At a Glance
- Tasks: Lead clinical pharmacology programs and optimise drug development strategies.
- Company: Join Roche, a leader in transformative medicines and innovative healthcare solutions.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Collaborative environment with mentorship opportunities and a focus on digital innovation.
- Why this job: Make a real impact on global health by advancing life-changing therapies.
- Qualifications: PhD, Pharm.D., or MD with 5+ years in Quantitative Clinical Pharmacology.
The Position
In Roche’s Pharmaceutical Research and Early Development organisation (pRED), we make transformative medicines for patients in order 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.
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.
Within the Clinical Pharmacology Section in the Quantitative Clinical Pharmacology Department, this position operates globally, is deeply embedded within cross‑functional matrix project teams and can support multiple of Roche’s focus disease areas (CVRM, Immunology, Neuroscience, Oncology and Ophthalmology).
The Opportunity
In this role, you will lead the scientific advancement of clinical programs by serving as the core quantitative and clinical pharmacology lead within cross‑functional project teams. You will drive all aspects of Clinical Pharmacology (CP) across all development phases and strategically apply Model‑Informed Drug Development (MIDD) approaches to optimise trial designs, justify dose selections, inform development decisions and mitigate risks across both early and late‑stage development. Your scope will be modality‑agnostic, giving you oversight that spans small molecules, large molecules, and novel platforms.
- Strategic & Quantitative Plan Execution: Actively contribute to the development of clinical development strategies, including the design of clinical trials and lead the development, implementation, and execution of the Clinical Pharmacology and MIDD strategies for assigned assets across all development phases. Translate Clinical Pharmacology principles into predictive models that guide dose/regimen selection, drug‑drug interactions (DDI), special population strategies, pediatric extrapolations and geographic/ethnic bridging.
- Modelling & Simulation Mastery: Apply pharmacometric methodologies (such as population PK/PD, PBPK, or QSP) to perform clinical trial simulations, characterise exposure‑response relationships, and define quantitative criteria for early, data‑driven go/no‑go decisions. Proficiency in pharmacometric software (e.g., NONMEM, R, SimCyp, MATLAB) is required.
- Regulatory & Asset Maximisation: Lead the CP sections of major regulatory documents (including IB, IND, PIP, PSP, NDA, BLA). Ensure high‑quality, fit‑for‑purpose submission documents using Roche initiatives like lean development authoring and digital submission excellence. Represent the company as a subject matter expert in health authority interactions.
- Business Development: Provide clinical and quantitative pharmacology expertise during due diligence for in‑licensing and out‑licensing activities.
- Digital Innovation: Proactively develop and incorporate AI/ML methodologies into Clinical Pharmacology activities and day‑to‑day quantitative workflows to optimise data interpretation and efficiency.
- Matrix Influence & Resilience: Work effectively across a complex, global matrix organisation. Address conflicts with high resilience and foster an environment of challenger safety where diverse scientific views are valued.
- Mentorship: Guide and mentor junior scientists within the department to foster strategic and technical growth and professional development.
Who You Are
- Education: You hold a PhD, Pharm.D., or MD with a specialisation in Pharmacometrics, Clinical Pharmacology, or a related scientific discipline.
- Experience: You bring 5+ years of experience in the pharmaceutical or biotech industry in the area of Quantitative Clinical Pharmacology. You have a strong understanding of drug discovery and clinical development, including biology and disease knowledge, and you bring a proven track record of applying Model‑Informed Drug Development (MIDD) principles.
- Technical Toolkit: You have a strong foundation in Clinical Pharmacology principles and quantitative drug development, with a solid understanding and experience in applying advanced quantitative modelling (proven proficiency in core pharmacometric software/tool kits such as NONMEM, R or Simcyp), data analytics, and emerging AI‑enabled approaches to support evidence‑based decision‑making. You understand the regulatory landscape and how to integrate diverse data to optimise development.
- Communication: You have outstanding communication skills and a clear ability to translate complex quantitative data into actionable strategic messages for cross‑functional leadership.
- Matrix Influence & Resilience: You demonstrate strategic thinking, matrix flexibility and high resilience, working effectively across global organisations to handle conflicts and foster an environment of challenger safety where diverse scientific views are valued.
Roche is an Equal Opportunity Employer.
Clinical Pharmacology Lead - Principal Scientist in Welwyn employer: Roche
Roche is an exceptional employer, offering a dynamic work environment in the heart of pharmaceutical innovation. With a strong commitment to employee growth, we provide opportunities for mentorship and professional development, fostering a culture of curiosity and collaboration. Our location enables access to cutting-edge resources and a diverse team, empowering you to make a meaningful impact on global healthcare challenges.
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We think this is how you could land Clinical Pharmacology Lead - Principal Scientist in Welwyn
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We think you need these skills to ace Clinical Pharmacology Lead - Principal Scientist in Welwyn
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Roche!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Roche that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Roche!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Roche, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Roche
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Roche that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Roche’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
