Take on a pivotal role driving advanced drug design and translational strategies within Roche’s Pharmaceutical Research and Early Development. This opportunity is ideal for an experienced pharmacokinetic leader with deep expertise in drug design and complex modelling, contributing to transformative medicines for patients and tackling some of the world’s toughest unmet healthcare needs.
Tasks
- Define and lead advanced drug design, optimisation strategies, and comprehensive compound profiling, integrating DMPK principles with target biology validation and complex translational PK/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.
- Direct advanced modelling and simulation activities (including complex PKPD, PBPK, DDI, and human dose/regimen prediction) to inform and de-risk 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 major external regulatory submissions (IND, IB, CTA, NDA, BLA), ensuring global compliance and accelerated timelines.
- Pioneer and oversee the implementation of biomarker and bioanalytical strategies in partnership with key stakeholders to maximise 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
- Hold a PharmD or PhD in Pharmaceutical Sciences, Pharmacology, Bioengineering or similar, with over 15 - 20 years of post-PhD progressive industry experience in a senior pharmacokinetic-related role.
- Possess deep expertise across the 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.
- Demonstrate mastery of advanced modelling and simulation platforms (e.g., Phoenix, Berkeley Madonna, GastroPlus, SimCyp).
- Have practical experience or a strong drive to apply Artificial Intelligence (AI) and Machine Learning (ML) methodologies to evolve DMPK strategies.
- Combine exceptional PK/PD understanding with outstanding communication, negotiation, and proven senior leadership experience, adept at guiding highly complex, multi-disciplinary projects.
- Be fully accountable for defining strategic outcomes, ensuring expert delivery, and skillfully navigating and resolving critical issues across organisational and geographical boundaries.
- Be an inclusive, authentic leader who champions diversity, mentors colleagues, and fosters a high-trust, high-performance environment where every team member is empowered to contribute their best.
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Über uns
Das Team
At pRED’s Pharmaceutical Sciences organisation, teams enable the discovery and development of safe and effective therapeutics at optimal doses in relevant populations. The department integrates Translational Safety, Translational Pharmacology, and Biomarkers to drive asset development across the value chain, fostering a culture defined by curiosity, responsibility, and humility.