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 I - Mechelen, BE
Scope of the job
You will support the Development team in contributing to the clinical evaluation of new drug candidates through the operational management of phase I clinical trials.
You will lead 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:
• Initiate and coordinate the vendor selection process;
• Be the primary contact person for selected vendor and ensure high quality oversight according to study plans, timelines & budget;
• Provide operational input into the design of phase 1 studies;
• Coordinate study document creation (Clinical Study Protocol, Informed Consent Form, Clinical Study Report,…);
• Review and/or approve study documents (Monitoring Plan, TMF plan, Data Management Plan, Safety Plan, eCRF, SAP, Mock TLFs, DTA/DTS,…);
• 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, PK/PD lead, DM, Stat, CMC,…);
• Organize and lead cross-functional Internal Clinical Study Meetings as well as with the vendor;
• 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;
• Actively initiate and participate in Process Improvement initiatives;
Who are you ?
• You have obtained a Master’s degree or a PhD in life sciences;
• Willingness to travel;
• You have a good understanding of early drug development;
• You have at least 3 years of experience in phase I clinical study management;
• Strong knowledge in running early phase clinical trials - and in particular First In Human studies - in healthy volunteers as well as patients is an asset;
• 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;
• You are Results oriented with a pragmatic and hands-on approach;
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…!