Role Overview The
Team Lead, Site Operations is the formal people leader and functional process owner for assigned Site Operations personnel within Clinical Operations. The role is accountable for line management, resource planning, capability development, functional quality, and the design, maintenance, and continuous improvement of designated Site Operations and Clinical Operations processes. The Team Lead enables consistent, compliant execution across Germany and the United States and partners closely with Clinical Operations Leads to ensure appropriately skilled resources are assigned to studies.
Reports to: Vice President, Clinical Operations
Location: Remote
Basic Qualifications:- 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
Preferred Qualifications:- 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.
In this Role You Will:People Leadership and Talent Development
- 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.
Resource and Capacity Management
- 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.
Functional Process Ownership and Operational Excellence
- 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.
Quality, Compliance, and Site Operations Expertise
- 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.
Qualified candidates will participate in a structured interview process, which includes: - An initial recruiter phone screen (conducted via video)
- A recruiter-facilitated introduction and interview with the hiring leader and key stakeholders (via video)
- A final-stage interview, which may include an in-person meeting at our U.S. Headquarters in Houston, TX
What do we offer? At Immatics, we believe in investing in our team's health, safety and well-being. Here's what you can expect if you join Immatics:
Comprehensive Benefits: - 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 at 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.
