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Associate Director Operational Excellence (m/f/d)

Tubulis GmbH

Roles & Responsibilities

  • 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 operational excellence, quality, or process improvement
  • In-depth knowledge of ICH-GCP and regulatory requirements relevant to oncology trials
  • Experience with authority inspections (FDA, EMA, MHRA) and leading cross-functional improvement initiatives in a biotech/start-up environment

Requirements:

  • 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 to identify process weaknesses and implement improvements; draft and revise SOPs
  • Champion risk-based approaches in clinical operations, including CAPA oversight and support for inspection readiness and regulatory inspections

Job description

Be part of our team
We are seeking a highly experienced Associate Director of Operational Excellence (GCP) to lead continuous improvement efforts across our clinical trial operations and ensure adherence to the highest standards of GCP compliance. The position will be within the Quality Assurance (QA) department.

We are a dedicated QA team supporting our development of antibody-drug conjugates (ADCs) and clinical trials with a strong focus on reliable processes and patient safety. Working closely together, we ensure that quality and compliance are part of every step, from research to clinical application. Our team values open communication, practical problem-solving, and a shared responsibility for doing things right. If you enjoy working in a supportive environment where your contributions make a real difference, we’d be happy to hear from you.
Your mission
  • 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.
Your profile
  • 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)
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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