We are recruiting a DMPK-PD Project Leader to drive translational strategies and lead drug design teams in delivering safe, effective therapeutics. This role is ideal for experienced professionals in pharmaceutical sciences with a strong background in drug development.
Tasks
- Serve as the subject matter expert, guiding early discovery teams in developing translational strategies towards preclinical and clinical evaluation of target modulation, leveraging biochemical and pharmacological knowledge.
- Define and lead drug design teams towards required molecular properties; define comprehensive compound profiling strategies via application of cutting-edge DMPK principles with target biology validation and translational PK/PD concepts.
- Direct machine learning (ML and AI), modelling and simulation (M&S) activities (including PK/PD, 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 high-quality 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 robust 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 5 - 10 years of post-PhD industry experience in a pharmacokinetic-related role.
- Expertise across the entire discovery, preclinical and development spectrum, covering PK characterisation, distribution, and PKPD for various modalities (focus on biotherapeutics, antibody-drug conjugates, oligonucleotide therapeutics and novel formats), grounded in authoritative knowledge of pharmacology and physiology.
- Mastery of applied modelling and simulation platforms (e.g., Phoenix, Berkeley Madonna, GastroPlus, SimCyp).
- Practical experience or strong drive to apply Artificial Intelligence (AI) and Machine Learning (ML) methodologies to evolve DMPK strategies.
- Combine PK/PD understanding with outstanding communication, negotiation, and proven leadership experience, adept at guiding complex, multi-disciplinary projects.
- Fully accountable for defining strategic outcomes, ensuring expert delivery, and skillfully navigating and resolving critical issues across organisational and geographical boundaries.
- Inclusive, authentic matrix leader who champions diversity, mentors colleagues, and fosters a high-trust environment where every team member is empowered to contribute their best.
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Über uns
Das Team
At Roche’s Pharmaceutical Research and Early Development organization (pRED), teams are united by a mission to transform science into medicines, creating a culture defined by curiosity, responsibility, and humility. The Pharmaceutical Sciences (PS) organisation enables the discovery and development of safe and effective therapeutics at optimal doses in relevant populations, integrating Translational Safety, Translational Pharmacology, and Biomarkers to drive end-to-end asset development.