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!
Senior Director - Clinical Operations (f/m/d)
Festanstellung, Vollzeit · Planegg-Martinsried
Coordinate and oversee the planning and execution of one or more clinical program(s) conducted within the region and provide leadership to program directors overseeing several studies in dedicated indication programs.
Oversee planning, execution and reporting of clinical indication programs including budget, timelines and oversight of vendor performance, scope of works and budgets in the region.
Ensure that the execution of all clinical trials for the indication program within the region is done with high quality, on time, and within budget.
Global coordination and alignment of activities across regions for one or more programs.
Manage and develop staff, including Program Directors and their team of Clinical Trial Managers (CTMs) and Clinical Trial Associates (CTAs) in the region.
Identify/resolve cross-functional issues and regional issues in study implementation and ensure operational consistency and standards across all clinical studies within the region for the program(s).
Provide regular reports on status, potential issues and mitigation measures to the Head Clinical Operations.
Contribute to the strategic planning of future clinical studies, development program(s) and ensure operational feasibility.
Act as point of escalation for the program directors as well as for CROs and vendors in case of challenges.
Oversee risk management and issue resolution of the program(s) in the respective region.
Maintain and improve global collaboration within Clinical Operations and cross-functionally collaborate with other functions in the program(s).
Ensure program compliance with Good Clinical Practice (GCP), CatalYm`s SOPs and any applicable legislation.
Oversee process improvement and SOP development in the region.
Replacing the Head of Clinical Operations in various functions as advised, during vacation periods, business travel, etc.
Bachelor's or Master's degree in Life Sciences with at least 10 years of experience in a clinical trial management role within a biotech, pharma or CRO organisation; min. 3 years in clinical programme oversight, oncology trial experience a must, immuno-oncology trials a plus.
Extensive experience in vendor selection and management required, clinical trial oversight, experience in clinical monitoring is an asset.
Excellent knowledge and understanding of clinical trial processes, methodology and regulations (ICH-GCP and any local regulations).
Experienced team leader with the ability to work in a dynamic team and within a matrix structure.
Excellent organisational and planning skills; able to effectively manage multiple competing priorities, identify and resolve conflicts (critical thinking and risk analysis), meet deadlines without direction.
Good negotiator and communicator with strong interpersonal and analytical skills.
Fluent in English with excellent verbal and written skills; good level of German.
Good computer skills (excellent knowledge of MS Excel and MS PowerPoint).
Impact & Growth - Be part of a dynamic, goal-oriented company where your contributions truly make a difference.
Innovation - Work on groundbreaking immuno-oncology therapies with a mission-driven team.
Collaboration & Culture - Enjoy a multicultural, open, and appreciative work environment and direct communication channels.
Additional Benefits - Competitive compensation, professional development opportunities, and more!
Join us in shaping the future of cancer therapy!