Senior Director, Toxicology

Job description

Overview The Senior Director, Toxicology provides strategic scientific leadership for nonclinical safety across multiple research and development programs. As a subject matter expert, this individual leads the development and execution of integrated nonclinical safety strategies, working independently and, where applicable, through direct reports. This role shapes nonclinical development strategy within or across therapeutic areas and provides scientific oversight for the design, conduct, interpretation, and reporting of GLP and non-GLP toxicology studies conducted at contract research organizations. The Senior Director partners with cross-functional teams and senior leaders to evaluate complex scientific and regulatory issues and inform program and portfolio decisions from discovery through registration. The successful candidate will bring scientific rigor, sound judgment, and a collaborative approach to advancing the quality and safety of investigational therapeutics. This position is hybrid onsite and will be primarily located in Cambridge, MA . Relocation may be considered for the right candidate. Key Responsibilities • Lead integrated, phase-appropriate nonclinical safety strategies across multiple development programs or a therapeutic area or platform, working independently and, where applicable, through direct reports. • Serve as the senior Toxicology and early development representative on cross-functional teams, providing scientific and strategic leadership for development candidates from discovery through registration. • Serve as a recognized scientific resource within Toxicology and across R&D, guiding the evaluation, integration, and communication of nonclinical risks, mitigation strategies, and potential clinical relevance. • Provide strategic direction across nonclinical safety assessment, including investigative and general toxicology, safety pharmacology, developmental and reproductive toxicology, and carcinogenicity evaluations, as appropriate. • Provide scientific leadership for the design, conduct, interpretation, and reporting of GLP and non-GLP toxicology studies conducted at contract research organizations, in partnership with the study monitoring group. • Maintain current knowledge of industry trends and global regulatory requirements to support the delivery of scientifically rigorous nonclinical safety packages for regulatory submissions, including INDs, CTAs, NDAs, BLAs, and MAAs. • Represent Toxicology in interactions with global health authorities, as appropriate. • Translate complex nonclinical findings into clear scientific and business considerations that inform program and portfolio decisions. • Recruit, onboard, mentor, and develop scientific talent, as appropriate, while fostering an inclusive, collaborative, and high-performing environment. • Partner with Early Development and Toxicology leadership to strengthen scientific practices, policies, and procedures governing toxicology research. • Maintain clear communication with leadership regarding program activities, scientific risks, resource considerations, and team priorities. Required Qualifications • PhD in Toxicology or an advanced degree in a related scientific discipline. Board certification ideal. • Twelve (12) or more ears of relevant pharmaceutical or biotechnology industry experience supporting nonclinical drug development from discovery through registration. • Demonstrated ability to independently lead complex development programs and influence scientific, program, and portfolio decisions in a matrixed organization. • Deep expertise in nonclinical safety assessment across the drug development lifecycle, including the development and execution of strategies supporting global regulatory submissions. • Extensive knowledge of applicable global regulatory guidance and standards, including FDA GLP, OECD, and ICH requirements. • Experience selecting, engaging, and providing scientific oversight of contract research organizations. • Ability to integrate and interpret complex data across toxicology, pathology, DMPK, safety pharmacology, and related disciplines and to develop thoughtful solutions when results are ambiguous. • Excellent written, verbal, and presentation skills, with the ability to communicate