DMPK Project Leader

7 days ago


Gothenburg, Sweden AstraZeneca Full time



Our team is growing, and we are now looking for a motivated individual with experience in Biologics and/or small molecule drug development and PKPDto 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.


What you’ll do?
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.

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

Why AstraZeneca? 
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

Work policy
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give 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. 
 
What's next
If you are ready to make a difference - apply today, and we'll make it happen together We welcome your application until August 31, 2024 . For more information about the position, please contact recruiting manager Lassina Badolo at

Note:

Where can I find out more?
Our Gothenburg site:
Life in Gothenburg:
Culture and atmosphere of the Gothenburg site:
Relocate to Gothenburg:

Date Posted

26-juni-2024

Closing Date

31-aug.-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

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