Development DMPK Lead (m/f/d)

1 day ago – Be among the first 25 applicants

Professional | Permanent | Full-/Part-time | Hybrid

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 life 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.

What The Job Looks Like

• Influencing project progression and regulatory submission through preclinical and clinical development.
• Lead the scientific and operational design, conduct, implementation, and analysis of non‑clinical and clinical development DMPK, ADME, DDI and Bioanalysis studies for small molecules and/or genetic medicine modalities to support the progression of development portfolio through clinical development.
• Engage with clinicians, translational sciences and development project leaders to design clinical studies based upon human PK, PKPD and ADME understanding required and oversee clinical pharmacokinetic, metabolism and DDI studies and interpretation to support project decision‑making in clinical development.
• Align with discovery DMPK and Pharmacology to ensure human PK, PKPD, dose, and DDI predictions are undertaken as appropriate for small molecules and/or genetic medicine modalities 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, as appropriate for small molecules and/or genetic medicine modalities.
• Align with pharmaceutical sciences to develop an integrated DMPK‑CMC formulation development strategy and execution supporting projects moving into and during clinical development.
• Engage with CROs and external experts regarding conduct and interpretation of both regulatory and bespoke development DMPK studies as appropriate for small molecules and/or genetic medicine modalities.
• Authoring and reviewing of pharmacokinetic and metabolism sections of regulatory documentation from pre‑FTIH through to registration.

What You’ll Bring To The Table

• Educational background in biological or pharmacological sciences or related field with significant experience (≥10 years) gained working in preclinical and clinical DMPK discipline in industry.
• Expert technical knowledge of ADME/DMPK principles, in preclinical and clinical setting for small molecules and genetic medicine modalities, and good understanding of their relationship to pharmacology and PKPD and also to non‑clinical safety evaluation.
• Ability to design, initiate and oversee preclinical development DMPK/ADME studies and clinical pharmacology studies at CROs and understanding of regulatory standard required.
• Track record of developing and applying state‑of‑the‑art DMPK technologies to drive scientific understanding and project decision‑making.
• 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.
• Experienced 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.

"DMPK sciences plays a crucial role at the interface between preclinical and clinical development. At Grunenthal we are at an exciting phase of innovation of small molecules and genetic medicines for Pain R&D. Come join us in DMPK on this journey."

Paul Morgan, the Hiring Manager