DMPK Project Leader - Early Respiratory & Immunology

at  AstraZeneca

Are you an experienced scientist with expertise in pharmacokinetics, pharmacology and drug metabolism (DMPK)? Would you like to apply your expertise in a global company that follows the science and turn ideas into life changing medicines? Then you could be the new colleague we are looking for!
Our team is growing, and we are now looking for a motivated individual with experience in Biologics and/or small molecule drug development and PKPD, to join us as a DMPK Project Leader, from candidate selection to registration and beyond. Working at AstraZeneca means being entrepreneurial, following the science, scrutinizing data and details simultaneously with holistic thinking and through teamwork make progress.
This position will be on-site at AstraZeneca’s dynamic R&D site in Gothenburg, Sweden, and will not have the ability to be located remotely.
Respiratory & Immunology (R&I) is one of the three main therapeutic research areas within AstraZeneca. Early R&I is a global function, with research units in Gaithersburg (US), Cambridge (UK) and Gothenburg (Sweden), and delivers candidate drugs into clinical development. DMPK interacts with other functions in supporting Early R&I projects all along the value chain, from target selection all the way to market launch and Life cycle management.

With a true passion for drug discovery you will support our portfolio within the R&I therapeutic area as a subject matter expert. In the DMPK project lead role you will work collaboratively with project representatives from other disciplines. These may include biology, safety , clinical pharmacology, pharmaceutical sciences, antibody Discovery/Protein Engineering and medicinal chemistry, where your task is to influence candidate profiling by providing the necessary DMPK support for clinical investigations.
It is your responsibility to ensure delivery of all DMPK related activities throughout the value chain in accordance with regulatory requirements. These include preclinical PK experiments, in vitro ADME and biotransformation to yield pharmacokinetic understanding. Furthermore, assisting design of pharmacodynamic studies that ultimately delivers a pharmacological assessment underpinning human dose prediction and emerging clinical experience.
You will work as the development DMPK representative on project teams from candidate selection to registration and beyond. We believe that you have a solid understanding of DMPK, a working knowledge of pharmacology, and that you will be able to provide expert advice and interpretation of complex nonclinical and clinical data.

Main duties and responsibilities;

• Communicate scientific progresses both externally and internally
• Deliver DMPK input and data to projects within agreed timelines and to the right quality
• Responsible for delivering and produce the nonclinical pharmacokinetic documentation to support clinical progression
• Apply an understanding of DMPK to support/influence compound profiling, project progression and project strategy
• Define and deliver a translational quantitative PKPD strategy in projects, so that effective conclusions can be made
• Contribute to estimation of safety margins and report results and interpretations to project teams and internal governance bodies
• Responsible for leading, coordinating and engaging with R&I DMPK colleagues in project related activities
• Prepare clear presentations related to the above for internal governance bodies

Your level of professional experience will be relevant for your initial career level (Senior Scientist, Associate Principal Scientist or Principal Scientist).

Essential for the role

• PhD or equivalent experience in a relevant field
• Expert in DMPK sciences with profound knowledge of drug discovery and development processes
• Broad experience in biologics drug development (PK & Bioanalysis)
• Have PK modelling skills, experience of human PK and dose prediction, as well as an understanding of disease biology and PKPD
• Experience with regulatory submissions for biologics and/or small molecules
• Knowledge of all DMPK assays including the use of in silico tools for PK prediction
• Experience in project leadership
• Collaborative mindset
• Team player
• Proactive in providing expert support to project team and excellent communication skills