Job Description

What youll do:

• Accountable for all aspects of the nonclinical safety and regulatory strategies for their development programs and marketed products
• Responsible for ensuring the effectiveness of their Nonclinical Safety sub-teams (represented by toxicology, pathology, study management, DMPK, and CMC) which manage the operational execution of the nonclinical safety strategy for each program
• Collaborate with other functional groups (study management, pathology, clinical, regulatory, research, translational sciences, DMPK, clinical safety, CMC, etc.) and external partners on program-related tasks and objectives
• Leads initiatives to improve/modernize processes, develop best practices guidelines, validate new methods and technologies, and optimize partnerships to facilitate portfolio advancement.
• Represents Biogen on external scientific committees and industry working groups in the areas of drug development and regulatory toxicology.
• Provides mentorship to less experienced toxicologists and scientists within and outside of the Nonclinical Safety Department
• 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.

• In-depth knowledge and expertise with both GLP and non-GLP compliant in vitro and in vivo toxicology study design, conduct, reporting and regulatory submissions.
• A high degree of familiarity with applicable regulatory guidelines (ICH, FDA, GLP, etc.) and experience with regulatory agency interactions.
• Experience working effectively with other leaders and operational staff in a matrixed organization
• Ph.D. in Toxicology, or closely related field.
• Toxicology board certification preferred.
• 12-15 years of regulatory toxicology and drug development experience in the biopharmaceutical industry.
• Proven leadership, organizational and time management skills, including the ability to lead teams, delegate, and interact effectively with internal/external experts for the conduct of toxicology studies, risk assessment and drug development. 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.

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