Biogen is searching for a Director of Development Toxicology. The primary responsibility of this position is to manage the Development & Marketed Products Portfolio within the Preclinical Safety Department, and to lead a team of Toxicologists who are responsible for supporting these programs. The scope of responsibilities includes decisions related to nonclinical safety strategy and testing plans, design and conduct of regulatory compliant nonclinical safety studies, nonclinical safety regulatory submissions, and associated interactions with regulatory agencies.
Responsibilities for the role are as follows:
Leadership and management of the Development Toxicology Group within the Preclinical Safety Department, including staff performance management and talent development
Accountable for all aspects of the nonclinical safety and regulatory strategies for development programs and marketed products which are executed by the program toxicologists
Responsible for ensuring the effectiveness of the Preclinical Safety sub-teams which manage the operational execution of the nonclinical safety strategy for each program
Represents Preclinical Safety on relevant internal committees (e.g., Clinical Trial Review Board, Safety Monitoring Committee) and external scientific committees and industry working groups in areas relevant to drug development and regulatory toxicology
Responsible for ensuring effective interactions between Preclinical Safety and key stakeholder groups within and outside of Biogen, including Quality Assurance, Global Medical Safety, Regulatory, Clinical, Pharmaceutical Operations & Technologies, and our co-development partners
Core member of the Preclinical Safety Leadership Team, contributing directly to achieving the vision, mission, goals, and organizational development for the overall department
Leads initiatives to improve/modernize processes, ensure industry best practices, and optimize partnerships with internal and external stakeholder groups.
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 managing doctoral level staff in a preclinical safety setting
Demonstrated ability to lead and manage a diverse group of toxicologists, including mentorship and development at all stages of their career.
Experience working effectively with other leaders and operational staff in a matrixed organization
16+ 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.
Ph.D. in Toxicology, or closely related field.
Toxicology board certification preferred.