Overview In this role you will lead the nonclinical safety program for R&D drug candidates, shaping toxicology and safety pharmacology strategies within a global project team. You will interact with internal and external partners and regulators to advance development plans and address safety issues, including life-cycle management and in-licensing risk assessment. This position offers exposure to diverse modalities and opportunities to influence decision-making and scientific direction. Join a mission-driven, science-led team focused on accelerating safe, innovative medicines. Compensation / Benefitsexcellent benefits and compensationhealth and wellness programsat least 14 weeks gender-neutral parental leavehigh-quality healthcareopportunities for international assignmentsinclusive workplace culture ResponsibilitiesServe as a Preclinical Safety Project Team Member on multi-functional development teams for small molecules, biologics, and other modalitiesDevelop and implement toxicology and safety pharmacology strategies for new productsSupport nonclinical safety activities across early to late-stage development and life-cycle managementWrite nonclinical summaries for regulatory documents (INDs, CTAs, NDAs/BLAs, Pediatric Investigations Plans, Scientific Advice) and assist other PTMsReview internal and external reports to provide preclinical safety perspectiveMaintain high scientific standards in nonclinical safety studies and reportingProvide internal expertise on reproductive and developmental toxicity studies (preferred)Prepare scientific publications and presentations from toxicology studiesParticipate in special projects and inter-industry working groupsContribute to design and analysis of R&D activities and external in-licensing evaluations with high scientific standards Key requirementsPhD or DVM in biochemistry, toxicology, pharmacology, biology, physiology, pathology, statistics, or related field with 12+ years in the pharmaceutical industryDemonstrated knowledge of GLP and ICH policies and regulatory nonclinical testing requirementsExperience preparing and submitting IND and CTD submissionsExperience as a GLP Study Director (preferred)Experience in ophthalmology toxicity studies (preferred)American Board of Toxicology certification (preferred)Excellent presentation skillsStrong writing abilityCross-functional collaborationGLP and ICH regulatory knowledgeNonclinical safety and toxicology study design and interpretationSafety pharmacology
Not specified in the original listing.
Not specified in the original listing.
