Senior DMPK-PD Project Leader

Roche; Penzberg; Vor Ort; EUR 193.000 - 257.000; Vollzeit

Zusammenfassung

Roche seeks a seasoned DMPK-PD Project Leader to drive nonclinical and translational strategies, ensuring safe and efficacious drug delivery at the right dose. You will lead multidisciplinary teams across discovery, preclinical, and development, shaping PK/PD data and regulatory interactions.

You will leverage expertise in PK/PD, modelling platforms, and AI/ML to advance projects from Lead Optimisation through late-stage clinical development, while mentoring colleagues and fostering

Qualifikationen

• PharmD or PhD in Pharmaceutical Sciences, Pharmacology, Bioengineering or similar.
• 15–20 years of post-PhD progressive industry experience in a senior pharmacokinetic-related role.
• Experience with PK/PD modelling and translational strategies.
• Strong leadership and cross-functional collaboration.

Aufgaben

• Define and lead advanced drug design, optimisation strategies, and comprehensive compound profiling with DMPK principles.
• Guide early discovery teams in translational strategies for clinical evaluation of target modulation.
• Direct advanced modelling and simulation activities to inform and de-risk projects from LO to Ph2/3.
• Author and present non-clinical DMPK assessments for internal reviews and regulatory submissions.
• Pioneer biomarker and bioanalytical strategies in partnership with stakeholders.
• Champion data-driven decision-making across global project teams and external partners.

Kenntnisse

PK/PD modelling

Pharmacokinetics

Leadership

Cross-functional

Communication

AI/ML in DMPK

Ausbildung

PharmD or PhD in Pharmaceutical Sciences/Pharmacology/Bioengineering

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 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.

The Opportunity

As an experienced DMPK-PD Project Leader within the Translational DMPK-PD Department, 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:

• Strategic Leadership: Define and lead advanced drug design, optimisation strategies, and comprehensive compound profiling, integrating cutting-edge DMPK principles with target biology validation and complex translational PK/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
• Advanced Modelling & Simulation (M&S): Direct advanced M&S activities (including complex PKPD, PBPK, DDI, and sophisticated human dose/regimen prediction) to critically inform and de-risk projects 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 & Innovation: Pioneer and oversee the implementation of robust biomarker and bioanalytical strategies in close partnership with key stakeholders to maximise patient safety and 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 15 - 20 years of post-PhD progressive industry experience in a senior 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, novel therapeutics), grounded in authoritative knowledge of pharmacology and physiology
• You demonstrate mastery of advanced modelling and simulation platforms (e.g., Phoenix, Berkeley Madonna, GastroPlus, SimCyp) and possess practical experience or a strong drive to apply Artificial Intelligence (AI) and Machine Learning (ML) methodologies to evolve DMPK strategies
• You combine exceptional PK/PD understanding with outstanding communication, negotiation, and proven senior leadership experience, adept at guiding highly complex, multi-disciplinary projects
• You are fully accountable for defining strategic outcomes, ensuring expert delivery, and skillfully navigating and resolving critical issues across organisational and geographical boundaries
• You are an inclusive, authentic leader who champions diversity, mentors colleagues, and actively foster

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.