DMPK-PD Project Leader
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Job Location:
Basel - Switzerland
Monthly Salary:
Not Disclosed
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
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
pREDs 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 tomorrows medicines. PS supports discovery and development across the whole value chain from target assessment to on-market and beyond.
The Opportunity
As an experienced DMPK-PD Project Leader within the Translational DMPK-PD and Clinical Pharmacology chapter 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 optimization 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 Modeling & 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 Optimization (LO) through early and late-stage clinical development (EIH Ph 2/3).
Regulatory Mastery: Author and present definitive high-quality scientific assessments of non-clinical 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 maximize 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.
Who You Are
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 possess deep comprehensive expertise across the entire discovery preclinical and development spectrum covering PK characterization distribution and PKPD for diverse modalities (small molecules biologics novel therapeutics) grounded in authoritative knowledge of pharmacology and physiology.
You demonstrate mastery of advanced modeling 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 organizational 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 plays a part in making a difference in patients lives. Apply now and join us in making an impact!
Who we are
A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Required Experience:
Senior IC
Key Skills
About Company
F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel.
