Rod Callaghan

Associate Director Operational Excellence 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? Flat hierarchies and short decision-making processes; open corporate culture; possibility of mobile working; unlimited contract after probationary period; 30 days' vacation; strong team spirit; personal appreciation of values; multicultural and global team and high level of collegiality; regular team events; mobility allowance; pleasant office atmosphere, modern technology standard. 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.Associate Director Operational Excellence 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? Flat hierarchies and short decision-making processes; open corporate culture; possibility of mobile working; unlimited contract after probationary period; 30 days' vacation; strong team spirit; personal appreciation of values; multicultural and global team and high level of collegiality; regular team events; mobility allowance; pleasant office atmosphere, modern technology standard. 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.

Director, Program Management Germany About Tubulis Tubulis is dedicated to developing novel, effective, and safe therapies for the treatment of cancer — one of the most pressing challenges in modern medicine. Our mission is to become a leading company in targeted therapeutics and antibody–drug conjugates (ADCs). With a passionate team, proprietary technologies, and innovative therapeutic concepts, we are ushering in a new era in the fight against cancer. Join a multidisciplinary, highly focused group working to deliver promising ADCs to patients with solid and haematological cancers. Position Overview We are seeking a proactive and committed Director, Program Management to provide strategic leadership and operational excellence for TUB-040, Tubulis’ lead program, as well as for our portfolio of innovative therapeutic programs spanning early- and late-stage clinical development. The Director will partner closely with leaders in Clinical Development, Regulatory, CMC, Biomarkers, PK, Nonclinical, Commercial, and other functions to ensure timely delivery of key milestones, robust risk management, and smooth progression of programs toward regulatory approval and commercialization. The role reports to the Vice President, Program Management . Key Responsibilities Lead the cross-functional TUB-040 program team through all stages of clinical development — from IND-enabling studies to pivotal trials and regulatory submissions. Serve as the primary point of contact for program strategy, planning, execution, and milestone delivery. Develop and maintain integrated program plans, budgets, timelines, and risk management strategies aligned with corporate objectives. Partner with functional leaders (Clinical Development, Clinical Operations, Regulatory, CMC, Biostatistics, Biomarkers, Commercial, etc.) to ensure requirements are well-defined, resourced, and executed with quality. Drive effective decision-making by preparing clear program updates and recommendations for governance committees. Provide mentorship within the Program Management function, fostering process improvements and building organizational capabilities. Encourage collaboration, guide team members, address challenges, and promote a positive working environment. Maintain open communication with the VP Program Management, team members, partners, and key stakeholders. Candidate Profile Bachelor’s or advanced degree in a relevant scientific discipline. 10+ years of experience in the biotechnology or pharmaceutical industry, with significant program/project management leadership. Demonstrated success advancing programs through multiple phases of clinical development (IND/CTA, Phase I–III, BLA/MAA, launch, lifecycle management). Proven expertise in late-stage development and pivotal trials. Comprehensive knowledge of clinical development, regulatory requirements, GxP, CMC, nonclinical, and commercialization aspects. Strong leadership, organizational, and interpersonal skills with the ability to inspire and motivate cross-functional teams. Excellent communication and presentation skills; able to synthesize complex data and present compelling updates to leadership and stakeholders. Proficiency with project management tools (MS Project, Excel, PowerPoint, Think-Cell). Self-starter with strong problem-solving skills; comfortable working in a fast-paced, dynamic environment. Fluent English (written and spoken); German is a plus. Why Join Us Flat hierarchies and short decision-making processes. Open corporate culture with mobile working options. Unlimited contract following probation, plus 30 days of vacation. Mobility allowance, modern technology, and a pleasant office environment. Strong team spirit, appreciation of individual contributions, and regular team events. Work alongside a multicultural, global team passionate about advancing next-generation cancer therapies.

Manager QA GCP/GLP About Tubulis At Tubulis , we are shaping a new generation of antibody-drug conjugates (ADCs) designed to bring safer, more effective treatments to patients with cancer. By combining proprietary conjugation technologies with deep expertise in biologics, we create targeted therapeutics that unlock the full potential of ADCs. Join a passionate, multidisciplinary team committed to excellence, innovation, and improving patient outcomes worldwide. About the Role We are seeking an experienced Manager QA GCP/GLP to join our Quality Assurance team. In this role, you will support the development of our innovative ADC pipeline and clinical programs, ensuring compliance with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and all relevant regulations. Working closely with internal stakeholders and external partners, you will drive quality standards across research, development, and clinical activities. Key Responsibilities Design and maintain a global GCP audit program in collaboration with the Director, QA–GCP. Manage vendor qualification programs for assigned suppliers and service providers. Plan, execute, and deliver audits in the GCP area (all clinical phases, suppliers, systems, and documentation) to assess compliance with Tubulis SOPs and international regulations (ICH, CTR, FDA, EMA, national). Oversee audit activities for GLP vendors and review/approve GLP quality documentation provided by suppliers. Act as a subject matter expert, offering GxP guidance and interpreting regulations to identify risks, trends, and improvement opportunities. Represent QA in internal forums, including Tubulis trial team meetings, as assigned. Act as the QA counterpart for GCP/GLP vendors, addressing and resolving quality-related issues. Support regulatory inspections (preparation, hosting, and follow-up). Contribute to the development and maintenance of the Quality Management System (QMS) for GCP/GLP in collaboration with the Director, QA–GCP. Your Profile Bachelor’s or Master’s degree in a Life Sciences or Medical discipline. Minimum 5 years’ experience in Quality Assurance for GCP within the biotech or pharmaceutical industry. Proven experience auditing GCP vendors, including CROs, laboratories, and clinical trial sites. Experience auditing or overseeing audits of GLP vendors is an advantage. Fluent English (written and spoken). Strong knowledge of international GCP and GLP regulations and guidelines (EU, MHRA, FDA), or a willingness to develop GLP expertise. Excellent communication, problem-solving, and stakeholder management skills. Why Join Us Flat hierarchies and quick decision-making in an open, collaborative culture. Flexible working options, including mobile working. Unlimited contract after probation, with 30 days’ vacation. Competitive compensation and mobility allowance. A supportive, multicultural team with a strong sense of collegiality. Regular team events and a modern working environment. Be part of our mission to deliver breakthrough ADC therapies to patients worldwide.