DMPK-PD Project Leader

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In Roche’s Pharmaceutical Research and Early Development organisation (pRED), we make transformative medicines for patients to tackle some of the world’s toughest unmet healthcare needs. At pRED, we are united by our mission to transform science into medicines. Together, we create a culture defined by curiosity, responsibility, and humility, where our talented people are empowered and inspired to bring forward extraordinary life-changing innovation at speed.

At the intersection of science and innovation, pRED’s Pharmaceutical Sciences (PS) organisation enables the discovery and development of safe and effective therapeutics at optimal doses in relevant populations with a vision to power translation, continuously improve the accuracy of our predictions and accelerate the development of tomorrow's medicines. By seamlessly integrating our three core pillars—Translational Safety, Translational Pharmacology, and Biomarkers—we drive end-to-end asset development across the entire value chain, from target assessment to on-market support.

Our mission is to continuously improve predictive accuracy, optimise dosing strategies for the right patient populations, and accelerate the development of tomorrow's safe and effective therapeutics.

As an experienced DMPK-PD Project Leader within the Translational DMPK-PD Group, you will be pivotal in ensuring the right drug is delivered at the right dose, safely and efficaciously, to patients. You will lead nonclinical and translational strategies, collaborating across therapeutic areas to transform scientific hypotheses into groundbreaking clinical candidates.

Your Impact & Responsibilities:

• Strategy & Design:
  Define and lead drug design and optimisation strategies and compound profiling integrating cutting-edge Drug Metabolism and Pharmacokinetics (DMPK) principles, with a strong focus on target biology validation and translational PK/Pharmacodynamics (PD) concepts.

• Translational Expertise:
  Serve as the subject matter expert, guiding early discovery teams in developing sophisticated translational strategies for clinical evaluation of target modulation, leveraging deep biochemical and pharmacological knowledge.

• Modelling & Simulation (M&S):
  Execute fundamental M&S activities, including PKPD, Physiologically-Based Pharmacokinetics (PBPK), Drug-Drug Interaction (DDI), and human dose/regimen prediction, to provide essential support for projects spanning from Lead Optimisation (LO) through early and late-stage clinical development (EIH, Ph 2/3).

• Regulatory Mastery:
  Author and present definitive, high-quality scientific assessments of non-clinical DMPK data for critical internal program reviews and all major external regulatory submissions (IND, IB, CTA, NDA, BLA), ensuring global compliance and accelerated timelines.

• Implementation:
  Implement biomarker and bioanalytical strategies in close collaboration with key partners to ensure both patient safety and the achievement of meaningful therapeutic benefit.

• Cross-Functional Influence:
  Champion transparent, data-driven decision-making, acting as a trusted advisor and cultivating high-trust professional relationships across global project teams, governance…