Director ClinOps, CTM (m/f/d)

Director Clinical Operations is responsible for the management and oversight of one or more complex clinical trials, from planning through execution and reporting.

Key Responsibilities:

• Develop and implement strategies for the assigned clinical trials
• Oversee the set- up and conduct of clinical trials to ensure compliance with the clinical trial protocol and overall clinical objectives and inspection readiness
• Lead/manage the CatalYm Trial Team including cross-functional alignment concering delieverables, timelines and quality (Medical Services, Regulatory Affairs, Trial Supplies, Bioanalytics, Project Management, Clinical Safety)
• Oversee the performance of clinical Sites and Service Providers
• Manage trouble-shooting and shortcomings of Service Providers and Clinical Sites and timely escalation to Senior Management
• Drive the establishment of the trial-specific risks, hold regular risk assessment meetings, implement mitigations, corrective and preventive actions
• Manage the protocol deviation (PD) management process, develop and implement the Protocol Deviation Management Plan, hold regular meetings, and implement actions derived from the ongoing assessment of PDs
• Contribute to the selection and negotiations/contracting with Service Providers
• Prepare and managing budgets for the assigned clinical studies
• Ensure data quality and integrity through regular review and evaluation of all clinical data
• Prepare and present regular updates and reports to senior management
• Manage the relationship with Investigators /Site trial teams in close cooperation with the Medical Lead
• Develop and implement trial-specific Sponsor Oversight and Communication Plan, and the Blinding / Unblinding Plan (if applicable)
• Manage the development and review of trial-related documentation including case report forms, functional plans, manuals, charters, and patient information / informed consent forms
• Ensure all (serious) adverse events are reported appropriately and in a timely manner
• Collaborate with various departments and Service Providers to ensure trials are completed on time and within budget
• Organize activities and stakeholders in context of database closure, interim and final analysis and reporting
• Oversee the topicality, completeness and correctness of the Trial Master File
• Oversee the closure of the assigned clinical trials including final budget reconciliation and archiving

Qualifications

• Proven work experience as a Clinical Trial Manager for complex trials
• Excellent understanding of Good Clinical Practice (GCP) guidelines
• Knowledge of clinical trial regulations, guidelines and ethical standards to ensure compliance at all stages of the trials
• Knowledge of data management, statistical and reporting principles in clinical trials
• Excellent organization and planning skills to manage all aspects of a clinical trial, from the design stage to the final report writing, and archiving
• Ability to multitask and manage multiple contributors/stakeholders at the same time
• Strong leadership and team management skills to coordinate multidisciplinary teams and ensure that all team members are on the same page
• Attention to details and analytical thinking to ensure accurate data collection, interpretation and reporting
• Problem-solving skills to address any issues or complications that may arise during all stages of the trials
• Excellent interpersonal and communication skills
• At least BSc degree or comparable education in Life Science or related field.
• This position requires regular on-site presence in Munich; therefore, candidates should be based in the Munich area.

• Contribute directly to the success of cutting-edge oncology programs.
• Be part of an agile, collaborative biotech environment with visible impact.
• Enjoy flexibility, ownership, and professional growth within a supportive culture.