DMPK-PD Project Leader

Reposted 19 Hours Ago
Be an Early Applicant
2 Locations
In-Office
Senior level
Healthtech • Biotech • Pharmaceutical
The Role
Lead DMPK-PD strategies and translational pharmacology across discovery and development. Provide PK/PD and PBPK modelling, DDI assessment, human dose/regimen prediction, author regulatory submissions, implement biomarker/bioanalytical strategies, and advise cross-functional project teams to enable clinical candidate selection and program progression.
Summary Generated by Built In

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 organisation (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 medicines. 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.

At the intersection of science and innovation, pRED’s Pharmaceutical Sciences (PS) organisation enables the 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. By seamlessly integrating our three core pillars—Translational Safety, Translational Pharmacology, and Biomarkers—we drive end-to-end asset development across the entire value chain, from target assessment to on-market support. Our mission is to continuously improve predictive accuracy, optimise dosing strategies for the right patient populations, and accelerate the development of tomorrow's safe and effective therapeutics.


The 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.
Your Impact & Responsibilities:

  • Strategy & Design: Define and lead drug design and optimisation strategies and compound profiling integrating cutting-edge Drug Metabolism and Pharmacokinetics (DMPK) principles, with a strong focus on target biology validation and translational PK/Pharmacodynamics (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.

  • Modelling & Simulation (M&S): Execute fundamental M&S activities, including PKPD, Physiologically-Based Pharmacokinetics (PBPK), Drug-Drug Interaction (DDI), and human dose/regimen prediction, to provide essential support for projects spanning from Lead Optimisation (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: Implement biomarker and bioanalytical strategies in close collaboration with key partners to ensure both patient safety and the achievement of meaningful 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 5-10 years of industry experience in a pharmacokinetic-related role

  • You possess deep, comprehensive expertise across the entire discovery preclinical and development spectrum, covering PK characterisation, distribution, and PKPD for diverse modalities (small molecules, biologics, nucleic acid-based therapeutics), grounded in authoritative knowledge of pharmacology and physiology.

  • You demonstrate hands-on experience with modelling and simulation, proficiency in applying Artificial Intelligence (AI) and Machine Learning (ML) to DMPK strategy, and a strong drive to master tools like Phoenix, Berkeley Madonna, GastroPlus, or SimCyp.

  • You combine an excellent understanding of PK/PD with strong communication skills and proven leadership experience to guide complex projects in a multi-disciplinary environment.

  • You are accountable for defining and delivering clear outcomes, possessing the ability to transcend organisational boundaries to address or escalate issues effectively.

  • You are an inclusive, authentic leader who actively seeks diversity and fosters a high-trust, high-performance environment where every team member is empowered to contribute their best.

At Roche, we aim high to deliver life-changing healthcare solutions. If you’re ready to make a meaningful impact on patients and healthcare systems worldwide, this is the place for you.

 

 

Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Basel. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.Who we are

A healthier future drives us to innovate. Together, more than 100’000 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.


Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.

Skills Required

  • PharmD or PhD in Pharmaceutical Sciences, Pharmacology, Bioengineering or similar
  • Over 5-10 years industry experience in a pharmacokinetic-related role
  • Deep expertise in PK characterisation, distribution, and PKPD across modalities (small molecules, biologics, nucleic acids)
  • Hands-on experience with modelling and simulation (PKPD, PBPK, DDI, human dose/regimen prediction)
  • Proficiency in or willingness to master tools such as Phoenix, Berkeley Madonna, GastroPlus, SimCyp
  • Experience applying AI/ML to DMPK strategy
  • Experience authoring scientific assessments for regulatory submissions (IND, IB, CTA, NDA, BLA)
  • Strong communication and proven leadership experience in multidisciplinary teams

Roche Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Roche and has not been reviewed or approved by Roche.

  • Retirement Support U.S. materials describe a 401(k) with both matching and an additional company contribution, supported by formal plan documents and true‑up features. This structure is positioned as a standout element of the total package, particularly at Genentech.
  • Leave & Time Off Breadth Time‑off provisions include substantial vacation, a year‑end shutdown, and a paid six‑week sabbatical after six years. These elements indicate a recharge‑oriented approach within the U.S. offering.
  • Healthcare Strength Company materials emphasize comprehensive medical, dental, vision, and mental‑health resources alongside well‑being programs. Benefits pages consistently highlight breadth across core health coverage elements.

Roche Insights

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The Company
Provincia de Buenos Aires
93,797 Employees
Year Founded: 1896

What We Do

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry ten years in a row by the Dow Jones Sustainability Indices (DJSI).

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