Associate Director Non-clinical Evaluation, Leiden/NL

Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices across Europe and headquartered in Belgium (Mechelen)

We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We want to challenge the impossible. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you: The ‘make-it-happeners’.

We are looking for an Associate Director Non-clinical Evaluation

Scope of the job

As Associate Director Non-clinical Evaluation you join the Non-Clinical Evaluation Team (NCET) in the cell therapy department in the Leiden Bio Science Park. You play a pivotal role in the development of innovative cell therapy modalities for cancer using the most advanced, state-of-the-art methodologies. You enjoy sharing ideas, you have a “let’s do it” attitude and you like working in a diverse team. You also enjoy working in close collaboration with various departments within our company and other stakeholders to ensure the non-clinical aspects of our clinical candidates are covered.

As a senior scientific expert with experience in documentation, regulatory filing and CAR-T/TCR-T cell therapy, you are key in supporting the development of our clinical CAR-T programs.

Your role

The NCET department plays an important role in the transition from discovery CAR-T modalities towards clinical studies. Within this role, the Associate Director NCET supports the development towards first-in-human studies covering the non-clinical aspects of the CAR-T candidates. This can be either during the progression of ongoing clinical trials as well as new CAR-T candidates coming through the discovery pipeline.

The Associate Director:

• Outsources, designs, initiates and monitors the progress of nonclinical studies for cell therapy.
• Coordinates with various teams within GLPG and other stakeholders to execute in-house non-clinical studies.
• Reviews study data and takes ownership of the full documentation of all study results for CTA/IND filing.
• Prepares for and participates in meetings with regulatory authorities.
• Collaborates closely with a non-clinical writer
• Keeps up-to-date with relevant literature, technology, academic discoveries, and industry developments.

The Associate Director Non-clinical Evaluation reports to the Head of NCET. Remote working is possible, but frequent presence in Leiden is required.

• PhD degree in Life Sciences or related discipline
• At least 5 years of experience in the biotech/pharmaceutical industry
• Knowledge of (CAR-T/TCR-T) cell therapy/cancer biology
• Experience in regulatory filing for EMA or FDA
• Knowledge about GLP is a plus
• Ability to be flexible with changing priorities
• Previous experience in project management and strong in building partnerships
• Proficient in English

What’s in it for you ?

You will be part of a fast growing and amazing company. As ‘make-it-happener’ you will get all the support you need to make your job successful. At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.

We are Galapagos : together we can make it happen…!