Director, Safety Scientist

Role: Director, Safety Scientist, supporting clinical safety assessments for biopharma compounds, primarily in oncology or cancer-related areas. Responsibilities include leading safety signal detection and evaluation, assessing safety data, preparing safety communications, and supporting regulatory submissions such as INDs, NDAs, and safety reports (e.g., DSURs, PBRERs). The role involves collaboration with Product Safety Leads, Safety Scientists, and cross-functional teams, with a focus on pharmacovigilance, risk assessment, and regulatory interactions. The position also supports clinical trial safety monitoring, safety data review, and health hazard evaluations. It requires applying scientific expertise to safety signal management, authoring safety sections of regulatory documents, and leading safety governance meetings. The role may involve managing direct reports and influencing internal/external stakeholders, including regulatory agencies. Qualifications: PharmD, NP, RN, or PhD in medical or biological sciences with 8+ years of experience in safety science, clinical development, or pharmacovigilance; MD plus clinical training and 4+ years clinical experience is preferred. Skills include advanced proficiency with safety databases (Argus), MedDRA, signal management tools, and data analysis software (Spotfire, PowerBI). Experience in global regulatory requirements, pharmacovigilance principles, and medical safety assessments is essential. Travel is minimal (<10%), and the work setup is not explicitly specified but likely global and matrix-based. High-value specifics include a focus on oncology, biologics, and regulatory safety oversight.