Biogen Senior Scientist, Toxicology (Pre-Clinical Safety) in Cambridge, Massachusetts
As the Senior Scientist, Toxicology, you will provide strategic preclinical safety expertise and representation for clinical development programs from IND through post-marketing. You will also contribute to the program team’s goals and deliverables while serving as a Preclinical Safety Sub-team Leader for multiple programs. What You’ll Do: * Ensure that the preclinical safety plan for the program is aligned with the clinical development plan, applicable regulatory guidelines (ICH, FDA, GLP), modality (e.g., small molecule, biologic, antisense oligonucleotide, or gene therapy) and program objectives. * Collaborate with other functional groups (study management, pathology, clinical, regulatory, research, translational sciences, drug metabolism/pharmacokinetics (DMPK), clinical safety, CMC, etc.) on program-related tasks and objectives. * Apply a broad understanding of toxicology, pharmacology, DMPK and regulatory sciences to design all types of toxicology studies required to support clinical development and registration of biopharmaceuticals which may include safety assessment of novel device and delivery systems. * Absorb and synthesize a broad range of data from toxicology, pharmacology, and DMPK studies to complete the risk assessment, and establish safe-use conditions in humans, for novel therapies. * Prepare high quality nonclinical regulatory documents to support regulatory submissions, clinical development, and marketing authorizations globally. * Serve as a subject matter expert within their field of sub-specialization to provide input on other programs and studies, including external partnerships and due diligence reviews for in-licensing and business development opportunities. * Represent the preclinical safety function at country-specific regulatory meetings for their programs, and represent Biogen on external scientific committees and industry working groups in the areas of drug development and regulatory toxicology. * Lead or participate in Biogen subcommittees for process improvement / modernization. * Provide mentorship to less experienced toxicologists and scientists within and outside of the Preclinical Safety Department Required Skills * Ph.D. or equivalent in Toxicology or closely related field. * 7 - 9 years of combined toxicology, drug development and regulatory experience in a biopharmaceutical setting. * A high degree of familiarity with applicable regulatory guidelines (ICH, FDA, GLP, etc.) * Demonstrated experience and expertise with both GLP and non-GLP compliant in vitro and in vivo toxicology study conduct and reporting * Proven leadership, organizational and time management skills, including the ability to interact effectively with contract research laboratory personnel and internal/external experts for the conduct of toxicology studies. * Possess good communication and technical writing skills while being capable of engaging in scientific dialog among large groups of scientists, senior management, and external scientific experts. Preferred Skills: * Prior experience with regulatory agency interactions * Toxicology board certification All your information will be kept confidential according to EEO guidelines.