Associate Director, PKPD / Pharmacometric Data Programming
Job Title: Associate Director, PKPD / Pharmacometric Data Programming
Career Level - E
Introduction to Role:
Are you ready to make a significant impact in the world of drug development? We are seeking an Associate Director for PKPD / Pharmacometric Data Programming. This role focuses on all aspects of data preparation, programming, validation, and diagnostics to support Pharmacometric and clinical pharmacology analyses at the study and project levels. You will be instrumental in influencing critical decision making throughout all phases of drug development and regulatory interactions.
Accountabilities:
As an Associate Director, you will be accountable for expert data integration, manipulation, and preparation results at the study and project level. You will execute state-of-the-art data preparation techniques with direct value for the study and/or project. Your responsibilities will include collating, cleaning, and preparing analysis-ready data for Pharmacometric Modeling and Simulation (M&S) software (e.g. NONMEM) to influence study designs and go/no-go decisions. You will also contribute to regulatory documents and interactions, internal initiatives to develop the Pharmacometric discipline, and compliance with Good Clinical Practice (GCP) regulations.
Essential Skills/Experience:
- Proficient oral and written English communication skills
- Demonstrated expertise in data preparation and programming to support Pharmacometric Modeling and Simulation (M&S) software (e.g. NONMEM, Monolix, R, Matlab)
- Strong SAS/R programming skills
- Expert knowledge of data preparation and programming practices (CDISC, SDTM, ADaM)
- Demonstrated data programming and clinical development expertise
- Good knowledge of global regulatory, compliance, processes, standards
- Bachelor’s degree MS preferred with relevant experience required
- Relevant regulatory experience
- Varied programming languages (SAS, R, Python)
- Experience in early and late-stage drug development
- Knowledge in pharmacology, drug targets and core Therapy areas (e.g. Oncology, Respiratory, Renal Metabolism etc.)
- Quantitative/Scientific background (Statistics, Engineering, Biological Science)
Desirable
- Scientific publishing in the field on pharmacometrics
- Project Management Skills
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Why AstraZeneca?
Join our Biopharmaceuticals R&D team and be part of a team where you are empowered to follow the science. At AstraZeneca, we are unlocking the power of what science can do. We are working towards treating, preventing, modifying and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.
Ready to make a difference? Apply today and join us in pushing the boundaries of science to deliver life-changing medicines!
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.
