Clinical Operations Program Lead Hematology/Oncology - Leiden (NL) or Mechelen (BE)
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 a Clinical Operations Program Lead Hematology/Oncology to join our team in Leiden (the Netherlands) or in Mechelen (Belgium).
Scope of the job
The Clinical Operations Program Lead (COPL) will be providing strategic clinical operations expertise and input into the clinical development plans and clinical development activities for multiple of our hematology/oncology indications (CAR T). Ensuring successful operational planning, execution and close out of these strategies.
- Defining the clinical operations strategy, in line with overall development strategy including the assessment of the required studies, their design, high level estimation of timelines and budget, as well as performing a risk assessment and provide risk mitigation input.
- Acquiring competitive intelligence to appropriately define clinical operations strategies.
- In collaboration with the Site Strategy team developing strategic high-level recruitment plans (e.g., region/countries selection) in support of operational execution of the agreed strategies.
- Proposing and defining type of vendors needed in support of operational execution of the agreed strategies.
- Overseeing clinical program level - operational delivery regarding time, budget, and quality:
- Responsible for coordination and implementation of agreed strategy.
- Overseeing individual Clinical Study Teams (CST) to drive execution of the plans.
- Ensuring consistency of clinical operations aspects across studies of a particular clinical program.
- As core member of the Clinical Development Team(CDT)/Project Team (PT), drive the decision-making and execution of clinical operations plans. Communicating program decisions and strategy back to the clinical study leader (CSL), and ensuring clinical operations functional plan alignment with the Clinical Development Plan.
- Identifying and resolving risks/issues at the CDT/PT level as well as ensuring information flow from and to CSTs.
- Ensuring audit/inspection readiness of allocated programs at all times. Interacting with Quality Management and follow up on audit/inspection reports. Ensuring a timely creation of a CAPA plan and timely CAPA closure.
Who are you ?
- Master in life sciences or similar by experience.
- At least 10 years of relevant experience in clinical development.
- Significant experience in Hematology/Oncology Clinical Development
- Proven track record of clinical operations experience, and strong clinical project management experience in a (bio)pharma, or CRO (Contract Research Organization) environment.
- Sound knowledge of regulatory, quality, and operational aspects of global clinical study/program conduct and oversight.
- Experience in external stakeholder management and oversight
- Excellent knowledge of ICH/GCP E6(R2) guidelines and other applicable regulations.
- A desire to build something special from the ground up together with energized, driven and smart colleagues to forward the pursuit of human health
General skills :
- Excellent verbal and written communication skills.
- Excellent presentation skills.
- Excellent team player.
- Strong organizational skills.
- Sound leadership, interpersonal and conflict management skills.
- Ability to lead, support and motivate a cross-functional in/external teams.
- Ability to work under high pressure and with shifting priorities.
- Fluent in English (writing and speaking).