DMPK-PD Project Leader

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position In Roche’s Pharmaceutical Research and Early Development organization (pRED), we make transformative medicines for patients in order 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 Department, 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, collaborate across therapeutic areas to transform scientific hypotheses into clinical ready drug candidates. Your Impact & Responsibilities: Translational Expertise: Serve as the subject matter expert, guiding early discovery teams in developing translational strategies towards preclinical and clinical evaluation of target modulation, leveraging biochemical and pharmacological knowledge. Strategic Leadership: Define and lead drug design teams towards required molecular properties; define comprehensive compound profiling strategies via application of cutting-edge DMPK principles with target biology validation and translational PK/PD concepts. Applies Modelling & Simulation (M&S): Direct machine learning (ML and AI), M&S activities (including PK/PD, PBPK, DDI, and human dose/regimen prediction) to critically inform and de-risk projects 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 & Innovation: Pioneer and oversee the implementation of robust biomarker and bioanalytical strategies in close partnership with key stakeholders to maximise patient safety and 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 post-PhD industry experience in a pharmacokinetic-related role. You possess expertise across the entire discovery, preclinical and development spectrum, covering PK characterisation, distribution, and PKPD for ideally various modalities (focus on biotherapeutics, antibody-drug conjugates, oligonucleotide therapeutics and novel formats), grounded in authoritative knowledge of pharmacology and physiology evidenced by industry experience and contributions to candidate phase transitions. You demonstrate mastery of applied modelling and simulation platforms (e.g., Phoenix, Berkeley Madonna, GastroPlus, SimCyp) and possess practical experience or a strong drive to apply Artificial Intelligence (AI) and Machine Learning (ML) methodologies to evolve DMPK strategies. You combine PK/PD understanding with outstanding communication, negotiation, and proven leadership experience, adept at guiding complex, multi-disciplinary projects. You are fully accountable for defining strategic outcomes, ensuring expert delivery, and skillfully navigating and resolving critical issues across organisational and geographical boundaries. You are an inclusive, authentic matrix leader who champions diversity, mentors colleagues, and actively fosters a high-trust 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. Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.