We are looking for an experienced DMPK-PD Project Leader to drive drug design and optimisation strategies within Roche’s Translational DMPK-PD Group. Lead nonclinical and translational initiatives, collaborate across therapeutic areas, and apply advanced pharmacokinetics expertise. Ideal for candidates with significant industry experience in pharmacokinetics and a strong background in pharmaceutical sciences.
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.
Tasks
- Define and lead drug design and optimisation strategies and compound profiling, integrating Drug Metabolism and Pharmacokinetics (DMPK) principles with a focus on target biology validation and translational PK/Pharmacodynamics (PD) concepts.
- Serve as the subject matter expert, guiding early discovery teams in developing translational strategies for clinical evaluation of target modulation, leveraging biochemical and pharmacological knowledge.
- Execute modelling and simulation activities, including PKPD, Physiologically-Based Pharmacokinetics (PBPK), Drug-Drug Interaction (DDI), and human dose/regimen prediction, supporting projects from Lead Optimisation through early and late-stage clinical development.
- Author and present scientific assessments of non-clinical DMPK data for internal program reviews and external regulatory submissions (IND, IB, CTA, NDA, BLA), ensuring global compliance and accelerated timelines.
- Implement biomarker and bioanalytical strategies in collaboration with key partners to ensure patient safety and therapeutic benefit.
- 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.
Requirements
- PharmD or PhD in Pharmaceutical Sciences, Pharmacology, Bioengineering or similar, with over 5-10 years of industry experience in a pharmacokinetic-related role.
- Deep expertise across the discovery preclinical and development spectrum, including PK characterisation, distribution, and PKPD for diverse modalities (small molecules, biologics, nucleic acid-based therapeutics), grounded in pharmacology and physiology knowledge.
- Hands-on experience with modelling and simulation, proficiency in applying Artificial Intelligence (AI) and Machine Learning (ML) to DMPK strategy, and a drive to master tools such as Phoenix, Berkeley Madonna, GastroPlus, or SimCyp.
- Excellent understanding of PK/PD, strong communication skills, and proven leadership experience to guide complex projects in a multi-disciplinary environment.
- Accountable for defining and delivering clear outcomes, with the ability to transcend organisational boundaries to address or escalate issues effectively.
- Inclusive, authentic leadership style, actively seeking diversity and fostering a high-trust, high-performance environment where every team member is empowered to contribute their best.
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Das Team
Within Roche’s Pharmaceutical Research and Early Development organisation (pRED), the Pharmaceutical Sciences (PS) organisation enables the discovery and development of safe and effective therapeutics at optimal doses. The team integrates Translational Safety, Translational Pharmacology, and Biomarkers to drive asset development across the value chain, fostering a culture defined by curiosity, responsibility, and humility.