Project Team Member, Preclinical Safety (Respiratory / Global Health)
Location: East Hanover, New Jersey
Internal Number: 327646BR
5600! 5600 scientists working on 340 discovery programs in 8 disease areas focusing on 90 new molecular entities makes Novartis the premier place to develop your career as a pharmaceutical professional. If you are curious, scientifically minded, and want to positively impact society by speeding delivery of novel therapies to needy patients, then look no further, NIBR is the place to be.
As a Project Team Member (PTM), you will represent the Preclinical Safety (PCS) group to collaborate, align and influence on cross-functional project teams, with the goal to identify and mitigate project issues related to preclinical safety and assuring the appropriate design and execution of nonclinical safety assessment plans for projects.
Your responsibilities will include: * Represent PCS on Novartis Institutes for BioMedical Research (NIBR) and Global Drug Development (GDD) project teams in the Respiratory and Global Health portfolios to provide expert nonclinical safety input to key milestone presentations / documents in a timely manner. Identify potential project hurdles, provide solutions and establish contingency plans as necessary. * Works directly with project teams to design and interpret nonclinical safety aspects of drug development, including decision analysis, regulatory acceptability and issue resolution while maintaining alignment with the PCS TA strategy team. * Lead the development of detailed, integrated, scientifically relevant and compliant nonclinical safety assessment plans to support development / registration / renewal of drugs of various modalities. * Timely communication to PCS Therapeutic Area Head, target team and project team regarding theoretical or observed safety effects; their impact and proposed plans to address them; resource requirements to execute nonclinical safety plan. * Prepares scientific documentation relating to nonclinical safety aspects in collaboration with project team members for regulatory and internal documents such as Investigator Brochures, IND/CTAs, NDA/MAA/BLAs, Marketing Authorization renewals, Health Authority briefing books and others. Is proficient in knowing / applying respective FDA, ICH and OECD guidelines. * Responsible for non-clinical safety deliverables to PSURs, DSURs, annual reports, product renewals, Core Data Sheets and label updates including PLLR alignment for USPI of marketed products. * Clear, concise and accurate communication of nonclinical safety results and their impact to Health Authorities and investigators. Prepare appropriate responses to all Health Authority questions for both development and/or marketed products. * Conducts literature searches and analyzes relevant safety data, updates safety assessment when relevant * Prepare cytotoxicity assessment memorandums of drug substances to guide drug production aspects as well as hazardous drug substance assessment based on NIOSH criteria towards USP800. * Evaluate in-licensing opportunities, carry out Due Diligence activities, and coach other PCS associates in Due Diligence activities. * Participates in Translational Medicine or Preclinical Safety sub-teams and initiatives to drive efficiency and optimization, may also participate in external scientific organizations. * Maintains scientific and regulatory expertise in the fields of drug development and safety assessment. * Adhere in strict accord to the appropriate SOP, GLP and other guidelines.