Associate Director, TMF Strategy & Operations

Technical Resources International, Inc.; North Bethesda (MD); Hybrid; USD 130,000 - 155,000; Full time

Benefits offered by this job

Hybrid work schedule

Job summary

Technical Resources International, Inc. is seeking an Associate Director, Clinical Operations-TMF to lead TMF strategy and governance from Bethesda, MD, with a hybrid work arrangement. You will oversee TMF health across multiple trials, ensuring inspection readiness and regulatory alignment.

The role requires senior leadership experience in TMF and a strong background in FDA, GCP, and ICH guidelines, coordinating with executives and sponsors to deliver compliant TMF programs.

Qualifications

• 10 years minimum experience in the pharmaceutical or biotechnology industry including CRO or global trials.
• At least 6 years owning TMF strategy and leading TMF operations and teams.
• Master's Degree in life science or related field; advanced degree a plus.

Responsibilities

• Owns TMF strategy, quality, inspection readiness, systems/processes, staff leadership, and client oversight.
• Provide strategic and operational leadership for the TMF function across programs.
• Establish, maintain, and improve TMF governance, processes, procedures, and quality standards.
• Oversee TMF health across trials and serve as senior TMF contact for executives.
• Develop TMF plans for new studies including structure, filing conventions, and milestones.

Skills

TMF strategy

Leadership

Quality management

Regulatory knowledge

Cross-functional collaboration

Education

Master's Degree

Bachelor’s Degree in life sciences

Job description

Technical Resources International, Inc. is seeking an Associate Director, Clinical Operations-TMF to lead TMF strategy and governance from Bethesda, MD, with a hybrid work arrangement. You will oversee TMF health across multiple trials, ensuring inspection readiness and regulatory alignment.

The role requires senior leadership experience in TMF and a strong background in FDA, GCP, and ICH guidelines, coordinating with executives and sponsors to deliver compliant TMF programs.