SeniorFull TimeEN
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
Country Study Start-up Team Leader (cSTL)
Roche Nederland B.V., Woerden
The Opportunity
At Roche, we advance science so that we all have more time with the people we love. In our Global Clinical Operations (PDG) team, we are looking for a Country Study Start-up Team Leader (cSTL) to take on a dual-impact role that is vital to our mission. You will be the driving force behind clinical trial submissions while simultaneously serving as a People Leader (for +- 30% of your time), guiding a dedicated team to success in our country delivery operations.
In this pivotal role, you will balance strategic oversight of study start-up with hands-on leadership in regulatory submissions and people management. Your work ensures that we deliver innovative medicines to patients faster and more efficiently by streamlining the bridge between clinical design and site activation.
In this role, you will:
Lead the country strategy for study start-up, driving efficiency and innovation to ensure timely site activation.
Drive clinical trial submissions and regulatory coordination, managing complex submission packages and responding to Health Authority queries.
Serve as a People Leader for approximately 30% of your time, providing coaching, support, and professional development to your direct reports.
Architect and oversee the management of Informed Consent Forms (ICF) and clinical site documentation to ensure global compliance.
Champion process innovation by identifying opportunities for automation to improve trial initiation timelines.
Collaborate with global stakeholders, including CROs and Health Authorities, to harmonise systems and influence the local start-up environment.
Manage clinical site budgets and contracts, ensuring financial and legal alignment through expert negotiation.
Who you are
You are a proactive, visionary leader who combines deep technical expertise in clinical submissions with a genuine passion for developing others. You thrive in complex, matrixed environments and possess the analytical prowess to turn data into strategic improvements.
To be successful in this role, you bring:
Extensive industry expertise: Proven experience in clinical trial start-up and regulatory submissions, with deep knowledge of ICH-GCP and EU CTR.
Transformation leadership: A track record in coaching, mentoring, and leading high-performing teams to deliver significant business impact.
Advanced scientific background: A University degree (MD, PhD, MS, or BS) in life sciences; a postgraduate degree is highly desirable.
Technical proficiency: Experience navigating complex clinical systems such as Veeva Vault, CTIS, and RIM.
Exceptional communication: The ability to influence and partner with stakeholders, from local operational teams to global executive leadership.
Language skills: Mandatory fluency in English and fluency in Dutch is strongly preferred
Why Roche?
For over 125 years, Roche has been working towards a healthier future with one clear goal: "Doing now what patients need next". We believe that the greatest medical challenges can only be solved through intensive collaboration with healthcare professionals and patients.
Our impact goes beyond healthcare; we also take full responsibility for our planet. For instance, since 2025, all our locations have run on 100% sustainable electricity—a major milestone in our ambition to be fully climate neutral (net zero) by 2045. At Roche, you are not just working on the healthcare of tomorrow, but also on a healthy, sustainable world.
What you get from us:
A workplace where fun and social impact come together.
An organisation where your expertise is valued, and you can make autonomous decisions within your team.
The chance to work with products that are fundamentally transforming oncological care.
Abundant opportunities for personal and professional growth; we invest in your unique path.
Diversity and inclusion are at our heart; we invite you to be your authentic self.
Excellent benefits including a half 13th month, performance-based bonus, lease car, 30.5 days of holiday, and participation in our stock program.
Ready to make an impact?
Are you excited about this role and do you recognize yourself in this profile? Feel fry to apply via the "apply now button". If you have any questions, please contact our Talent Acquisition Partner, Matthijs van Heusden, at +31 6 41607509 or matthijs.van_heusden@roche.com.
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
