Clinical Pharmacology Lead - Principal Scientist

Roche; Welwyn; On-site; GBP 164,000 - 218,000; Full time

Job summary

Roche is seeking a senior Clinical Pharmacology expert to lead quantitative pharmacology efforts across early and late development. You will apply Model-Informed Drug Development to optimise trial designs, dose selections, and risk mitigation, spanning small and large molecules and novel platforms.

You will influence cross-functional teams, advance predictive modeling, and mentor junior scientists while contributing to regulatory submissions and strategic planning.

Qualifications

• Pharmaceutical/biotech PhD/MD/PharmD with relevant specialization.
• 5+ years of experience in Quantitative Clinical Pharmacology.
• Strong modeling and data analytics capability.

Responsibilities

• Lead CP and MIDD strategies across development phases.
• Develop predictive models for dose/regimen selection and DDI.
• Prepare regulatory documents and liaise with health authorities.

Skills

Pharmacometrics

Clinical pharmacology

MIDD methods

NONMEM

R

SimCyp

AI/ML in pharma

Education

PhD/PharmD/MD

Tools

SimCyp

R

MATLAB

Job description

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 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 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.

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.

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.

Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Basel. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.

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.