Senior Scientist (Pharmacokinetics)
Senior Scientist (Pharmacokinetics)
At AstraZeneca, we are guided in our work by a strong set of values, and we're resetting expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together. From scientists to sales, lab techs to legal, we're on a mission to turn ideas into life-changing medicines that transform lives. We need phenomenal people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. If you're swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
Designs and reviews clinical pharmacology study protocols, carries out non-compartmental pharmacokinetic analysis of clinical pharmacology studies using Phoenix/WinNonlin software along company guidelines, prepares interim, draft, and final clinical study reports. Works closely with Clinical Pharmacologists, Bioanalysts, Programmers, Clinical Research Organizations.
Major Duties and Responsibilities:
- Provides pharmacokinetic (PK) methodology for inclusion in analysis plans and clinical protocols or analysis plans
- Produce pharmacokinetic tables, figures, and listing shells are appropriate to detail the planned presentation of the results
- Create pre-lock tables, figures, and listing using non final data to allow review of their format
- Create associated datasets
- Conduct non-compartmental analyses (NCA), interpretation, and reporting of pharmacokinetic and, if needed, also for pharmacodymanic (PD) data in support of clinical studies using appropriate software like Covance’s Phoenix WinNonlin system (Pharsight)
- For interim analysis, work collaboratively with bioanalysis vendors to ensure scheduling of interim data transfers and rapid resolution of data queries
- For interim analysis perform pharmacokinetic (and pharmacodymanic) analysis and interpret the data to support dose progression
- Interpret and prepare the pharmacokinetic component of the Clinical Interpretation Meeting materials
- Write the pharmacokinetic sections of clinical study reports and, where appropriate, scientific manuscripts
- Reviews technical validity of non-compartmental analyses of performed by peers as quality control.
- Assists in development of departmental guidelines, processes, software, and training materials for non-compartmental analysis
- Depending on experience, trains and mentors other pharmacokinetists
- Supports Manager and Clinical Pharmacologists with Health Authority queries
Education Required: Bachelor’s degree in Science or Pharmacy
- Proven experience in pharmacokinetic data analysis (i.e. Phoenix WinNonlin or similar) and report writing.
- Knowledge of regulatory agency guidelines.
- 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 withoutcomplete information.
- Ability to develop and deliver effective presentations and written/oral communications.
- Thrives in a fast-paced business environment.
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.