Clinical Pharmacology Lead - Principal Scientist

## Clinical Pharmacology Lead - Principal Scientist Candidatar-selocations:
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In Roche’s Pharmaceutical Research and Early Development organisation (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  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. Within the Clinical Pharmacology Section in the Quantitative Clinical Pharmacology Department, this position operates globally, is deeply embedded within cross-functional matrix project teams and can support multiple of Roche's focus disease areas (CVRM, Immunology, Neuroscience, Oncology and Ophthalmology).###

The Opportunity In this role, you will lead the scientific advancement of clinical programs by serving as the core quantitative and clinical pharmacology lead within cross-functional project teams. You will drive all aspects of Clinical Pharmacology (CP) across all development phases and strategically apply Model-Informed Drug Development (MIDD) approaches to optimise trial designs, justify dose selections, inform development decisions and mitigate risks across both early and late-stage development.

Your scope will be modality-agnostic, giving you oversight that spans small molecules, large molecules, and novel platforms.
* Strategic & Quantitative Plan Execution:
Actively contribute to the development of clinical development strategies, including the design of clinical trials and lead the development, implementation, and execution of the Clinical Pharmacology and MIDD strategies for assigned assets across all development phases. Translate Clinical Pharmacology principles into predictive models that guide dose/regimen selection, drug-drug interactions (DDI), special population strategies, pediatric extrapolations and geographic/ethnic bridging.
* Modelling & Simulation Mastery:
Apply pharmacometric methodologies (such as population PK/PD, PBPK, or QSP) to perform clinical trial simulations, characterise exposure-response relationships, and define quantitative criteria for early, data-driven go/no-go decisions. You bring proficiency in pharmacometric software (e.g., NONMEM, R, Sim Cyp, MATLAB).
* Regulatory & Asset Maximisation:
Lead the CP sections of major regulatory documents (including IB, IND, PIP, PSP, NDA, BLA). Ensure high-quality, fit-for-purpose submission documents using Roche initiatives like lean development authoring and digital submission excellence. Represent the company as a subject matter expert in health authority interactions.
* Business Development:
Provide clinical and quantitative pharmacology…