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Clinical Study Lead (m/f/d)

Tubulis Technologies

Munich, Germany · Germany · Bavaria, Germany

Posted on Sep 13, 2025

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Be part of our team

The Clinical Trial Lead (CTL) leads and manages the execution of one or more clinical trials in a fast-paced, dynamic environment. The CTL is responsible for ensuring trials are conducted on time, within budget, and in compliance with regulatory requirements, Good Clinical Practice (GCP), and company Standard Operation Procedures (SOPs).

The ideal candidate will have hands-on experience in managing global Phase 1-3 clinical trials and possess a strong understanding of biotech/ pharmaceutical product development. This role requires both strategic oversight and day-to-day operational execution across all aspects of clinical trial management.

Your mission

Lead cross-functional study teams to ensure successful clinical trial execution.
Develop and manage study timelines, budgets, enrollment plans, and risk mitigation strategies.
Oversee protocol development, CRF design, and operational documentation.
Select, onboard, and manage CROs, central labs, and other third-party vendors.
Oversee site feasibility, selection, and initiation processes.
Monitor enrollment progress, patient retention, and site performance.
Ensure compliance with ICH-GCP, local regulatory requirements, and internal SOPs.
Maintain and oversee an inspection-ready Trial Master File (TMF).
Support audit readiness and participate in health authority inspections as needed.
Provide regular trial status updates to senior management and cross-functional stakeholders.
Collaborates with clinical data management, medical, regulatory, and safety teams.
Proactively identify and resolve operational issues and risks.
Lead trial close-out activities, including final data review and archiving

Your profile

Bachelor’s degree in Life Sciences or a related field. Advanced degree preferred.
4+ years of experience in clinical research, with 2 years in trial management.
Experience in the biotech and/or pharmaceutical industry is required.
Strong knowledge and understanding of GCP/ICH guidelines, regulatory requirements, and industry best practices.
Proven track record in managing CROs, external vendors, and global clinical trials.
Excellent organizational, communication, and problem-solving skills.
Ability to manage multiple priorities and work effectively in a dynamic and collaborative environment.
Demonstrated ability to work both independently and within cross-functional teams.
Willingness to travel as needed (approximately 20%).
Oncology trial experience is a plus.

Why us?

At Tubulis, curiosity and innovation drive us to transform cancer treatment. We are a fast-growing biotech where science meets passion—and where you have the chance to grow with us.

Impact that matters: Contribute to breakthrough therapies.
Global mindset: Work in an international, diverse team.
Grow & thrive: Develop your career in a supportive, fast-moving environment.
Innovation every day: Push boundaries with cutting-edge science.

At Tubulis, your ideas matter, your growth matters—and together, we make a difference.

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About us

The development of novel, effective and safe therapies for the treatment of cancer is one of the main challenges for modern medicine. We want to drive this process forward. The main goal of Tubulis is to become a leading company in the field of targeted therapeutics and antibody-drug conjugates (ADCs). With a strong team, our own technologies and innovative therapeutic concepts, we are ushering in a new era in the ongoing fight against cancer and share the vision of helping patients world-wide. Be part of a multidisciplinary and focused team, that works towards getting novel promising ADCs to patients with solid and hematological cancers.

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