Senior Director, Toxicology

Regeneron Pharmaceuticals•Tarrytown, GA

23h•$242,000 - $403,300•Onsite

About The Position

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.

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

Nice To Haves

Board Certification in Toxicology is desirable

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