Clinical Operations Program Leader - Mechelen,BE - Leiden, NL
Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), France (Romainville), the Netherlands (Leiden), Switzerland (Basel) and in 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 Operations Program Leader.
As core member of the cross-functional Clinical Development Team (CDT), you drive decision-making and execution of clinical operations plans. You provide strategic clinical operations expertise across the lifecycle of a compound, starting from proof of concept, throughout registration and life cycle management.
- Providing strategic clinical operations expertise into the planning, execution and maintenance of the Clinical Development Plan (CDP), including the assessment of the required studies, their design, overall timelines and budget, as well as performing a risk assessment and provide risk mitigation input.
- Proposing and defining type of vendors needed (e.g. CROs and other specialty vendors) and developing strategic high-level recruitment plans (e.g. region/countries selection) in support of operational execution of the agreed strategies.
- Overseeing at clinical program level: operational delivery with regard to time, budget, and quality.
- Budget and timeline forecasting and reporting on clinical program level.
- Overseeing Clinical Study Teams to drive execution of individual studies of the CDP, and empowering Clinical Study Leaders (CSLs) to drive effective decision-making and execution of endorsed clinical study plans.
- Ensure audit/inspection readiness of allocated clinical programs at all times.
- Ensuring consistency of clinical operations aspects across studies of a clinical program
- Identifying and resolving issues at the CDT level or escalating them to the Project Team as required.
- Works closely together with the Clinical Development Leader /Translational Medicine Leader in leading the Clinical Development Team.
- Is internal primary point of contact for clinical operational strategies of assigned clinical programs.
- Works closely together with Clinical Study Teams to drive execution of individual studies of the assigned clinical program.
- Within matrix organization context, has regular contact with the line manager (LM) of the CSLs.
- Has regular contacts with external parties (partners, vendors, CROs, KOLs), and participates in meetings as required.
Who are you?
- You have a Master in life sciences and at least 10 years of experience in clinical development.
- You have proven track record of clinical operations experience (P1-3b), and strong clinical project management experience in a (bio)pharma, or CRO environment.
- You have sound knowledge of regulatory, quality and operational aspects of global clinical study/program
- You have experience in external stakeholder management and/or oversight.
- You can show excellent leadership, strategic, communicating, negotiating, and decision-making skills.
- You have experience in working in a matrix organization, and in cross-functional teams, fostering a trusting team atmosphere.
- You are able to travel per business needs.
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…!