Associate Director, Operational Excellence

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October 13

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Tubulis GmbH

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Biotechnology • Pharmaceuticals

Tubulis GmbH is a biotechnology company specializing in the design and development of next-generation antibody–drug conjugates (ADCs) for cancer treatment. The company leverages proprietary platform technologies to generate uniquely matched ADCs with improved biophysical properties, durable on-tumor delivery, and strong preclinical anti-tumor activity. Its lead clinical programs, TUB-040 (anti-NaPi2b) and TUB-030 (anti-5T4), target high-need solid tumor indications, and Tubulis advances both its proprietary pipeline and partnered programs with the aim of expanding the therapeutic potential of ADCs for patients and collaborators.

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

📋 Description

• Lead strategic initiatives to optimize clinical trial processes and drive operational efficiency across GCP-regulated activities. • Establish and maintain GCP-compliant process frameworks tailored to early-phase oncology trials. • Collaborate with cross-functional teams (e.g., Clinical Operations, Clinical Development, QA, Project Management) to identify process weaknesses, bottlenecks and implement process improvements. • Conduct gap analyses to identify potential business process and / or systems deficiencies. • Draft new SOPs and revise existing documents to reflect optimized, compliant and scalable practices. • Facilitate SOP review cycles, incorporating stakeholder feedback and ensuring alignment with internal policies and applicable regulatory requirements. • Analyze operational data and performance metrics to drive data-informed decision making and promote accountability. • Champion risk-based approaches in clinical operations, including proactive risk identification, mitigation planning, and CAPA oversight. • Support inspection readiness activities and serve in close collaboration with QA and the operational teams as a key contributor in internal audits and regulatory inspections.

🎯 Requirements

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related field • Minimum of 10 years of experience in clinical research, with at least 5 years in an operational excellence, quality, or process improvement role. • Extensive expertise in crafting process documents and translating the requirements of operational departments into practical, streamlined, and compliant process descriptions. • In-depth knowledge of ICH-GCP and regulatory requirements relevant to oncology trials. • Strong analytical skills with a demonstrated ability to translate data into operational insights. • Proven success in leading cross-functional improvement initiatives in a fast-paced biotech or start-up environment. • Excellent communication and facilitation skills; ability to influence without authority. • Fluent in English, oral and written communication. • Must have worked in a biotech ideally start-up environment. • Experience with authority inspections (FDA, EMA, MHRA).

🏖️ Benefits

• 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.