DMPK-PD Project Leader

About the role

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: 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 clinical development (EIH). Regulatory Mastery: Author and present definitive, high-quality scientific assessments of nonclinical 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.

Requirements

• You hold a PharmD or PhD in Pharmaceutical Sciences, Pharmacology, Bioengineering or similar, coupled with over 10 years of progressive industry experience in a senior pharmacokinetic-related role.
• 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 fosters a high-trust, high-performance environment where every team member is empowered to contribute their best.
• 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.
• If you are passionate about contributing to a committed team and have the dedication to partnership and innovation, Roche is the place for you!
• Every role at Roche pla

Benefits

Additional Information

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 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.

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