We are seeking a Clinical Pharmacology Lead - Principal Scientist to drive scientific advancement in clinical programmes, leading quantitative and clinical pharmacology initiatives. You will apply advanced pharmacometric modelling and model-informed drug development strategies, supporting multiple disease areas.
At Roche, you are 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.
Tasks
- Lead scientific advancement of clinical programs as the core quantitative and clinical pharmacology lead within cross-functional project teams.
- Drive all aspects of Clinical Pharmacology 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.
- Actively contribute to the development of clinical development strategies, including the design of clinical trials, 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.
- 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.
- Lead the Clinical Pharmacology sections of major regulatory documents (including IB, IND, PIP, PSP, NDA, BLA) and 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.
- Provide clinical and quantitative pharmacology expertise during due diligence for in-licensing and out-licensing activities.
- Proactively develop and incorporate AI/ML methodologies into Clinical Pharmacology activities and day-to-day quantitative workflows to optimise data interpretation and efficiency.
- 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.
- Guide and mentor junior scientists within the department to foster strategic and technical growth and professional development.
Requirements
- 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 the area of Quantitative Clinical Pharmacology.
- Strong understanding of drug discovery and clinical development, including biology and disease knowledge.
- Proven track record of applying Model-Informed Drug Development (MIDD) principles.
- Strong foundation in Clinical Pharmacology principles and quantitative drug development.
- Solid understanding and experience in applying advanced quantitative modelling.
- Proven proficiency in core pharmacometric software/tool kits such as NONMEM, R or Simcyp.
- Experience with data analytics and emerging AI-enabled approaches to support evidence-based decision-making.
- Understanding of the regulatory landscape and ability 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, working effectively across global organisations to handle conflicts and foster an environment of challenger safety where diverse scientific views are valued.
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Über uns
Das Team
This position operates globally within Roche’s Pharmaceutical Research and Early Development organisation (pRED), embedded in cross-functional matrix project teams and supporting multiple disease areas including CVRM, Immunology, Neuroscience, Oncology and Ophthalmology. The team is empowered and inspired to bring forward extraordinary, life-changing innovation at speed, fostering a culture defined by curiosity, responsibility, and humility.