Dmpk Project Leader
AstraZeneca AB / Biomedicinjobb / Mölndal
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hela Sverige Visa alla jobb hos AstraZeneca AB i Mölndal,
Göteborg,
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Stockholm eller i
hela Sverige 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 two motivated individuals 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. These positions are placed at AstraZeneca's dynamic R&D site in Gothenburg, Sweden. Working at AstraZeneca means being entrepreneurial, following the science, scrutinizing data and details simultaneously with holistic thinking and through teamwork make progress.
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.
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 (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.
Så ansöker du Sista dag att ansöka är 2024-07-25
E-post:
karolina.zingmark@astrazeneca.com Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-194051".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Pepparedsleden 1 (
visa karta)
431 83 MÖLNDAL
Arbetsplats AstraZeneca Göteborg
Jobbnummer 8801779
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