DMPK-PD Project Leader

Chez Roche, vous pouvez être vous-même et être apprécié pour les qualités uniques que vous apportez. Notre culture encourage l'expression personnelle, le dialogue ouvert et les connexions authentiques, où vous êtes valorisé, accepté et respecté pour ce que vous êtes, vous permettant de prospérer tant personnellement que professionnellement. Voici comment nous visons à prévenir, arrêter et guérir les maladies et à garantir à chacun l'accès aux soins de santé aujourd'hui et pour les générations à venir. Rejoignez Roche, où chaque voix compte.

La position 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. The Opportunity 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 &

• 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 bodies, and external partnerships. Who You Are - 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. At Roche, we aim high to deliver life-changing healthcare solutions. If you’re ready to make a meaningful impact on patients and healthcare systems worldwide, this is the place for you. Qui nous sommes Un avenir plus sain nous pousse à innover. Ensemble, plus de 100 000 employés à travers le monde sont dédiés à faire progresser la science et à garantir à chacun l'accès aux soins de santé aujourd'hui et pour les générations à venir. Nos efforts aboutissent à plus de 26 millions de personnes traitées avec nos médicaments et plus de 30 milliards de tests réalisés avec nos produits de Diagnostique. Nous nous encourageons mutuellement à explorer de nouvelles possibilités, à favoriser la créativité et à conserver nos grandes ambitions, afin de fournir des solutions de santé qui changent des vies et ont un impact mondial. Construisons ensemble un avenir plus sain. Roche est un employeur offrant l'équité en matière d'emploi.