Roche
Clinical Pharmacology Lead - Principal Scientist
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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 (pRED) organisation, we develop transformative medicines for patients to tackle some of the world’s biggest unmet healthcare needs. Our mission as pRED is to transform science into medicines, fostering a culture of curiosity, responsibility, and humility. We empower and inspire our talented teams to drive life-changing innovation at speed.
Our Pharmaceutical Sciences (PS) organisation bridges science and innovation to enable the discovery and development of safe, effective therapeutics at optimal doses for relevant populations. We achieve this by integrating three key pillars—Translational Safety, Translational Pharmacology, and Biomarkers—to drive asset development from target assessment to on-market support. Our goal: improve predictive accuracy, optimise dosing strategies, and accelerate the discovery of tomorrow’s safe and effective medicines.
Within the Clinical Pharmacology Section in the Quantitative Clinical Pharmacology Department, this role operates globally, embedded in cross-functional project teams and supports multiple focus disease areas, including CVRM, Immunology, Neuroscience, Oncology, and Ophthalmology.
The Opportunity
As the Quantitative and Clinical Pharmacology Lead, you will drive the scientific advancement of clinical drug programs by leading cross-functional projects and leveraging Model-Informed Drug Development (MIDD) to optimise trial designs, dose selections, and development decisions—across small/molecules, large/molecules, and novel platforms.
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Core Responsibilities
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Strategic & Quantitative Plan Execution
- Contribute to clinical development strategies, including clinical trial design, and lead the development and execution of Clinical Pharmacology and MIDD strategies.
- Apply Clinical Pharmacology principles to predictive models, guiding dose/regimen selection, drug-drug interactions (DDI), strategies for special populations, pediatric extrapolations, and geographic/ethnic bridging.
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Modelling & Simulation Mastery
- Apply pharmacometric methodologies (population PK/PD, PBPK, QSP) to enhance clinical trial simulation, characterise exposure-response relationships, and define quantitative criteria for go/no-go decisions.
- Proficiency required in pharmacometric tools (e.g., NONMEM, R, SimCyp, MATLAB).
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Regulatory & Asset Maximisation
- Lead Clinical Pharmacology sections of major regulatory documents (e.g., IB, IND, PIP, PSP, NDA, BLA), ensuring adherence to submission quality via lean development authoring and digital submission excellence.
- Act as a subject matter expert for internal/external health authority interactions.
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Business Development
- Provide clinic quantitative pharmacology expertise during due diligence for acquisition and divestment strategies.
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Digital Innovation
- Proactively integrate AI/ML methodologies into quantitative workflows to improve data interpretation and efficiency.
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Matrix Influence & Resilience
- Work effectively in a global, matrixed organisation, confidently addressing conflicts while fostering a challenger-safe environment for diverse perspectives.
- Support junior/mid-level colleagues through mentorship, strategic development, and skill enhancement.
Who You Are
You are a highly qualified Clinical Pharmacology and Quantitative Drug Development professional with:
- Education: A PhD, Pharm.D., or MD in Pharmacometrics, Clinical Pharmacology, or a closely related scientific discipline.
- Experience: At least 5+ years in the pharma/biotech sector, specialising in Quantitative Clinical Pharmacology. Proven success in applying MIDD principles.
- Technical Expertise:
- Strong grasp of clinical pharmacology, translational strategy, and PK/PD models.
- Proficient in core tools (NONMEM, R, or Simcyp) and data analytics, with an emerging focus on AI/ML.
- Skilled in aligning development programs with regulatory requirements and extracting evidence for strategic decision-making.
- Communication: Abundant leadership Presence: ability to distil complex quantitative findings into clear, actionable strategies for cross-functional teams.
- Matrix Influence & Resilience: Strategic thinker with flexibility in agile, unpredictable settings, ensuring project momentum even amidst global team dynamics.
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Why Join Roche?
At Roche, we strive for higher limits to deliver transformative healthcare solutions. Your work truly impacts patient lives and global healthcare systems—join us to make a meaningful difference.
Roche pioneers a healthier future. Over 100,000 employees globally are committed to advancing groundbreaking science, ensuring access to healthcare today and for generations to come. Our efforts already transform the lives of more than 26 million people through our medicines and 30 billion+ diagnostic tests.
Together, we foster creativity, curiosity, and ambition—paving the way for a healthier world.
Roche is an Equal Opportunity Employer. We welcome all and value diversity as our greatest strength.
렮학생 August locations: Basel details may be adjusted for remote/hybrid environments reflected during recruitment, though primary compensation remains tied to Basel (pay transparency guidelines apply). Additional locations covered later in hiring alignment.
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