Director, Clinical Pharmacology, Oncology/Cell Therapy

Company: Astellas
Location: Northbrook
Posted on: May 28, 2023

Job Description:

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com. This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. Purpose and Scope:Provide global development science and strategic expertise to projects within a specific TAProvide regulatory expertise for clinical pharmacology registration within a specific TAHave thorough understanding of exploratory development, clinical methodologies, POC, and clinical endpoints within a specific TAProvide creative clinical pharmacology input for profiling of Astellas compounds to enable successful commercial differentiationAs a GCPL for phase 3 programs, will ensure efficient delivery of clinical studies within a TA, under the responsibility of CPED for registrationEssential Job Responsibilities:Provides disease area expertise and opportunities for CPED-science contributions to Core TeamOversees interpretation of complex data, provides leadership to Core Team in model-based drug development, introduces "state-of-art" translation medicine strategies, platforms and methodologies to Core TeamDefines and maintains a leading overall exploratory development and clinical pharmacology strategy that will ensure the success of Astellas. Where appropriate, prioritize studies within CPED.Contributes to the definition of world class, leading exploratory development, clinical pharmacology that will ensure success of Astellas projects.Responsible for providing scientific oversight for preparation of various sections of regulatory documents, such as IB, IMPD and CTD.Provides appropriate clinical pharmacology scientific input on licensing opportunities.Contributes to the preparation of the capacity and budgetary information related to approved development projects, maintenance and marketing support projects, infrastructural projects and/or departmental activitiesContributes to the definition, implementation and maintenance of new multidisciplinary ways of working in order to improve the efficiency and effectiveness of CPEDDisplays leadership attributes that lead to the improvement of CPED processes and level of scienceBe the Global Clinical Pharmacology Lead for in-house discovered or in-licensed compounds.This requires leading a cross functional team of 15 - 25 experts in toxicology, pharmacology, translation, Clinical Pharmacology Operations. Responsible for delivery of Exploratory Development strategies to Proof of Concept or Clinical Pharmacology strategies through registration.Quantitative Dimensions:Be involved in the design, analysis, and reporting at least 3 to 10 clinical studies per yearAs a GCPL, provide the scientific lead for a cross-functional team of 15 - 25 peopleSupervise 1-3 junior CPED scientists.Responsibilities may directly impact on strategy and efficiency of clinical development of compounds.Has responsibilities for contributing to the overall annual budgeting and assessment of resources for assigned projects for executing clinical pharmacology strategy from FIM to registrationHas responsibilities that directly impacts on strategy and efficiency of clinical development of compounds, especially in the early and late phases.Organizational Context:Reports to Senior Director or Executive Director, CPED ScienceMay have direct reporting CPED scientists who are responsible for providing contributions to individual projectsMay have functional management of scientistsThe total budget of the clinical pharmacology science section will be around 4M $USD, annually PDN-990b160a-1f2c-4ba5-8671-9d8de37a85f6

Keywords: Astellas, Chicago , Director, Clinical Pharmacology, Oncology/Cell Therapy, Healthcare , Northbrook, Illinois