology company committed to the development and commercialization of innovative gene therapy products for patients living with serious, life-threatening rare diseases. We believe gene therapy technology has tremendous potential as a treatment approach for many genetic diseases. We are currently conducting Phase 1/2 clinical studies of our lead product candidates, AT132 for the treatment of X-linked Myotubular Myopathy (XLMTM), and AT342 for the treatment of Crigler-Najjar syndrome. We have two additional product candidates in development, including AT845 for the treatment of Pompe disease, and AT307 for the treatment of the CASQ2 subtype of catecholaminergic polymorphic ventricular tachycardia (CASQ2-CPVT). We are a focused, experienced and passionate team driven by the goal of improving the lives of patients.
Audentes takes pride in strong, global relationships with the patient, research and medical communities, and we take equal pride in carefully selecting our colleagues. If you believe you match what we're looking for, we'd love to hear from you. Our compensation philosophy embodies what you'd expect from an innovative life sciences employer competing for the best talent available.
Listed below is a current opening for which we are seeking smart, driven, experienced, and just plain nice people to join us in realizing Audentes' mission.