DMPK-PD Project Leader

Opportunity:
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.

• 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 & {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.

• You hold a Pharm
  
  D 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 possess deep, comprehensive expertise across the entire discovery, nonclinical 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.
• You demonstrate mastery of advanced modelling and simulation platforms (e.g., Phoenix, Berkeley Madonna, Gastro Plus, Sim Cyp) 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.

Roche is an Equal Opportunity Employer.