About the Role:
We are looking for a Sr Scientist, Toxicology who will provide strategic preclinical safety expertise and representation for clinical development programs from IND through post-marketing, within different modality types from our Cambridge, MA campus.
What You'll Do:
Represent Preclinical Safety on development program teams and contribute to the program team’s goals and deliverables and will serve as Preclinical Safety Sub team Leader for multiple programs.
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 principles of toxicology, pharmacology, DMPK and regulatory sciences to design all types of toxicology studies required to support clinical development and registration of biopharmaceuticals. This 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.
Represent the Preclinical Safety function at country-specific regulatory meetings for their programs, as appropriate.
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.
Lead or participate in Biogen subcommittees for process improvement / modernization, as needed.
Represent Biogen on external scientific committees and industry working groups in the areas of drug development and regulatory toxicology.
Who You Are:
You are capable of applying critical thinking to build toxicology strategies and overcome barriers, and working in a team matrix.
PhD with 2+ years of experience OR Masters with 6+ years of experience in toxicology, drug development and regulatory experience in a biopharmaceutical setting.
Familiarity with applicable regulatory guidelines (ICH, FDA, GLP, etc.)
Experience with both GLP and non-GLP compliant in vitro and in vivo toxicology study conduct and reporting.
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.
Good communication and technical writing skills.
Capable of engaging in scientific dialog among scientists, senior management, and external scientific experts.
Toxicology board certification
Prior experience interacting with regulatory agencies (ICH, FDA, GLP, etc.)
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
All your information will be kept confidential according to EEO guidelines.