#LI-Hybrid Internal Title: Associate Director/Senior Principal ScientistLocation: San Diego, CAWe are seeking an enthusiastic and motivated PK Sciences project team representative to develop and implement translational or clinical pharmacology strategies to support the pursuit of transformative new medicines through late clinical development. Our unique organizational structure enables colleagues to work seamlessly in the translational and/or clinical space, offering opportunities for development and bench-to-bedside-to-bench translation. The scope of the role potentially includes small molecules, biologics/therapeutic proteins, RNA based therapeutics, and/or cell therapies serving primarily the neuroscience therapeutic area. This position drives close interdisciplinary collaboration among the PK Science disciplines, Drug Disposition (ADME, BA), Modeling & Simulation (M&S), and Operations through PK science sub-teams to achieve a holistic and integrative perspective of the ADME/clinical pharmacology properties of candidates and drugs.This role reports to Neuroscience, Therapeutic Area Head in PK Sciences within Translational Medicine (TM) in Biomedical Research. PKS is a global organization situated within Translational Medicine (TM), the clinical research arm of Biomedical Research within Novartis. PK Sciences plays a pivotal role in bringing innovative medicines to patients, by building research advances to develop new therapies, bridging drug discovery and clinical application. PK Science is an enterprise-wide organization, working across both Biomedical Research and the Development organizations to advance the scientific knowledge of pharmacokinetics, metabolism and clinical pharmacology as well as disciplines as part of the research Development commercial collaboration.Key responsibilities:Independently represent the PK Sciences function in cross-functional project teams, interactions with stakeholders within the organization and interactions with regulatory agencies, as appropriateLeads a PK Science Sub team with interdisciplinary representation of the major functions from within PK Science and beyondEnsures implementation of project strategies and monitors timelines, objectives, and budgets for assigned projectsPresent projects at various institutional review and approval boardsDevelop and execute clinical pharmacology strategies, including input into nonclinical and clinical study design, and analyzing PK and PK/PD data, to support compound development from discovery through late clinical developmentProvide PK, dosage, PK/PD and M&S component of study protocols, reports, project summaries and development plans, and author pharmacokinetic/clinical pharmacology/biopharmaceutics sections of IND/IMPDs and NDA/BLAs as well as prepare appropriate responses to global Health Authority questionsIs able to provide managerial reviews for a focused project portfolioSupports strategic initiatives to create a top-performing organizationEncourages the use of artificial intelligence (AI) / machine learning (ML) approaches to enable model guided molecular design, preclinical and clinical data automation, authoring regulatory documents, and the use of predictive modelsIs a mentor to junior associates in the organizationEssential requirements:Ph.D. / Pharm.D. with relevant experience (minimum 5+ yrs) in clinical pharmacology, drug metabolism and pharmacokinetics or a related background in an industry setting.Extensive and in-depth knowledge of pharmacokinetics including, drug metabolism and PK/PD evaluation, experience in working in project teams (preferably global) as well as sound awareness of recent developments in drug development and regulatory sciences.Demonstrated success in working in a cross-functional, matrixed, project-team environment.An influential Team player and talented negotiator with strong oral and written communication skills.Ability to set priorities within and have strategic overview over a focused portfolioProven record of mentorship and/or people managementDesirable requirements:Early and late development with core clinical pharmacology expertise is preferred.Experience in Clinical pharmacology with neuroscience preferred.Hands-on project experience with Artificial intelligence (AI) / Machine Learning (ML) approaches is a plusPrior experience in clinical pharmacology, clinical development and global regulatory submissions, especially IND's/NDS's/BLA/s in neuroscience is a preferenceThis is a dual posting. The final level & title of the offer role would be determined by the hiring team based on the skills, experience & capabilities required to perform the role at the level the role has been offered.The salary for this position is expected to range between:Senior Principal Scientist: $138,600 and $257,400 per year.Associate Director: $145,600 and $270,400 per year.The salary for this position is expected to range between $132,300 and $245,700 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click here.
Novartis provides healthcare solutions that improve and extend people’s lives. We use science-based innovation to address some of society’s most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible. Our company is focused on industry-leading divisions with innovation power and global scale: pharmaceuticals, eye care and generic medicines Novartis is headquartered in Basel, Switzerland. Novartis Group companies employ approximately 120,000 associates and its products are available in more than 180 countries around the world.