Clinical Pharmacology Lead - Principal Scientist

Clinical Pharmacology Lead - Principal Scientist

Roche

Basel or Welwyn

The Position

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, SimCyp, 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 expertise during due diligence for in-licensing and out-licensing activities.
• Digital Innovation: Proactively develop and incorporate AI/ML methodologies into Clinical Pharmacology activities and day-to-day quantitative workflows to optimise data interpretation and efficiency.
• Matrix Influence & Resilience: Work effectively across a complex, global matrix organisation. Address conflicts with high resilience and foster an environment of challenger safety where diverse scientific views are valued.
• Mentorship: Guide and mentor junior scientists within the department to foster strategic and technical growth and professional development.

Who You Are

• Education: You hold a PhD, Pharm.D., or MD with a specialisation in Pharmacometrics, Clinical Pharmacology, or a related scientific discipline.
• Experience: You bring 5+ years of experience in the pharmaceutical or biotech industry in the area of Quantitative Clinical Pharmacology. You have a strong understanding of drug discovery and clinical development, including biology and disease knowledge, and you bring a proven track record of applying Model-Informed Drug Development (MIDD) principles.
• Technical Toolkit: You have a strong foundation in Clinical Pharmacology principles and quantitative drug development, with a solid understanding and experience in applying advanced quantitative modelling (proven proficiency in core pharmacometric software/tool kits such as NONMEM, R or Simcyp), data analytics, and emerging AI-enabled approaches to support evidence-based decision-making. You understand the regulatory landscape and how to integrate diverse data to optimise development.
• Communication: You have outstanding communication skills and a clear ability to translate complex quantitative data into actionable strategic messages for cross-functional leadership.
• Matrix Influence & Resilience: You demonstrate strategic thinking, matrix flexibility and high resilience, working effectively across global organisations to handle conflicts and foster an environment of challenger safety where diverse scientific views are valued.