Principal Scientist, Toxicology (Pre-Clinical Safety)

Job Description

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:

• Extensive experience applying in-depth theoretical knowledge from multiple areas of expertise to devise solutions to complex problems with a sustained track record of applying problem solving skills to move projects forward
• 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
• Prepare high quality nonclinical regulatory documents to support regulatory submissions, clinical development and marketing authorizations globally
• Serve as Preclinical Safety Subteam Leader for multiple and higher complexity programs
• Represent Preclinical Safety on development program teams and contribute to the program team’s goals and deliverables
• Ensure that the preclinical safety plan for the asset (or therapeutic) 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
• 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
• Leads or participates 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
• Provide mentorship to less experienced toxicologists and scientists within and outside of the Preclinical Safety Department
• 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

Qualifications

• Ph.D. or equivalent in Toxicology or closely related field
• 10-15 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.) and prior experience with regulatory agency interactions
• 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
• Demonstrated ability to mentor and develop less experienced toxicologists and preclinical safety scientists

Additional Information

All your information will be kept confidential according to EEO guidelines.