Senior Director, Toxicology

Build Our Future Together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Sr. Director, Toxicology to apply advanced knowledge of toxicology and pharmaceutical drug development to advance therapeutic assets through all stages of development. Working individually, or in collaboration with one or more direct reports, you will solve complex scientific and strategic/regulatory problems using extensive drug development experience, as well as state-of-the-art approaches in toxicology, pharmacology, and related disciplines. You'll communicate clearly and effectively at all levels of the organization and positively impact program strategy beyond the core discipline of Toxicology. You will also provide mentoring and management of junior scientific staff, offering relevant project-related guidance and career development, and will work with Toxicology leadership on the review and development of policies and procedures related to the conduct of toxicology research at Regeneron. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Responsibilities

• Applies advanced knowledge of pharmacology, toxicology, and related disciplines to the design and implementation of preclinical safety programs to support development of new products
• Ensures effective communication with line-management on all ongoing project activities, status, and issues relating to programs and personnel
• Writes and/or reviews relevant portions of INDs, BLAs, and other regulatory documents as needed to support program development
• Communicates effectively with global regulatory authorities in writing, by teleconference, and during face-to-face meetings as necessary
• Develops and maintains appropriate external contacts to further the advancement of development programs (e.g., contract research organizations, industry-wide scientific societies, regulatory agencies, academic research organizations)
• Provides consultative toxicology support to scientists and colleagues in other functional areas
• Maintains a deep understanding of industry trends and regulatory requirements across all major geographic regions and applicable therapeutic areas
• Contributes as Toxicology representative to corporate due diligence activities when called upon
• Contributes to the drafting and finalization of SOPs and working practices as requested
• Provides mentoring and/or supervision to junior scientific staff or direct reports, as appropriate
• May be called upon to recruit, interview, and hire new scientific staff to meet the needs of the department

Requirements

• Advanced degree (e.g., MS, PhD, DVM) in toxicology or a closely related biological science, along with 15+ years of experience, or a Master's Degree plus 20+ years, working in toxicology/safety assessment, drug development, or a contract research organization
• Significant experience or training in the development of biologic therapeutics
• Board Certification in Toxicology is desirable

Schedule

Full-time, standard business hours, with flexibility to support before- and after-hours executive meetings, town halls, and corporate events. Location: Tarrytown, NY.