Scientific Director, Pathology

Role Summary

Biogen seeks a Director, Pathology to provide veterinary toxicologic pathology expertise across the portfolio. You will design, execute, and interpret toxicology studies, assess safety risks, and contribute to project strategy across all phases of Drug Discovery and Development and for marketed products. As part of the Nonclinical Safety team, you will collaborate with Toxicology and Study Management to enable the delivery of first-in-class treatments and therapies that improve patient outcomes.

Responsibilities

• Provide pathology expertise to the design and conduct of GLP and non-GLP nonclinical safety studies to enable progression of discovery and development programs to decision points.
• Conduct pathology peer reviews and provide expert evaluation of clinical and anatomic pathology data to inform study results and conclusions; conduct primary pathology evaluations as needed.
• Review anatomic and clinical pathology reports; review integrated toxicology reports for finalization.
• Serve as a contributing author to pathology sections of regulatory documents such as INDs, NDA/BLAs, IBs, and respond to Health Authority questions.
• Contribute to and/or lead the communication of safety study results and conclusions to program teams and internal and external stakeholders.
• Provide comparative medical perspective to drug development teams regarding the clinical relevance of findings from nonclinical safety assessment studies.
• Contribute to initiatives aimed at improving the efficiency of pathology processes and procedures, including collaborative efforts with CRO partners.
• Consult with colleagues on pathology-related results and investigate unexpected findings.
• Participate in business development and due diligence evaluations for potential in-licensing, partnerships, and acquisitions of external assets.
• Collaborate with colleagues on the design of investigative toxicology plans and studies.
• Participate in or lead Nonclinical Safety cross-functional initiatives and special purpose subteams to address emerging trends or new approaches in toxicology and pathology.

Qualifications

• DVM or equivalent; MS/PhD preferred or significant research experience in a relevant scientific discipline.
• 12+ years of veterinary anatomic pathology post-graduate experience in the biopharmaceutical or contract research industry.
• Board certification in veterinary pathology (DACVP or equivalent) required.
• Ability and experience as a toxicologic pathologist to support discovery and/or development programs.
• Experience with multiple modalities, including oligonucleotides, small molecules, biologics, and antibody-drug conjugates.
• Proven leadership, organizational, and time management skills, including the ability to collaboratively interact effectively with internal/external colleagues and experts for the review of anatomic pathology.
• Must possess good communication and technical writing skills, capable of engaging in scientific dialogue among large groups of scientists, senior management, and external scientific experts.
• Ability to express views and opinions, listen, and accept conflicting points of view.