CVMD iMed - DMPK Project Leader (DPL)

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.

Description
Our DMPK Project Leaders occupy high profile and visible roles within our Cardiovascular & Metabolic Diseases Innovative Medicines unit (CVMD iMed). The role is both strategic and scientific and the DPLs are involved from target selection through candidate drug selection and all clinical phases of development through to Life Cycle Management. Our DMPK Project Leaders are responsible for the overall non-clinical DMPK, including pre-clinical PK, translational PK and PK-PD, biotransformation and bioanalysis contribution to projects from lead optimization through to Life Cycle Management to fulfil both internal and regulatory requirements.

Accountabilities/Responsibilities
-Establish and lead the core DMPK team for the delivery of the non-clinical DMPK package
-Define programmes to understand the DMPK and meet internal/regulatory requirements consistent with project milestones and timelines
-Evaluate, interpret and integrate DMPK data to drive project deliverables - including review and transition through internal governance bodies
-Project manage deliverables from DMPK IM and facilitate interpretation/integration into project knowledge
-Work collaboratively with key colleagues in the project core team as well as the DMPK Design leader, non-clinical modellers and Clinical Pharmacology and act as the bridge for exchanging knowledge, data and progress
-Initiate and coordinate activities with other AZ functions to drive the understanding of DMPK aspects of drug candidates
-Prepare the DMPK part of internal/regulatory documents (e.g. SARB, IND, IMPD, IB, NDA)
-Represent project DMPK information in meetings and communications with authorities as well as in Due Diligence and all in-licensing activities
-Publish scientific papers describing the non-clinical DMPK of their projects and provide scientific and strategic training to others

Minimum Requirements
-PhD or equivalent degree in relevant discipline
-Wide experience in pharmaceutical R&D including compiling regulatory submissions
-Significant experience of leading and managing projects and teams to deliver scientific and functional knowledge
-Ability to operate across operational, tactical and strategic elements of the business
-Broad background and comprehensive understanding of discovery and development DMPK including modelling and simulation
-Track record of delivering DMPK contribution in discovery as well as in development settings
-Cardiovascular and Metabolism disease area knowledge
-Good understanding of chemistry, biology, pharmacology and clinical pharmacology as well as translational medicine

Skills and Competencies
-Highly developed interpersonal....

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