Note: The job is a remote job and is open to candidates in USA. Immatics is a biotechnology company developing precision cancer immunotherapies, including TCR T-cell therapies and TCR bispecifics. The Team Lead, Site Operations leads assigned Clinical Operations personnel, manages resources and capability development, owns functional processes, and drives compliant, high-quality operational execution across Germany and the United States.
Responsibilities
- Serve as the formal line manager for assigned Site Operations personnel, including Clinical Trial Associates, Clinical Research Associates and Clinical Trial Managers, and other roles as assigned
- Recruit, onboard, coach, develop, and retain team members who meet role requirements and contribute to a high-performing, collaborative Clinical Operations culture
- Set individual objectives, provide regular and meaningful performance feedback, conduct formal performance evaluations, and support career development, succession planning, and promotion readiness
- Create an environment of trust, accountability, inclusion, and psychological safety while addressing performance or conduct concerns promptly and appropriately
- Ensure team members maintain the training, qualifications, competencies, and functional knowledge required for their assigned responsibilities
- Partner with the Clinical Operations Leads (COLs) to ensure study roles, priorities, timelines and deliverables are clear, serving as a point of escalation and receive study-performance feedback on team members
- Maintain visibility of team capacity, capabilities, workload, and development needs; lead resource forecasting and cross-study workload balancing in consultation with the Head of Clinical Operations
- Assign or reassign Site Operations personnel to studies based on portfolio priorities, required competencies, workload, continuity needs, and development opportunities, in consultation with the relevant Clinical Operations Leads
- Identify current and future capacity gaps and recommend hiring, contractor support, capability development, or other resource solutions
- Own, develop, maintain, and harmonize designated Site Operations and Clinical Operations processes, SOPs, work instructions, guidance documents, templates, and training materials in partnership with relevant stakeholders and Quality
- Ensure consistent implementation of applicable Clinical Operations processes and standards across studies and regions while accommodating appropriate local requirements in Germany and the United States
- Drive continuous improvement and global harmonization through review of lessons learned, recurring issues, metrics, audit and inspection observations, CAPAs, and user feedback
- Establish and monitor functional metrics and key performance indicators relevant to Site Operations, resource utilization, process quality, and organizational effectiveness; identify trends and implement improvement actions as appropriate
- Support organizational change, technology adoption, and process improvements that increase quality, consistency, scalability, and efficiency across Clinical Operations
- Maintain expert-level knowledge of ICH GCP, applicable regulations, clinical monitoring practices, and evolving industry expectations relevant to Site Operations
- Support functional inspection and audit readiness, including preparation of personnel, processes, documentation, and evidence of oversight; coordinate corrective and preventive actions within the function as assigned
- Provide subject matter expertise for site management, clinical monitoring, monitoring strategy, oversight models, and related Site Operations processes without assuming accountability for day-to-day delivery of individual clinical trials
- Collaborate with Clinical Operations Leads and cross-functional partners to identify systemic risks, process gaps, and capability needs that may affect multiple studies or the Clinical Operations portfolio
- Model transparent communication, reliable execution, sound judgment, and collaborative leadership across the global Clinical Operations organization
Skills
- Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related discipline required
- 8 to 10 years of experience in Clinical Operations or related functions within biotech or pharmaceutical industries, with 4 to 5+ years of that experience in direct people leadership, managing clinical operations professionals
- Applicants must be authorized to work in the United States without the need for current or future sponsorship
- Master's degree in Life Sciences, Pharmacy, Nursing, or a related discipline
- 5+ years of clinical monitoring experience within the pharmaceutical or biotechnology industry, including roles as a Clinical Research Associate and/or Clinical Trial Manager
- Demonstrated late phase experience in oncology
- Experience in cell therapy or other complex investigational therapies strongly preferred
- Strong working knowledge of ICH-GCP, FDA regulations, and global clinical trial requirements
- Demonstrated ability to lead cross-functional initiatives and influence stakeholders across multiple organizational levels
- Proven experience managing resources, priorities, and competing business demands in a dynamic environment
- History of driving operational improvements and implementing innovative approaches within Clinical Operations
- Experience supporting regulatory inspections and audit readiness activities
Benefits
- Remote work arrangement
- Competitive rates for Health, Dental, and Vision Insurance
- 4 weeks of vacation, granted up front each year and prorated for first and last year of employment
- 12 company paid holidays
- 7 days of sick time
- 100% employer-paid life insurance up to 1x annual salary, up to one hundred thousand dollars
- 100% employer-paid short- and long-Term disability coverage
- 401(k) with immediate eligibility and company match
- The company will match 100% of your contributions up to 3% of your base salary for the first two years of employment, 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment.
- Partially paid parental leave for eligible employees
- Additional voluntary employee-paid benefits and services, including accident, hospital indemnity, and critical illness insurance, as well as identity theft protection and pet insurance
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