Director, Clinical/Quantitative Pharmacology,Oncology

AstraZeneca - Gaithersburg, MD - Director, Clinical Pharmacology & Quantitative Pharmacology, Oncology At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges! We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe. The role: As the Director of Clinical Pharmacology & Quantitative Pharmacology (CPQP), Oncology, you will lead strategic and scientific responsibilities, translational modeling & simulation (M&S) and pharmacometrics activities for antibody drug conjugates (ADCs) within oncology therapy area. This person will apply state of the art quantitative approaches to influence translational/clinical strategies, clinical study designs and internal/external decision making across the ADC portfolio. You will report to the Therapeutic Area Head and will provide strategic and technical advice, support global initiatives to develop scientific and quantitative excellence in ADC area and serve as a global reviewer and mentor to junior staff. The incumbent will work closely with colleagues across AstraZeneca to ensure implementation of Model-Informed Drug Development (MIDD) and to drive a CPQP quantitative science continuum across the business. As the Director you will also have project accountabilities and work closely with clinical teams to ensure state-of-the-art Clinical Pharmacology and Model-Informed Drug Development (MIDD) approaches are implemented to influence designs and internal/external decision making. What you'll do: Accountable for leading the scientific strategy, translational modelling & simulation (M&S) and pharmacometrics activities for antibody drug conjugates (ADCs) within oncology therapy area (TA). Accountable for planning and executing state-of-the-art quantitative approaches with direct value for ADC projects cross the portfolio including go/no go decision making Support the TA Head in development of strategy, in scientific operations and business management Act as delegate for the TA Head at functional LT meetings, Clin Pharm review Board, governance, and other TA interactions, as necessary Act as project lead as required leading development and implementation of the clinical pharmacology strategy Accountable for developing a culture supportive of MIDD approaches across the TA influencing key partners, stakeholders and regulators of its value and application Contribute to ensuring a positive, collaborative culture and dialogue with key partner functions such as Early and Late TA clinical organisations, Biostatistics, DMPK and Biosciences, Translational medicine, Pharmaceutical Sciences and Regulatory affairs Providing input into pre-clinical, clinical, and post-approval development plans Accountable for oversight, support and delivery of scientific and strategic modeling work in both early and late development Support and review evaluation of candidates for in/out-licensing Contribute and lead within and cross-TA peer review Provide mentoring within and across TA's Support and contribute to the learning development, providing training and knowledge sharing Monitoring external and internal environment in terms of relevant new methodologies and applications Increase AZ profile externally in the area of CPQP by speaking at external events, by publication in recognized external journals and representing CPQP at strategic cross-industry and academic initiative and consortia as necessary Ensure CPQP contributions for the TA are aligned with current regulations and compliant with the principles of GCP and GxP. Education/Experience Requirement: PhD degree with demonstrated broad translational and clinical development experience with a minimum of 10 years international drug development (early and late clinical) Skills/Abilities: Essential Demonstrated broad translational and clinical development experience exemplified by a minimum of 10 years international drug development or equivalent experience (early and late clinical) Demonstrated solid understanding of Oncology TA with significant expertise in ADC development ranging from early to late stage Record of building successful internal/external partnership and collaboration relationships, demonstrating cultural sensitivity and awareness Experience of leading teams Strong leadership capabilities including influencing skills Experience in mentoring and developing others Conceptual, analytical and critical thinking International scientific reputation gained from scientific publishing in the field of quantitative clinical pharmacology Proven ability to identify, develop and execute strategic CPQP activities Relevant TA disease domain knowledge Relevant regulatory experience (written/oral) Expert knowledge about relevant software and tools within the field of M&S A demonstrated knowledge of regulatory, compliance, processes, standards and issues specific to CPQP Desired Experience in several organisations Benefits: AstraZeneca is a leading company in the healthcare industry, with a mission to enrich the lives of others. It's our business to support healthy living, not only for our patients, but also for our employees. Our benefits program is flexible enough to meet employees' varying needs, offers valuable choices, and is highly competitive.climate. Why AstraZeneca? At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Come join us, apply today! Where can I find out more? Our Social Media, Follow AstraZeneca on LinkedIn https://ift.tt/2D1NgWU Follow AstraZeneca on Facebook https://ift.tt/2D2j2mD Follow AstraZeneca on Instagram https://ift.tt/3iqH8I6 #Pharmacology #Oncology... - Permanent - Full-time

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