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AstraZeneca Pharmaceuticals LP
,
Saffron Walden, Essex
Senior DMPK Project Representative (Leader)
Overview
Job Description
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity. DMPK Project Representatives occupy high profile, visible roles within Oncology R&D. We are recruiting a senior individual who has a passion for DMPK science, experience and expertise in both discovery and development DMPK support and can provide strategic insights to Governance, Drug Project and Functional leadership teams. The individual may have project accountabilities from early drug discovery towards candidate drug selection and in all clinical phases of development through to registration and life cycle management. Our 'project representatives are responsible for the overall non-clinical DMPK, including pre-clinical PK, translational PK and PK-PD, biotransformation and bioanalysis contributions to projects to fulfil internal and regulatory requirements including registration. The candidate will lead DMPK interactions with senior leaders in Oncology R&D and the full range of disciplines and functions involved, toxicology, clinical pharmacology, pharmaceutical sciences, etc. The role can be based either in Cambridge UK, or Boston, US. The Oncology DMPK team is part of Oncology R&D, a core therapeutic area for AstraZeneca. Accountabilities, what you will be doing: + You will design, commission and conduct appropriate experimental studies to support compound design, project progression and candidate selection to understand, risk mitigate and resolve project ADME challenges. + Apply an expert understanding of DMPK, physico-chemical property assays and biotransformation reactions to project chemistry and data. + You'll recommend, initiate, lead and champion new innovations that ensure cutting-edge science is applied to drug project issues. + Generate, apply and interpret predictive models for in-vitro and in-combo DMPK data to allow virtual screening of new compound designs. + You will define programmes to understand the DMPK and meet internal and regulatory requirements consistent with project milestones and timelines + Project manage deliverables from DMPK and facilitate interpretation / integration into project knowledge + Prepare the DMPK part of internal/regulatory documents (e.g. IND, IMPD, IB, NDA) + You'll represent project DMPK information in meetings and communications with authorities as well as in Due Diligence and all in-licensing activities + Provide disciplinary scientific leadership and mentorship for less experienced scientists + You will conduct collaborative research aligned to DMPK and Oncology objectives and publish research papers in internationally recognised journals. Minimum Requirements - Education, Experience and Capabilities: + PhD in Chemistry/Biochemistry/Pharmacology with significant drug discovery and development experience. + Comprehensive understanding of discovery and development DMPK including modelling and simulation and a proven ability to delineate the impact of chemical structure on measured properties. + Expert technical knowledge of DMPK and Physical Chemistry science. + Significant experience of leading and managing projects and teams to deliver scientific and functional knowledge + Significant track record of delivering DMPK scientific contributions in discovery as well as in development settings via publications in high quality peer reviewed journals. + Wide experience in pharmaceutical R&D including a knowledge of the regulatory requirements needed to fulfil the DMPK contribution to new drug submissions + Strong customer focus with the ability to have robust discussions with project leaders and key stakeholders to ensure that project, scientific and resource demands are aligned. + Bring a fresh perspective into the group and the enthusiasm to tackle new challenges and learn new skills Role can be considered at career levels F or G depending on the experience and suitability of the successful candidate, Location: Cambridge, UK or Boston, US Next steps, if you feel you are suitable for the role please apply,.