Trainee (Pharmacokinetic studies of biosimilars in trial registries: retrieval and evaluation)

The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU), located in Amsterdam. It is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.

Traineeship: Pharmacokinetic studies of biosimilars in trial registries (retrieval and evaluation)

This traineeship placement is open in the European Medicines Agency (EMA) Scientific Advice Office. We are looking for motivated, qualified recent graduates or students on an Erasmus+ or other programme, or PhD students or Master's students (who posses a previous degree), who are interested in gaining experience and contribute to the Agency’s work for every patient in Europe. The purpose of a traineeship at the Agency is to perform tasks that are predominantly in the interest of the trainee’s training and principally serve to increase the trainee’s knowledge and to gain relevant experience.

Placement description

The successful candidate will conduct research, under the supervision and guidance of experienced colleagues, through public clinical trial registries and internal EMA regulatory resources on the development of biosimilar medicines, leading to a publication. Biosimilars have been introduced to lower the price of original biologics. However, hardly any independent research is published on how biosimilars are developed. One of the most contentious issues in the regulation of biosimilars is the link between structural and functional characteristics of the pharmaceutically active protein on the one side, and clinical efficacy and safety of the authorised biosimilar medical product on the other side. In their decision-making, regulators mostly rely on information from biosimilar developments that have reached a marketing authorisation application (MAA) stage.

The goal of the research is to identify comparative biosimilar pharmacokinetic (PK) studies in a comprehensive manner, understand what portion of these studies meet their primary PK endpoints, what portion have reached an MAA stage in the EU and how information on the quality attributes, that underpin regulatory decisions to start the PK comparability study, can be retrieved from the registry records. The trainee will develop the core data sheet using multiple methodologies including supervised machine learning, contribute to interpretation of the results, and is expected to become one of the authors on a peer-reviewed publication.

Learning outcomes

• To gain in depth familiarity with the EMA Clinical Trials Information System (CTIS) and public clinical trial registries
• To gain in depth knowledge of biosimilar and overall medicine development and regulatory assessment and authorisation
• To gain an understanding of the EMA scientific advice to medicine developers and other Agency processes

Eligibility criteria

To be eligible for consideration for this placement, you are required to:

1. enjoy full rights as a citizen of a European Union Member State or Iceland, Lichtenstein and Norway;
2. possess a university degree in clinical pharmacology, biomedical sciences, or any other life sciences (minimum of three years or more) that must have been obtained between 6 May 2025 and 6 May 2026 or be a university student on an Erasmus + or a similar programme or a PhD student or a Master's student with a previous fully finished degree in the areas mentioned before.
3. a thorough knowledge of English (at least level C1) and good knowledge of other official EU language (at least B2) of the Common European Framework for Languages

Additional skills

Strong analytical skills; diligent and systematic approach to work; high attention to detail; and a solid understanding of scientific methodology.

Behavioural competencies

You will demonstrate the following behavioural competencies:

• Communication skills
• Interpersonal skills
• Working with others
• Adaptability
• Research and analytical skills
• Learning and development

Conditions of traineeship

The traineeship is offered for 10 months (1 October 2026 – 31 July 2027) and takes place at the Agency’s premises in Amsterdam with possibility for teleworking up to 40% of working time from The Netherlands and occasional teleworking from outside The Netherlands. Traineeships are offered for either full-time or part-time (80% or 50%) if combined with university studies.

The Agency pays a monthly stipend of €2,049.77 for a full-time traineeship (reduced accordingly for 80% or 50%) and a travel contribution upon joining the Agency.

Each trainee will have a mentor at the Agency who will guide the trainee through the programme.

What we offer

• Meaningful work contributing to protecting the health of every individual and animal in Europe within multinational, multidisciplinary team
• Development opportunities (e.g. internal mobility, mentoring, peer coaching, career reflection programme, etc.)
• Work-life balance (flexible working arrangements, teleworking, generous annual leave plus official holidays)