Job Description

PK Sciences (PKS) offers you this opportunity to make an impact, where 450 projects are straddling discovery through development. PKS is a global organization of about 300 associates, situated within Translational Medicine (TM), in Novartis Institutes of Biomedical Research (NIBR). It is an enterprise organization, unique within pharmaceutical industry, where one can work across both NIBR (Research) and the Global Drug Development (GDD) organizations to apply the scientific knowledge of pharmacokinetics, pharmacodynamics, metabolism and clinical pharmacology in advancing the drug candidates from discovery and clinical development through approval and beyond. Novartis portfolio consists of projects using several therapeutic modalities including small molecules, biologics, gene therapy and cell-based therapies. We are active in multiple therapy areas like Oncology, Autoimmune Diseases, Neuroscience, Musculoskeletal Diseases, Ophthalmology, Respiratory, Cardio-metabolic and Infectious diseases. We collaborate across scientific and organizational boundaries, with a focus on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients. Your responsibilities include, but are not limited to: . Independently represents PK Sciences a core member of discovery, translational medicine and global project teams or acts as LF / Lab Head. Participates or leads PKS sub-team to define PKS strategy for compound progression and development. . Manages study timelines, objectives and budgets, ensures accuracy of project progress in company tracking tools. . Responsible for the timely and effective communication of data, strategy, results, impact to the project teams. Aligns plans and strategies with sub-teams, project teams, manager and leadership team. . Analyze and interpret PK/TK/PD/IG and/or absorption, distribution, metabolism & excre-tion (ADME) data generated during discovery, early and full development present results to the program. Proactively identifies potential project hurdles, provides solutions and contributes to con-tingency plans. . Authors and prepares key pre-clinical and clinical, and regulatory documents including, but not limited to: clinical study protocols, clinical study reports, modeling reports, investi-gator brochures, IND / IMPDs and NDAs within agreed timelines, and meeting all regula-tory requirements. . Actively participates in cross-departmental teams, department-wide initiatives and work streams. Provide PK Sciences expertise on due diligence and prepare appropriate documentation. . Publishes internally or externally as main contributor to enhance Novartis and PK Sciences visibility. . May mentor and train other PK Science Associates. Completes all required organizational trainings and requirements according to corporate timelines. Adhere in strict accord to the appropriate SOP and GxP guidelines. Diversity & Inclusion / EEO Minimum Requirements . 8 + years of experience in drug discovery, development or a relevant environment (e.g. Clinical Pharmacology or Drug Metabolism and Pharmacokinetics). . Extensive and in-depth knowledge of scientific discipline especially in drug metabolism and pharmacokinetics. . Demonstrated success of working in cross functional project teams (preferably global) and sound awareness of recent developments in drug development sciences . . Knowledge of regulatory requirements and experience in dealing with regulatory authorities. . Proficient with full range of techniques used in job and core area . Extensive library research skills. Working knowledge of tools and processes used in drug design and development. . Sound and robust list of scientific publications. WHY NOVARTIS 769 million lives were touched by Novartis medicines in 2020, and while we\'re proud of this, we know there is so much more we could do to help improve and extend people\'s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what\'s possible, when we collaborate with courage to aggressively and ambitiously tackle the world\'s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis! Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse team\'s 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:

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