Clinical & Regulatory Project Manager - Leiden (NL)

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

We are in the business of changing lives. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class medicines. With capabilities from lab to patient, including a decentralized cell therapy manufacturing platform, we are committed to challenging the status quo and delivering results for our patients, employees, and shareholders. Our goal is not just to meet current medical needs but to anticipate and shape the future of healthcare, ensuring that our innovations reach those who need them most.

We pioneer for patients. 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-happener’.

We are looking for a Clinical & Regulatory Project Manager to join our team in Leiden (NL).

Scope of the job

In this pivotal role, you will lead project management activities at the crucial intersection of Regulatory Affairs and Clinical Development across our CAR-T cell therapy programs. You'll play a critical role in integrating cross-functional planning, managing complex regulatory-clinical workstreams, and driving alignment across key teams to support efficient execution and timely achievement of program milestones.

Your role

• Act as a key integrator, collaborating closely with the Clinical Development Program Lead, Cell Therapy Development Team Leader’ (CDTLs), Regulatory Affairs, Clinical teams (Clinical Development, Clinical Operations, Clinical Science), and functional representatives from e.g. Data Science, Translational Science, Quality, CMC, and Technical Operations to ensure seamless execution of integrated regulatory and clinical strategies and planning.

• Structure and manage cross-functional project plans, clearly defining critical paths, milestones, dependencies, and risks.

• Drive interdisciplinary projects and discussions, proactively identifying and resolving bottlenecks, ensuring timely decision-making and execution.

• Serve as a trusted advisor and central point of contact to key stakeholders of the program(s) in your scope, serving as an important voice in balancing rapid progression with risk-awareness, and ensuring awareness of both regulatory and clinical standards incl. GCP, where relevant.

• Utilize project management tools (e.g. MS Project, Smartsheet) to effectively monitor, track, and report project status and KPIs, ensuring transparency and accountability across teams.

• Foster process excellence, continuously optimizing workflows and facilitating lessons learned to enhance future program execution.

Who are you ?

• 5-7 years of proven experience in a Development function, preferably clinical development/operations/science, or regulatory affairs, with a strong track record in driving complex, cross-functional projects to successful completion.

• Expertise in clinical-regulatory integration and cross-functional project management, with hands-on proficiency in relevant tools and methodologies.

• Exceptional analytical and organizational skills, capable of structuring complex workstreams and clearly communicating actionable plans.

• Demonstrated ability to lead interdisciplinary discussions, resolve conflicts effectively, and manage multiple priorities while maintaining focus on critical deliverables.

• Strong risk-awareness, capable of balancing speed and thoroughness to drive informed decision-making.

• Excellent verbal and written communication skills, able to articulate complex information clearly and concisely to diverse stakeholders.

What’s in it for you ?

At Galapagos, we prioritize your continuous growth and development, fostering a culture of empowerment. Our employees are the driving force behind our mission to lead in pharmaceutical research and innovation.

We offer a competitive compensation package and a supportive work environment with strong focus on your health and well-being. Join us in our journey towards sustainability, as we strive to make a lasting impact on both the industry and the planet.

Galapagos is dedicated to ensuring equal employment opportunities. Our hiring decisions are based on merit, considering qualifications, skills, performance, and achievements. We strictly prohibit discrimination against any employee or job applicant based on personal characteristics that are unrelated to their job.

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