DMPK-PD Project Leader (2-year temporary position)

In Roche’s Pharmaceutical Research and Early Development organization (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 medicine. 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.

pRED’s Pharmaceutical Sciences (PS) group enables 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. PS supports discovery and development across the whole value chain from target assessment to on-market and beyond.

As part of the Translational DMPK-PD and Clinical Pharmacology chapter, you will focus on providing the right drug at the right dose to patients safely with an efficacious benefit. You will collaborate closely with therapeutic areas to convert hypotheses into innovative medicines, driving nonclinical strategies to bring forward the best clinical candidates for specific indications.

Your Impact & Responsibilities:

• Strategy & Design: Lead drug design and optimization strategies and compound profiling for all Drug Metabolism and Pharmacokinetics (DMPK) aspects, with a strong focus on target biology validation and translational PK/Pharmacodynamics (PD) concepts.
• Translational Evaluation: Provide support to early discovery teams in the development of translational strategies for the clinical evaluation of target modulation through the application of biochemical and pharmacological considerations.
• Modeling & 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 Optimization (LO) through Entry into Human (EIH).
• Regulatory Support: Prepare and deliver high-quality scientific assessments of non-clinical DMPK information for internal program reviews and external regulatory submissions (e.g., Investigational New Drug (IND), Investigator's Brochure (IB), Clinical Trial Application (CTA), New Drug Application (NDA), Biologics License Application (BLA)).
• Implementation: Implement biomarker and bioanalytical strategies in close collaboration with key partners to ensure both patient safety and the achievement of meaningful therapeutic benefit.
• Collaboration: Facilitate transparent, data-driven decision-making processes within project teams and squads while cultivating and maintaining trustful professional relationships with both internal and external stakeholders.

Bitte beachten Sie, dass diese Position ein 2-jähriger befristeter Vertrag ist.

Who you are:

• You hold a PharmD or PhD in Pharmaceutical Sciences, Pharmacology, or Bioengineering, paired with over 5 years of industry experience in a pharmacokinetic-related field.
• You possess deep expertise in discovery, early PK characterization, distribution, and PKPD across various modalities, backed by a solid foundation in pharmacology and physiology.
• You demonstrate hands-on experience with modeling and simulation, proficiency in applying Artificial Intelligence (AI) 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.
• You are accountable for defining and delivering clear outcomes, possessing the ability to transcend organizational boundaries to address or escape issues effectively.
• You are an inclusive, authentic leader who actively seeks diversity and fosters a high-trust environment where every team member can fully contribute.

Unwavering focus, collaborative teamwork and exceptional delivery are key behaviours that drive our mission of doing now what patients need next. Together, we can be transformative.

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