Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), France (Romainville & Paris), the Netherlands (Leiden), Switzerland (Basel), Italy (Milano), Spain (Madrid), the UK (London), Germany (München), and in the US (Boston).
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 a Clinical Study Lead Phase II & III - Leiden, NL
Scope of the job
As a Clinical Study Lead (CSL) you support the Development team in contributing to the clinical evaluation of new drug candidates through the operational management of multinational clinical trials phase 2 and phase 3.
Leading the Clinical Study Team from initial study planning, setup and conduct until final reporting phase with overall responsibility to remain within agreed budget, timelines and expected GLPG quality standards. That means more detailed:
- Appropriate planning of budget, resources and timelines for allocated studies..
- Actively initiate and participate in Process Improvement initiatives.
- Be responsible to deliver a clinical study from initial planning, setup and study conduct until final reporting phase within agreed budget, timelines and with high quality (comply with GLPG processes, ICH-GCP and applicable regulations and guidelines).
- Initiate and coordinate the vendor selection process.
- Be the primary contact person for selected vendors and ensure high quality oversight according to study plans, timelines and budget..
- Coordinate study document creation (Clinical Study Protocol, DSMB charter, Informed Consent Form, Clinical Study Report,…).
- Review and/or approve study documents (Monitoring Plan, TMF plan, Safety Plan, eCRF, a.o.).
- Ensure proper filing and archiving of TMF - Internal single point of contact for assigned clinical studies, close interaction with functional experts involved in the clinical study (Medical Monitor, ClinPharm/PD lead, DM, Stat, CMC,…).
- Organize and lead cross-functional Internal Clinical Study Meetings as well as with the vendors - Ad hoc, act as Clinical Study representative in the Clinical Development Team.
- Interact with the Quality Monitor and follow-up on audit reports & CAPA set-up and resolution.
Who are you ?
- You have obtained a Master’s degree or a PhD in life sciences or equivalent level of qualification through education and experience.
- Willingness to travel.
- You have a good understanding of drug development as well as a solid experience of at least 3 to 5 years as clinical study manager.
- Experience in selection, contracting and maintaining overview of vendors is an asset.
- You really enjoy working in cross functional teams.
- You have excellent oral and written communication skills 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…!