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Marketed Products Clinical Pharmacology Lead

Lieu Varsovie, Voïvodie de Mazovie, Pologne Job ID R-087456 Date de publication 08/05/2020

This is a manager role for a non-compartmental pharmacokinetic group and also includes individual contributor project accountabilities. The role also has responsibilities to contribute to or lead initiatives related to scientific, strategic and/or improvement initiatives, either at the Therapy Area (TA) or functional level. The individual will be part of a dynamic, innovative, business-focused, and science-driven team. This individual will report to the Therapy Area (TA) Lead for Marketed Products and Lifecycle Management and work closely with members of all therapy area teams in the CPQP organisation to ensure consistent and valued CPQP contributions across the portfolio.

The individual will manage a team of Clinical Pharmacokineticists to ensure high quality and timely delivery of non-compartmental analysis deliverables to the organization. The individual will be accountable for maintaining the information technology infrastructure from a business (not technical) perspective, maintaining pharmacokinetic software, SOPs, guidances, and templates that their team uses to deliver their analysis in a compliant and consistent manner. The individual will also have project accountabilities for marketed products in all therapy areas and work closely with clinical and regulatory teams to ensure state-of-the-art Clinical Pharmacology and Model-Informed Drug Development (MIDD) approaches are implemented to support AstraZeneca’s mature brands. The individual will also lead or support local/global initiatives in areas related to science, portfolio, harmonization, etc. and generally contribute to the Department.

Typical Accountabilities

  • Non-Compartmental Pharmacokibnetics Team Manager

  • Lead a team that delivers quality non-compartmental clinical pharacokinetic input to clinical studies from first-in-huamn studies to life-cycle management (LCM) and be responsible for the recruitment, retainment and development of these team members
  • Ensure CPQP contributions for their team are aligned with current regulations and compliant with the principles of GCP and GxP.
  • Working with Information Technology and other business partners, maintain the information technology infrastructure from a business (not technical) perspective, maintaining internal non-compartmental pharmacokinetic software, internal SOPs, guidances, and templates.
  • Marketed Products Clinical Pharmacology Lead

  • Scientific and strategic input into Marketed Products Clinical Pharmacology responses to Regulators
  • In close collaboration with the CPQP Marketed Products and Lifecycle Managament Head and the TA team be accountable for providing flexible, competent and responsive service with appropriate quality and speed according to business needs; continuously enhance productivity and cost efficiency where relevant
  • Act as project clinical pharmacologist as required
  • General Clinical Pharmacology Support

  • Support evaluation of candidates for in/out-licensing
  • Contribute to within and across-TA peer review and mentoring
  • Support and contribute to the learning development of staff 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 and by publication in recognized external journals

Essential

  • Demonstrated at least 5 years experience in conducting and reporting clinical pharmacokinetic analysis
  • PhD degree preferred or equivalent (M.Sc./Pharm.D.) with relevant experience required
  • Demonstrated clinical development experience in drug development (early and/or late) or equivalent life science experience
  • Works independently, drives performance, holds self and others accountable
  • Strong management/leadership capabilities
  • A demonstrated knowledge of regulatory, compliance, processes, standards and issues specific to non-compartmental analysis
  • Relevant regulatory experience (written/oral)
  • Experience in mentoring and developing others
  • Conceptual, analytical and strategic thinking
  • Record of building successful internal/external partnership and collaboration relationships, demonstrating cultural sensitivity and awareness
  • International scientific reputation gained from scientific publishing in the field of quantitative clinical pharmacology
  • Demonstrated ability to identify, develop and execute strategic CPQP activities
  • Demonstrated proficiency in written and spoken English language

Desirable

  • ·A strong publication record in the area of pharmacokinetics/clinical pharmacology

  • Prior management experience



AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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