Marketed Products Clinical Pharmacology Lead

Bring out the best in each other, and yourself, by working together as one

In our dynamic environment, be supported by the brightest minds working together side by side. Agile and collaborative, we work cross-functionally, as well as externally, to thrive at pace.

How we do it

Committed to living our values – they guide our behaviours, actions and decisions, everyday.

It drives us to work together as one global team to achieve our goals. A supportive place where all are encouraged and achievement is recognised. Strengthening our knowledge through constructive feedback and coaching, as well as collaborating with the best.

Why we love it

You will be valued. Not only for your unique contribution, skills and background, but because we recognise people are our greatest asset. Here we are dedicated to being a Great Place to Work.

What You’ll do

You will manage a team of Clinical Pharmacokineticists to ensure high quality and timely delivery of non-compartmental analysis deliverables to the organization. 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. You 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. Taking lead or support local/global initiatives in areas related to science, portfolio, harmonization, etc. and generally contribute to the Department.

Key Responsibilities

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 follows 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 proven experience in conducting and reporting clinical pharmacokinetic analysis
  • 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 critical 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
  • PhD degree preferred or equivalent (M.Sc./Pharm.D.) with relevant experience required

Desirable

  • A strong publication record in the area of pharmacokinetics/clinical pharmacology
  • Prior management experience

Location: Cambridge, UK

Salary: Competitive

So, what’s next?

Are you already imagining yourself joining us? Good, because we can’t wait to hear from you!

Advertising opens on 22nd April 2021 and we welcome with your application; CV and cover letter, no later than 6th May 2021

For more information please contact: alexander.doyle@astrazeneca.com

Additional information

Our Company Values & Behaviors underpin everything we do so please take a moment to familiarize yourself with them. You may also want to check out our new R&D Video showing how we turn Science into Medicines. Covid-19 Resources

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