DMPK-PD Project Leader

Roche; Basel; Vor Ort; CHF 150.000 - 190.000; Vollzeit

Zusammenfassung

Roche seeks an experienced DMPK-PD Project Leader within pRED to drive translational strategies ensuring correct dosing for patients. You will lead nonclinical and translational efforts, guiding projects from target validation to clinical readiness.

You will apply PK/PD, modelling, and PBPK approaches, collaborating across functions to shape regulatory submissions and clinical strategy for successful advancement.

Qualifikationen

• PharmD or PhD in Pharmaceutical Sciences, Pharmacology, Bioengineering or similar required.
• 5–10 years of industry experience in a pharmacokinetic-related role.
• Deep PK/PD expertise across discovery preclinical and development stages.

Aufgaben

• Define and lead drug design and optimisation strategies with DMPK integration.
• Guide early discovery teams with translational strategies for clinical evaluation of target modulation.
• Execute PK/PD modelling, PBPK, DDI, and dose prediction to support LO through Ph2/3.
• Author and present non-clinical DMPK data for internal reviews and regulatory submissions.
• Implement biomarker and bioanalytical strategies with partners to ensure patient safety and efficacy.
• Champion data-driven decision making across global teams and external partnerships.

Kenntnisse

Modelling & Simulation

PK/PD

AI/ML for DMPK

Leadership

Cross-functional collaboration

Ausbildung

PharmD or PhD in Pharmaceutical Sciences, Pharmacology, Bioengineering or similar

Tools

Phoenix

Berkeley Madonna

GastroPlus

SimCyp

Jobbeschreibung

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 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.

The Opportunity

As an experienced DMPK-PD Project Leader within the Translational DMPK-PD Group, you will be pivotal in ensuring the right drug is delivered at the right dose, safely and efficaciously, to patients. You will lead nonclinical and translational strategies, collaborating across therapeutic areas to transform scientific hypotheses into groundbreaking clinical candidates.

Your Impact & Responsibilities:

• Strategy & Design: Define and lead drug design and optimisation strategies and compound profiling integrating cutting‑edge Drug Metabolism and Pharmacokinetics (DMPK) principles, with a strong focus on target biology validation and translational PK/Pharmacodynamics (PD) concepts
• Translational Expertise: Serve as the subject matter expert, guiding early discovery teams in developing sophisticated translational strategies for clinical evaluation of target modulation, leveraging deep biochemical and pharmacological knowledge
• Modelling & Simulation (M&S): Execute fundamental M&S activities, including PKPD, Physiologically‑Based Pharmacokinetics (PBPK), Drug‑Drug Interaction (DDI), and human dose/regimen prediction, to provide essential support for projects spanning from Lead Optimisation (LO) through early and late‑stage clinical development (EIH, Ph 2/3)
• Regulatory Mastery: Author and present definitive, high‑quality scientific assessments of non‑clinical DMPK data for critical internal program reviews and all major external regulatory submissions (IND, IB, CTA, NDA, BLA), ensuring global compliance and accelerated timelines
• Implementation: Implement biomarker and bioanalytical strategies in close collaboration with key partners to ensure both patient safety and the achievement of meaningful therapeutic benefit
• Cross‑Functional Influence: Champion transparent, data‑driven decision‑making, acting as a trusted advisor and cultivating high‑trust professional relationships across global project teams, governance bodies, and external partnerships

Who You Are

• You hold a PharmD or PhD in Pharmaceutical Sciences, Pharmacology, Bioengineering or similar, coupled with over 5-10 years of industry experience in a pharmacokinetic-related role
• You possess deep, comprehensive expertise across the entire discovery preclinical and development spectrum, covering PK characterisation, distribution, and PKPD for diverse modalities (small molecules, biologics, nucleic acid-based therapeutics), grounded in authoritative knowledge of pharmacology and physiology
• You demonstrate hands‑on experience with modelling and simulation, proficiency in applying Artificial Intelligence (AI) and Machine Learning (ML) to DMPK strategy, and a strong drive to master tools like Phoenix, Berkeley Madonna, GastroPlus, or SimCyp
• You combine an excellent understanding of PK/PD with strong communication skills and proven leadership experience to guide complex projects in a multi‑disciplinary environment
• You are accountable for defining and delivering clear outcomes, possessing the ability to transcend organisational boundaries to address or elevate issues effectively
• You are an inclusive, authentic leader who actively seeks diversity and fosters a high‑trust, high‑performance environment where every team member is empowered to contribute their best

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.

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.