Director Clinical Pharmacometrician, Early Clinical Development

Bold Disruptors. Push the boundaries of science Fearlessly break new ground

Work at the cutting-edge, where scientific innovations and an entrepreneurial spirit are the norm!

And in return… we’re looking for curious minds, comfortable taking smart risks and learning from failures.

What we do

Ultimately, our aim is to work towards a cure for some of the world’s most complex diseases. Whether that’s by shaping the patient ecosystem and focusing on outcomes, or by progressing potential medicines and accelerating their launch.

Why we love it

This is the place to make an impact. Here we ensure everyone can reach their full potential, perform at their best and make a valued contribution to the enterprise.

What You’ll do

This is a scientific job with responsibility for translational modelling, population PK, PKPD, exposure-response, disease modelling, and simulations in all clinical development phases. This person will apply state-of-the-art modelling and simulation (M&S) approaches to influence designs and internal/external decision making at the project level. The individual will support global initiatives to develop the pharmacometric field and at times mentor junior staff. The incumbent will work closely with project colleagues to ensure appropriate implementation of model based drug development (MBDD).

Accountabilities

  • Accountable for specialist data integration, analysis, interpretation, and reporting of M&S results at the project level
  • Accountable for executing state-of-the-art M&S techniques with direct value for the project
  • Use of M&S to influence study designs and go/no go decisions
  • Scientific and strategic input into pre-clinical, clinical, and post-approval development plans
  • Development of (mechanistic) drug-disease models to support projects within a specific disease domain
  • Contribute to regulatory documents and interactions (oral/written)
  • Presentation of M&S results in internal and external forum
  • Support evaluation of candidates for in-licensing
  • Contribute to internal initiatives to develop the pharmacometrics field including its processes
  • Participation in and accountability for peer review of ongoing activities, reports and presentations
  • Supervision of modelling work performed by external contractors and more junior pharmacometricians, graduate students and post-doc
  • Compliance with Good Clinical Practice (GCP) regulations as well as internal/external guidance’s

Essential

  • Significant demonstrated expertise within the field of M&S, including PK, PKPD and statistics
  • Expert knowledge of pharmacokinetics and Model-Based Drug Development (T)
  • Demonstrated broad translational and clinical development expertise and experience exemplified by extensivedrug development experience, with emphasis on Pharmacometrics.
  • Excellent oral and written communication skills
  • Demonstrated ability to identify, develop and execute strategic M&S activities at the project level
  • A demonstrated knowledge of regulatory, compliance, processes, standards and issues specific to pharmacometrics
  • Relevant disease domain knowledge
  • Relevant regulatory experience (written/oral)
  • Skilled in relevant software’s and tools within the field of M&S
  • PhD degree preferred or equivalent (M.Sc./Pharm.D.) with relevant experience required
  • Relevant regulatory experience (written)
  • Training and experience with PK and statistical software (NonMem, R, Stan, Winbugs ,SAS, Monolix , Phoenix, WinNonlin)
  • Training and experience with PK software (Phoenix, WinNonlin

Desirable

  • International scientific reputation gained from scientific publishing in the field on pharmacometrics
  • Experience in several organisations
  • Expert knowledge in pharmacology, drug targets and core disease areas
  • Good leadership capabilities, in particular with regards to influencing skills

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 25th May 2021 and we welcome with your application; CV and cover letter, no later than 7th June 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

More information about our sites:

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Apply for this job

Privacy Policy / BBSTEM Limited | Registered in England and Wales | Company No: 11127036