Senior Scientist Clinical Pharmacokinetics Full-time

Senior Scientist Clinical Pharmacokinetics

Are you ready to follow the science and explore new frontiers in clinical pharmacokinetics? As a Senior Scientist in Clinical Pharmacokinetics, you will design and review clinical pharmacology study protocols, conduct non-compartmental pharmacokinetic analyses using Phoenix/WinNonlin software, and prepare comprehensive clinical study reports. Collaborating closely with Clinical Pharmacologists, Bioanalysts, Programmers, Statisticians, and Clinical Research Organizations, you will play a pivotal role in preparing regulatory submissions and documentation related to non-compartmental pharmacokinetics. Join us in our mission to unlock the power of science and make a difference in patients' lives.

Accountabilities:

– Provide pharmacokinetic (PK) methodology for inclusion in analysis plans and clinical protocols or analysis plans.

– Produce pharmacokinetic tables, figures, and listing shells to detail the planned presentation of results.

– Review draft tables, figures, and listings to finalize their format.

– Create associated datasets.

– Conduct non-compartmental analyses (NCA), interpretation, and reporting of pharmacokinetic and pharmacodynamic (PD) data using appropriate software like Covance's Phoenix WinNonlin system (Pharsight).

– Collaborate with bioanalysis vendors for interim analysis to ensure timely data transfers and resolve data queries.

– Perform pharmacokinetic (and pharmacodynamic) analysis for interim analysis to support dose progression.

– Interpret and prepare the pharmacokinetic component of Clinical Interpretation Meeting materials.

– Write the pharmacokinetic sections of clinical study reports and scientific manuscripts.

– Review technical validity of non-compartmental analyses performed by peers as quality control.

– Assist in developing departmental guidelines, processes, software, and training materials for non-compartmental analysis.

– Train and mentor other pharmacokinetists based on experience.

– Support Manager and Clinical Pharmacologists with Health Authority queries.

– Prepare submission documentation and other documents for Health Authorities related to non-compartmental pharmacokinetic analyses.

Essential Skills/Experience:

– Bachelor's degree in Science or Pharmacy

– 6-10 years experience in pharmacokinetic data analysis (i.e. Phoenix WinNonlin or similar) and report writing.

– Knowledge of regulatory agency guidelines.

– Effective time management and organizational skills.

Desirable Skills/Experience:

– Experience with PK-PD modeling

– Team player works with others respectfully and cordially.

– The ability to adapt, work through conflicts, and persuasively influence outcomes.

– Effectively cope with change and is comfortable changing direction and acting without complete information.

– Ability to develop and deliver effective presentations and written/oral communications.

– Thrives in a fast-paced business environment.

– Good oral and written English language fluency.

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.

At AstraZeneca, we are driven by our passion for science and our commitment to making a difference. We are dedicated to treating, preventing, modifying, and even curing some of the world's most complex diseases. By fusing data and technology with scientific innovations, we aim to achieve breakthroughs that positively impact billions of patients worldwide. Our inclusive environment encourages collaboration across academia, biotechs, and industry, allowing us to create swift impacts on disease. Here, curiosity thrives as we explore without limits, empowered to make bold decisions.

Ready to make an impact? Apply now to join our team at AstraZeneca!