Overview
Interact with multi-disciplinary teams during due diligence procedures to critically assess nonclinical safety programs for external drug candidates and provide line function aligned recommendations for follow-up actions
Full job description
Description
Full Job Description
Interact with multi-disciplinary teams during due diligence procedures to critically assess nonclinical safety programs for external drug candidates and provide line function aligned recommendations for follow-up actions
Key responsibilities
Key responsibilities:Conduct due diligence activities under compressed timelines with the ability to rapidly identify key issues followed by clear and comprehensive communication of risks, issues, gaps and conclusions to the due diligence team.Lead PCS cross-disciplinary teams as required to further evaluate potential nonclinical safety issues or findings.Work in close collaboration with the PCS TA Head and Global Head of PCS to ensure that nonclinical safety assessments, mitigation strategies and development plans are fully aligned within the line functionWork in close collaboration with the Translational Medicine External Program (TEP) Team to support further implementation of the TEP model and improve processes and procedures.Support Biomedical Research Integration Office (BRIO) integration activitiesSought-after mentor and role model for talent development, coaching, and performance discussions across the organizationKey Performance Indicators (Indicate how performance for this role will be measured)Recognized within Novartis for scientific and regulatory expertise in drug development and safety assessmentRecognized for leadership potentialExtensive experience in nonclinical safety development strategies and evaluation of drug candidates from diverse modalities (including low molecular weight molecules, biologics, oligonucleotides, gene therapy and radionucleotides)Familiar with R&D disciplines beyond nonclinical safety. Broad knowledge of regulatory guidelines, Quality Management processes and animal welfare requirements relevant for nonclinical safety development programsDemonstrated ability to communicate scientifically sound nonclinical safety conclusions and mitigation strategies to due diligence, PCS management and Novartis leadership teamsResponsible for authoring the nonclinical safety sections of due diligence assessment reports highlighting key risks, issues, gaps together with potential mitigation strategies and conclusionsProvide PCS development strategy and resourcing requirements in the clinical development planProvide input to handover package to specify vendor requirements for transfer of PCS methodologies/data/samples and reports to Novartis after deal signature.Work closely with BRIO to ensure smooth handover to the assigned PCS PTM and project team during integration of assetsMaintain strict adherence to confidentiality and legal requirementsMentor colleagues on drug development strategy and project-related mattersEssential Requiremernts:PhD in pharmacology, toxicology or a related biological science; DVM, PharmD, M.S. or equivalent with appropriate training, a strong biological background or equivalent work experience. Fluent English Minimum of 8 years of experience as a full-time nonclinical safety expert in the pharmaceutical industryExcellent oral and written communication abilitiesAble to independently anticipate and analyze issuesDemonstrated ability to manage multiple projects simultaneously
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