Country Study Start Up Team Leader — Roche

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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. The Position 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,