Director Toxicology - Immunology Therapeutic AreaJoin to apply for the Director Toxicology - Immunology Therapeutic Area role at NovartisThe purpose of the role is to provide nonclinical regulatory toxicology expertise on R&D project teams supporting the successful initiation of clinical trials and achievement of registration for drug candidates of various modalities.The Director level Project Team Member leads cross functional associates (i.e. PCS Target Team) to develop and implement integrated nonclinical toxicology study plans, drafts regulatory responses and all required submission documentation and manages the respective project communication strategy within PCS and Novartis.About The RoleThis hybrid role can be based in Basel or London (White City).Key ResponsibilitiesLeads PCS Target Teams to design, integrate and interpret results of nonclinical safety assessment program including impact to drug development and/or project timelineRepresents PCS on cross functional R&D project teams to design appropriately compliant and scientifically relevant nonclinical safety packageRecognize the need for a “fit for purpose and modality” nonclinical program as needed and collaborate with line functions outside of PCS to accomplish this goalParticipates in internal Novartis initiatives to improve use of nonclinical/translational safety data for drug development decisionsManages communications and builds relationships between PCS and R&D project teamsNegotiates with Global Health Authorities (HA) worldwide regarding safety issues, scientific interpretation and acceptability nonclinical safety package to support clinical trials and market approvalResponsible for authoring nonclinical safety sections of internal and regulatory documents supporting clinical development and market approvalMay evaluate in/out-licensing opportunities and carries out technical Due Diligence activities upon requestParticipates or Leads internal and/or external cross-functional groups on key initiatives focused on PCS objectives and/or current nonclinical safety topicsMentors colleagues on drug development strategy and project-related mattersEssential RequirementsMinimum of 5 years experience as a nonclinical safety Project Team member; Demonstrated experience in the preclinical development of small molecule, biotherapeutics and/or gene and cell therapies and the safety issue awareness of these modalities8+ years experience in a nonclinical drug development scientific discipline (e.g. study director, project team toxicologist or pharmacologist)Demonstrated experience in direct or written communication of strategy and data to global health authorities, supporting clinical development and market approvalKnowledge of drug development strategy for immunomodulatory drugsLeadership in cross-industry organizations (discipline-related or related to drug development)Excellent interpersonal, leadership, organizational skills (e.g. planning and time management) and teamwork skills. Excellent oral and written communication and influencing skills. Highly efficient, self-motivated, flexible and able to work independently and efficiently under time constraintsAbility to focus and work on several projects simultaneously and to effectively manage conflicting expectations from the line unit, TA Strategy team and project teams in a matrix management environmentCustomer focused thinking. Recognized ability to represent PCS on Novartis cross functional decision boards or other cross functional project teamsRecognized expertise in technical and scientific problem solving in a project driven, multi-disciplinary international environmentAbility to mentor and coachWhy Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us!Learn more here: https://www.novartis.com/about/strategy/people-and-cultureYou’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewardsCommitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/networkBenefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewardsSeniority levelDirectorEmployment typeFull-timeJob functionHealth Care ProviderIndustriesPharmaceutical ManufacturingWe’re unlocking community knowledge in a new way. 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