Associate Director / Director, Toxicology
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. Summary Leverages broad industry experience, technical expertise and strategic leadership to design and effectively execute research and development programs with little to no guidance. Works in collaboration with other members of the toxicology group to develop policies and procedures related to the conduct of toxicology research. Ensures toxicology research complies with protocols and standard operating procedures. Provides support for regulatory activities. Manages and mentors less senior toxicology personnel. Responsibilities . Apply advanced knowledge of toxicology and related disciplines to the design and implementation of research programs to support development of new products . Interface with colleagues across the organization to support program planning and execution . Maintain a deep understanding of industry trends and regulatory requirements across all major geographic regions . Design and execute overall preclinical safety programs to support clinical trials and regulatory submissions . Write and/or review relevant portions of INDs, BLAs, informed consent forms and other regulatory documents as needed to support program development . Communicate effectively with global regulatory authorities in writing, by teleconference and during face-to-face meetings as necessary . Develop and maintain appropriate external contacts to further the advancement of development programs e.g , contract research organizations, industry-wide scientific societies, regulatory agencies, academic research organizations . Anticipate future toxicology research needs and initiate the development and implementation of new approaches . Design and develop company policies and practices . Lead operational activities as appropriate . Make decisions and implement policies that affect areas of the company beyond Toxicology . Interface with senior management to provide and obtain information and to build consensus regarding project direction . Supervise, direct and mentor junior-level staff #LI-GP1. Education . PhD in Toxicology or related discipline. Experience . 12+ years of relevant experience in toxicology and pharmaceutical drug development . Significant experience or training in the development of antibody therapeutics . Board Certification in Toxicology is desirable . Management experience preferred This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business. To all agencies . Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.