Director, Clinical Pharmacology and Pharmacometrics

Director, Clinical Pharmacology and Pharmacometrics

Gaithersburg, United States

Additional Location: Cambridge, UK

Competitive salary and benefits

Make a more meaningful impact to patients' lives around the globe

Here you'll have the chance to create a significant difference to patients' lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines - for the world's most sophisticated diseases. Answer unmet medical needs by ground-breaking the next wave of science, focusing on outcomes and crafting the patient ecosystem.

Be part of a dedicated Research & Development team. Fuelled by our dedication to help more patients, strengthen our pipeline and grow our area.

What you'll do

The Clinical Pharmacologist is a scientific role and should work closely with the clinical Pharmacometrician, the bioanalytical lead and with the clinical team to build clinical pharmacology development programs providing a clear strategy towards the right dose to the right patients. This person will also craft, conduct, analyse and interpret results from Clinical Pharmacology studies to support decisions at study and project level.

Typical Accountabilities may include:
  • Accountable for expert data integration, analysis, interpretation, and reporting of clinical pharmacology results at the study level to support project (project team/governance)
  • Jointly accountable with the Pharmacometrician for providing a scientific justification for the dose selection/justification
  • Jointly accountable with the bioanalytical lead for selecting analytical large PK, biomarker and ADA assays
  • Participation in and accountability for peer review of ongoing activities, reports and presentations
  • Contribute to regulatory documents and interactions (written and oral)
  • Presentation of Clin Pharm results to internal and external forums
  • Contribute to internal initiatives to develop the clinical pharmacology discipline including its processes
  • Compliance with Good Clinical Practice (GCP) regulations as well as internal/external guidance's

Essential criteria
  • Late stage clinical development experience
  • Large molecule experience
  • Significant regulatory experience (written)
  • Expert knowledge of pharmacokinetics and Model-Informed Drug Development (MIDD)
  • Good knowledge in pharmacology, drug targets and core disease areas
  • Proven broad translational development expertise and drug development experience, with emphasis on Clinical Pharmacology
  • Proven ability to identify, develop and implement clinical pharmacology activities at a project level
  • Good oral and written communication skills
  • Good knowledge of global regulatory, compliance, processes, standards and issues specific to clinical pharmacology
  • PhD degree with proven experience required
  • Training and experience with PK software (Phoenix, WinNonlin)

Desirable criteria
  • Bioanalytical experience
  • Biomarker strategy experience
  • Translational science experience
  • International scientific reputation gained from scientific publishing in the field of DMPK/Clinical Pharmacology
  • M&S expertise with experience using relevant software and tools within the field of MIDD (e.g. SIMCYP, R, NONMEM, Monolix)

Why AstraZeneca

At AstraZeneca, we 're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

So, what's next?

Complete your application before the below closing date.

This role is open from 20th October 2021 until 17th November 2021.

Where can I find out more?

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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.

10001254 F DAAS R&D BioPharmaceuticals