Pharmacometrician_ Predictive Modeling & Data Analytics Chapter

at  Roche

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The Position
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.
That’s what makes us Roche.
In Roche’s Pharmaceutical Research and Early Development organization (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.
Within Roche’s Pharma Research and Early Development (pRED), Pharmaceutical Sciences (PS) is a pivotal function, comprising over 500 experts dedicated to ensuring the safety and efficacy of new drug candidates throughout the development lifecycle. PS plays a crucial role in developing safe and effective medicines by leveraging its expertise in translational safety, translational and clinical DMPK/PD, and biomarkers, guiding drug candidates from discovery to clinical proof of concept and filing.
The opportunity (including the key responsibilities)
As a pharmacometrician you contribute to developing medicines by designing and executing the pharmacometric strategy for programs in different stages of clinical development in one or more indication or disease areas. The pharmacometrics positions are located in the Predictive Modeling and Data Analytics chapter, where pharmacometrics is a primary focus area, together with other quantitative functions in Pharmaceutical Sciences. As a pharmacometrician you closely collaborate with other functions in pRED and/or development to ensure that the pharmacometric support is addressing the key needs to bring projects forward.

Key responsibilities

• Develop and execute scientifically sound, innovative and business-oriented Modeling & Simulation (M&S) strategic plans for projects in various disease areas and different stages of product development, including regulatory submissions.
• Develop and execute appropriate (population) pharmacokinetic and (population) pharmacodynamic models for the project and apply, if available for the project, empirical and/or mechanistically-based drug disease models as well as conduct simulations to inform drug development decisions such as dosage regimen selection and other trial design features.
• Communicate the outcome of M&S analysis to the project teams to support efficient discussion and decision making.
• Contribute to responses to health authority requests and interactions to align on Clinical development and M&S strategy, as well as interact on a scientific level with partners in project team(s) with regards to all aspects of the application of M&S to ensure efficient and appropriate integration of M&S strategy and results into internal and external project documents.

Who you are:

Essential

• PhD (pharmacology, pharmacometrics or natural sciences) with experience in planning and conducting M&S projects for clinical study data in a pharmaceutical industry setting.
• Strategic mindset and understanding of how and when M&S can contribute value in drug development and support decision making.
• Significant experience with M&S software (e.g. NONMEM, Monolix, R,…)

Desirable

• Previous experience of working on projects in neuroscience

In addition to your scientific expertise and critical technical skills we are looking for candidates who:

• are curious and have a growth mindset along with a keen willingness to foster the education of others on complex themes and technologies;
• bring excellent written communication and presentations skills with a high fluency in English;
• are resourceful and flexible in problem solving, and are able to work in agile matrix teams with a sense of urgency in a fair, open and collaborative manner

Your Location
This position is based in Basel
Our commitment
Roche commits to recognising talent and aptitude. We prioritise encouraging and supporting our employees on their personal journeys by providing a safe, creative space to help them reflect, make decisions and grow in their career.
We are confident that we find the most innovative solutions by gaining different perspectives, asking and answering hard questions, and challenging the status quo. Roche embraces diversity and equal opportunity in a serious yet enthusiastic way; we are devoted to building a team that represents a range of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more.
Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.
We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.

• Develop and execute scientifically sound, innovative and business-oriented Modeling & Simulation (M&S) strategic plans for projects in various disease areas and different stages of product development, including regulatory submissions.
• Develop and execute appropriate (population) pharmacokinetic and (population) pharmacodynamic models for the project and apply, if available for the project, empirical and/or mechanistically-based drug disease models as well as conduct simulations to inform drug development decisions such as dosage regimen selection and other trial design features.
• Communicate the outcome of M&S analysis to the project teams to support efficient discussion and decision making.
• Contribute to responses to health authority requests and interactions to align on Clinical development and M&S strategy, as well as interact on a scientific level with partners in project team(s) with regards to all aspects of the application of M&S to ensure efficient and appropriate integration of M&S strategy and results into internal and external project documents