Clinical Pharmacology Lead - Principal Scientist

Lead the scientific advancement of clinical programs as the core quantitative and clinical pharmacology lead within cross-functional project teams. Drive all aspects of Clinical Pharmacology (CP) across development phases and apply Model-Informed Drug Development (MIDD) approaches to optimise trial designs, justify dose selections, inform development decisions and mitigate risks across early and late-stage development. Work across small molecules, large molecules, and novel platforms.

Strategic & Quantitative Plan Execution: Contribute to clinical development strategies, including clinical trial design, and lead the development, implementation, and execution of 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.

Regulatory & Asset Maximisation: Lead the CP sections of major regulatory documents, including IB, IND, PIP, PSP, NDA, and 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: 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.

Roche’s Pharmaceutical Research and Early Development organisation (pRED) makes transformative medicines for patients to tackle unmet healthcare needs. Its mission is to transform science into medicines, with a culture defined by curiosity, responsibility, and humility.

pRED’s Pharmaceutical Sciences (PS) organisation enables the discovery and development of safe and effective therapeutics at optimal doses in relevant populations. Its three core pillars are Translational Safety, Translational Pharmacology, and Biomarkers, working across the value chain from target assessment to on-market support.

The position is within the Clinical Pharmacology Section in the Quantitative Clinical Pharmacology Department. It operates globally, is embedded within cross-functional matrix project teams, and can support Roche focus disease areas including CVRM, Immunology, Neuroscience, Oncology and Ophthalmology.

• PhD, Pharm.D., or MD with a specialisation in Pharmacometrics, Clinical Pharmacology, or a related scientific discipline.

• 5+ years of experience in the pharmaceutical or biotech industry in Quantitative Clinical Pharmacology.

• Strong understanding of drug discovery and clinical development, including biology and disease knowledge, and a proven track record of applying Model-Informed Drug Development (MIDD) principles.

• Strong foundation in Clinical Pharmacology principles and quantitative drug development, with experience applying advanced quantitative modelling and proficiency in pharmacometric software/tool kits such as NONMEM, R or Simcyp.

• Experience in data analytics and emerging AI-enabled approaches to support evidence-based decision-making.

• Understanding of the regulatory landscape and how to integrate diverse data to optimise development.

• Outstanding communication skills and ability to translate complex quantitative data into actionable strategic messages for cross-functional leadership.

• Strategic thinking, matrix flexibility and high resilience; ability to work effectively across global organisations, handle conflicts and foster an environment of challenger safety where diverse scientific views are valued.