DMPK-PD Project Leader

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. 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. 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). 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. Implement biomarker and bioanalytical strategies in close collaboration with key partners to ensure both patient safety and the achievement of meaningful therapeutic benefit. Champion transparent, data-driven decision-making, acting as a trusted advisor and cultivating high-trust professional relationships across global project teams, governance bodies, and external partnerships.

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.

• You hold a PharmD or PhD in Pharmaceutical Sciences, Pharmacology, Bioengineering or similar, coupled with over 5-10 years of industry experience in a pharmacokinetic-related role

• You possess deep, comprehensive expertise across the entire discovery preclinical and development spectrum, covering PK characterisation, distribution, and PKPD for diverse modalities (small molecules, biologics, nucleic acid-based therapeutics), grounded in authoritative knowledge of pharmacology and physiology.

• You demonstrate hands-on experience with modelling and simulation, proficiency in applying Artificial Intelligence (AI) and Machine Learning (ML) to DMPK strategy, and a strong drive to master tools like Phoenix, Berkeley Madonna, GastroPlus, or SimCyp.

• You combine an excellent understanding of PK/PD with strong communication skills and proven leadership experience to guide complex projects in a multi-disciplinary environment.

• You are accountable for defining and delivering clear outcomes, possessing the ability to transcend organisational boundaries to address or escalate issues effectively.

• You are an inclusive, authentic leader who actively seeks diversity and fosters a high-trust, high-performance environment where every team member is empowered to contribute their best.