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Development DMPK Lead (m/f/d)

Country:  Europe
City:  Europe
Department:  Research & Development
Job ID:  38955

 

If you’re passionate about changing lives for the better, this is the opportunity you’ve been waiting for. In Research & Development, we’re continuously exploring innovative new treatment options to make a stronger, more positive impact on the lives of the patients we serve. You’ll work with talented colleagues in a state-of-the-art Research & Development environment, developing innovative medicines that change the live of patients for the better and help us make progress towards our vision of a world free of pain. Join us today, and discover the difference you can make.

 

As a DMPK specialist you will have the opportunity to impact the portfolio throughout the project lifecycle from early discovery through to clinical development recognising the influence DMPK has on project progression. You will be a key member of the DMPK team and help shape the DMPK strategy across the project lifecycle. With a particular focus on drug development, you will provide expert DMPK understanding at the interface with drug discovery, non-clinical safety, biopharmaceutics, translational sciences and clinical pharmacology.

 

What the job looks like

Each day you'll enjoy a variety of challenges, such as:

  • You will have the opportunity to influence DMPK success through interaction with Grünenthal R&D teams, external collaborators and vendors. These interactions will occur across multiple locations and countries and thus location of the role is flexible.
  • Being the DMPK representative on development project teams influencing project progression and regulatory submission through preclinical and clinical development.
  • Lead the scientific and operational design, conduct, implementation, and analysis of non-clinical development DMPK, ADME, DDI and Bioanalysis studies to support the progression of development portfolio into early clinical development using state-of-the art computational, in vitro and in vivo technologies.
  • Align with discovery DMPK and Pharmacology to ensure human PK, PKPD, dose and DDI predictions are undertaken to best practice standard for regulatory submission and clinical study design.
  • Align with non-clinical safety at the DMPK-Safety interface through PK and metabolism understanding in toxicology species and conduct investigative DMPK work as needed to support safety de-risking.
  • Align with non-clinical safety and pharmaceutical sciences to develop an integrated preclinical development strategy and execution supporting projects moving into Phase 1 clinical development.
  • Engage with clinicians, translational sciences and development project leaders to design clinical studies based upon human PK, PKPD and dose predictions and once in clinical development, oversee clinical pharmacokinetic, metabolism and DDI assessment and interpretation to support project decision-making.
  • Engage with CROs and external experts regarding conduct and interpretation of both regulatory and bespoke development DMPK studies.
  • Authoring and reviewing of pharmacokinetic and metabolism sections of Regulatory documentation from pre-FTIH through to registration.
  • Keep abreast of DMPK science through literature and conferences and look to publish work where possible.

 

What you'll bring to the table

To make the most of this role and truly thrive, you should have:

  • Educated in biological or pharmacological sciences or related field with significant experience (≥10 years) gained working in DMPK discipline in industry.
  • Expert technical knowledge of ADME/DMPK principles, in preclinical and clinical setting, and good understanding of their relationship to pharmacology and PKPD and also to non-clinical safety evaluation.
  • The ability to design, initiate and oversee development DMPK/ADME studies at CROs and understanding of regulatory standard required.
  • A track record of developing and applying state-of-the-art DMPK technologies to drive scientific understanding and project decision-making.
  • A track record of interpretation and reporting of DMPK studies to support decision making. Track record of writing and reviewing Pharmacokinetics and Metabolism sections for regulatory submission.
  • Relevant experience working as a DMPK representative on development project teams.
  • Experiences in pharmacokinetic analysis with experience in use of software such as Phoenix/WinNonLin PK. A good understanding of PBPK modelling and industry standard software to use.
  • A good understanding of PKPD principles and the use of PKPD/QSP in translation to clinical patient setting.
  • Excellent written and communication skills.
  • Demonstrated ability to work in a matrix environment, multi-task, meet deadlines and deal with evolving priorities. You have a curious mindset and are comfortable challenging the status quo and following the science


 

About Grünenthal

Grünenthal is a global leader in pain management and related diseases. As a science-based, privately-owned pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide. Our purpose is to change lives for the better – and innovation is our passion. We are focussing all of our activities and efforts on working towards our vision of a world free of pain.

Grünenthal is headquartered in Aachen, Germany, and has affiliates in 29 countries across Europe, Latin America and the US. Our products are available in more than 100 countries. In 2020, Grünenthal employed around 4,500 people and achieved sales of € 1.3 bn.

Your HR contact:
Simona Frings

Meet our teams
Website: careers.grunenthal.com
LinkedIn: Grunenthal Group
Instagram: @grunenthal

Meet our teams
Website:
careers.grunenthal.com
LinkedIn:
Grunenthal Group
Instagram:
@grunenthal

Apply now

Apply for Job