Your mission

• Oversee the assigned clinical trial(s) in the field of immune-oncology therapies on a global/regional level. Ensure consistent, high-quality execution of the trial and vendors within timelines and on budget. 
• Oversee and contribute to the development of clinical trial documents (protocol, ICF, CSR) in alignment with regulatory and ethical standards and the development of study management documents (e.g., oversight plan, risk management plan etc.).
• Oversee study feasibility, site selection, submission to Ethics Committees, investigator recruitment, site activation (green light), patient enrolment and monitoring processes; oversee Clinical Research Organization (CRO) & vendor selection and management i.e., clinical, data management, statistics, drug supply and central laboratory services incl. development of associated process management plans. 
• Act as primary contact for CRO and vendors involved in the clinical trial and perform vendor oversight; oversee risk management and issue resolution, perform periodic review of protocol deviations and escalate to Director Clinical Operations/QA, and perform co-monitoring visits, if required.
• Ensure accurate trial documentation and inspection readiness of assigned trial, participate in internal audits and HA inspections as required.
• Contribute to the preparation and presentation of project information at investigators meetings.
• Ensure compliance with regulatory requirements, the ICH-GCP guidelines and the respective procedures (i.e., policies, SOPs, instructions), identifies and suggests potential process improvements. 
• Provide training to the CRO team and mentor other CatalYm staff working on the assigned trial e.g., regional CTM(s), Clinical Trial Specialist(s) or Clinical Trial Associate(s).

Your profile

• Bachelors or Masters degree in life sciences with at least 5 years of experience in a clinical study management role within Biotech, Pharma or CRO organization; experience with oncology studies is a must, immune-oncology studies a plus.  
• Extensive experience in vendor selection and management required, experience in clinical monitoring is an asset.
• Excellent knowledge and understanding of clinical trial processes, methodology and regulations (ICH-GCP, and any local regulations). 
• Experience as study team leader with ability to work within a dynamic team and within matrix structure is an asset.
• Excellent organizational and planning skills; able to effectively manage multiple competing priorities, identify and solve conflicts (critical thinking and risk analysis), meet deadlines without direction.
• Good negotiator and communicator, strong interpersonal and analytical skills.
• Proactive, hands-on working style.
• Proficient computer skills (excellent knowledge level of MS Excel and MS PowerPoint) and fluent in English with excellent oral and written skills; good level of German.

Why us?

• Creative working in X-functional teams
• Short communication channels
• Dynamic and goal-orientated environment
• Open and appreciative corporate culture in a multicultural environment
• Flexible working hours office and home office based enable time management on your own terms
• Limited domestic and international travel required, when necessary

About us

CatalYm is a biotech company based in Martinsried near Munich, developing innovative immunotherapies to transform cancer patients’ lives by effectively engaging their own immune systems to combat this malignant disease. We are now advancing to Phase 2b studies to confirm visugromab, our lead antibody, that has demonstrated durable anti-tumor efficacy with long-lasting objective responses in relapsed and refractory metastatic solid tumor patients in combination with anti-PD-1 treatment. Our mission is to rapidly bring our next-generation immuno-oncology products to patients in need. Are you ready to board the fast-accelerating visugromab train in Martinsried? Then join us!