Senior Director - Clinical Operations (f/m/d)

Your mission

• 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.

Your profile

• 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).

Why us?

• 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!