PhD position in Pharmacometrics for regulatory science

The Department of Pharmacy (IFF) at Uppsala University has an interdisciplinary environment at the center of the pharmaceutical arena. With frontline research, first-rate education and extensive collaborations we constitute an important driving force in the development of our academic field. IFF has approximately 150 employees and a revenue of nearly 180 million SEK. In this inspiring environment our rich diversity of research groups, several of international prominence, develop and conduct work of great scientific importance. Among our core competences are computational modelling and simulations, PKPD, in vitro ADME models, advanced in vivo methods, development of biological medicines, as well as patient and societal aspects, from optimizing the use of drugs in individuals to societal pharmaceutical policies. Together, we form a unique cluster of academic competences within pharmaceutical science, playing a key role in shaping the future of pharmacy in both Sweden and globally.

Our scientific focus areas in selection: • Biologics • Clinical Pharmacy • Drug Delivery • Molecular Pharmaceutics • Pharmaceutics and Nanotechnology• Pharmacometrics • Pharmacodynamics • Pharmacokinetics • Pharmacoeconomics • Pharmacoepidemiology • Pharmacotherapy • Social Pharmacy

More information www.farmaci.uu.se

Research School in Regulatory Science:

This PhD position is affiliated with the Research School in Regulatory Science, a new initiative at the Faculty of Pharmacy. Regulatory science can be defined as the science of developing and applying new tools, standards, and methods to assess the safety, efficacy, quality, and performance of products regulated by national or international authorities. The research school aims to establish and strengthen the faculty's role as a leading center of excellence by training PhDs with integrated research and regulatory competence through strategic collaborations with authorities, industry, and international research environments. The long-term goal is to contribute to ensuring that the population has access to safe and effective medicines. 

Project description:

The PhD position is available within the Pharmacometrics Research Group at the Department of Pharmacy, focusing on pharmacometric methods for Model-Informed Drug Development (MIDD) for regulatory decision-making.

Regulatory science is critical for ensuring safe, effective, and high-quality medicines. MIDD integrates pharmacometric modeling with regulatory decision-making, improving efficiency and robustness in drug development. This project aims to (1) evaluate model-based approaches for bioequivalence and biosimilarity through simulation studies and real data analysis, and (2) integrate causal inference methods with pharmacometrics to strengthen regulatory decisions. The work aligns with ICH M15 guidelines and addresses key challenges in regulatory science. Project outcomes will support global regulatory initiatives, enhance Sweden's leadership in this area, and contribute to the faculty's emerging research school in regulatory science. Models and methods will be developed based on pharmacokinetic and pharmacodynamic (pharmacometric) principles.

Regulatory science bridges innovation and patient access by ensuring that medicines meet stringent safety and efficacy standards. Recently published international guidelines (ICH M15) emphasize MIDD as a cornerstone for modern drug development. MIDD uses pharmacometric models to integrate drug, disease, and trial data, enabling quantitative decision-making and reducing development timelines. Despite its promise, challenges remain in model validation, bias control, and causal interpretation—particularly in regulatory contexts where decisions must be robust and transparent.

This project addresses these challenges by developing and evaluating model-based approaches for regulatory decision-making, focusing on bioequivalence and biosimilarity assessments and causal inference. The work will strengthen Sweden's regulatory science ecosystem and position the faculty as a leader in this rapidly evolving field.

Supervision and Collaboration:

The PhD student will be supervised by the Pharmacometrics Research Group at the Department of Pharmacy with a co-supervisor from the Swedish Medical Products Agency (Läkemedelsverket). This collaboration ensures that the research is directly relevant to regulatory perspectives and challenges, and provides the PhD student with unique insights into both academic research and the application of MIDD in regulatory decision-making.

Duties:
The holder of a PhD position must primarily focus on their doctoral studies. Other duties at the department, such as administration and teaching, may be included at a level not exceeding 20% of working time, which may also require knowledge of Swedish.

Qualifications:
Suitable backgrounds include a degree from the pharmacy program, a master's degree in engineering with a focus on pharmaceuticals or engineering physics, a master's degree in pharmaceutical modeling, statistics or applied mathematics, or other similar education including courses in modeling and programming (e.g., in R) (minimum 240 ECTS credits).

We place great emphasis on personal suitability as well as motivation and experience in pharmacometrics research. Experience with statistical software such as NONMEM and R is essential. Experience in clinical trial research, drug development, and regulatory science is valuable. Applicants must be able to express themselves well, both orally and in writing, in English. Furthermore, the applicant should have good collaborative skills and demonstrated ability to conduct a scientific project in a structured and methodical manner.

Applications should include:

• A cover letter
• A Europass CV (https://europa.eu/europass/en)
• Copies of relevant diplomas and transcripts
• Names and contact information for at least two references
• Any other documents the applicant wishes to submit in support of their application

Rules governing PhD students are set out in the Higher Education Ordinance chapter 5, §§ 1-7 and in Uppsala University's rules and guidelines. 

About the employment:
The employment is a temporary position according to the Higher Education Ordinance chapter 5 § 7. Scope of employment 100 %. Starting date 1 April 2026 or as agreed. Placement: Uppsala

For further information about the position, please contact: Professor Andrew Hooker, andrew.hooker@uu.se . 

Please submit your application by 13 March 2026, UFV-PA 2026/423. 

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