Clinical Pharmacology Lead - Principal Scientist

Roche Holding AG; Basel; Vor Ort; CHF 180.000 - 240.000; Vollzeit

Zusammenfassung

Roche, leader mondial de la biopharmacie, recherche un responsable CP clinique quantitative pour diriger les programmes cliniques et appliquer des approches MIDD afin d’optimiser les conceptions d’essais et les décisions de développement.

Le candidat idéal dispose d’un PhD/MD/PharmD en pharmacométrie, avec 5+ ans d’expérience dans l’industrie et une expertise en modélisation et logiciels avancés pour soutenir les décisions de développement.

Qualifikationen

• Docteur en pharmacie, médecin ou doctorat en pharmacométries/Pharmacologie Clinique.

Aufgaben

• Conduire les aspects de Pharmacologie Clinique (CP) à travers toutes les phases de développement, en tant que leader technique et scientifique.

Kenntnisse

NONMEM

R

SimCyp

MATLAB

pharmacometric software

Ausbildung

PhD, Pharm.D. ou MD en Pharmacologie Clinique ou pharmacométrie

Tools

R

NONMEM

SimCyp

MATLAB

Jobbeschreibung

Chez Roche, vous pouvez être vous-même et être apprécié pour les qualités uniques que vous apportez. Notre culture encourage l'expression personnelle, le dialogue ouvert et les connexions authentiques, où vous êtes valorisé, accepté et respecté pour ce que vous êtes, vous permettant de prospérer tant personnellement que professionnellement. Voici comment nous visons à prévenir, arrêter et guérir les maladies et à garantir à chacun l'accès aux soins de santé aujourd'hui et pour les générations à venir. Rejoignez Roche, où chaque voix compte.

La 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.

Qui nous sommes

Un avenir plus sain nous pousse à innover. Ensemble, plus de 100 000 employés à travers le monde sont dédiés à faire progresser la science et à garantir à chacun l'accès aux soins de santé aujourd'hui et pour les générations à venir. Nos efforts aboutissent à plus de 26 millions de personnes traitées avec nos médicaments et plus de 30 milliards de tests réalisés avec nos produits de Diagnostique. Nous nous encourageons mutuellement à explorer de nouvelles possibilités, à favoriser la créativité et à conserver nos grandes ambitions, afin de fournir des solutions de santé qui changent des vies et ont un impact mondial.

Construisons ensemble un avenir plus sain.

Roche est un employeur offrant l'équité en matière d'emploi.