We are looking for a Principal 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:

The primary responsibility of this position is to provide strategic preclinical safety expertise and representation for clinical development programs from IND through post-marketing, and includes the following job duties:

·       Represent Preclinical Safety on development program teams and contribute to the program team’s goals and deliverables. 

·       Serve as Preclinical Safety Subteam 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 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. This may include safety assessment of novel device and delivery systems.

·       Able to 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. 

·       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.

·       May lead or participate in Biogen subcommittees for process improvement / modernization, as required.

·       May represent Biogen on external scientific committees and industry working groups in the areas of drug development and regulatory toxicology.

·       May provide mentorship to less experienced toxicologists and scientists within and outside of the Preclinical Safety Department

• 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.); prior experience with regulatory agency interactions desired.
• 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.
• Must possess good communication and technical writing skills.  Capable of engaging in scientific dialog among large groups of scientists, senior management, and external scientific experts.
• Toxicology board certification preferred.  

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.