Company Profile

OverviewThe Head of Pharmacovigilance and Risk Management provides strategic leadership and tactical oversight of the clinical safety department. Serves as subject matter expert for all medical and safety needs. Oversees submission for safety reports, interacts with regulatory authorities, monitors safety across all programs. Reports to the CMO. ResponsibilitiesGlobal management of departmental operations (resourcing, operating procedures, training, technology, budget, etc.). Maintains ...

OverviewCelldex is a clinical-stage biotechnology company dedicated to developing novel antibody-based treatments that improve the lives of patients with allergic, inflammatory and autoimmune disorders. As our pipeline progresses toward major regulatory milestones, we are seeking an experienced and strategic Associate Director, Regulatory Affairs to lead global regulatory efforts across early and late-stage programs. This role will be instrumental in shaping and executing regulatory strategies ...