Medical Director – Seattle Vaccine Trials Unit (VTU)

Responsibilities

• Provide onsite medical oversight for all clinical trials and observational studies conducted within the VTU.
• Ensure participant safety, protocol compliance, and adherence to Good Clinical Practice (GCP), FDA, National Institutes of Health, and institutional requirements.
• Serve as the medical authority for eligibility determinations, adverse event and reactogenicity assessment, and protocol deviation management.
• Serve as the contact physician for research study participants and their clinical care providers.
• Partner with site leadership to ensure efficient, compliant, and high-quality clinical trial operations.
• Oversee clinical workflows, resource allocation, and continuous performance improvement initiatives.
• Collaborate with regulatory, pharmacy, laboratory, and data teams to ensure seamless study execution.
• Support readiness for protocol monitoring, and audits and inspections from federal, industry sponsors, and regulatory authorities.
• Work closely with the VTU Principal Investigator, Site PIs, and collaborating clinical and research investigators to implement scientific priorities.
• Contribute to protocol development, feasibility assessments, and study design.
• Potential participation in leadership activities within NIH-funded research networks (e.g., HVTN), including protocol teams lead, committees, working groups and publication preparation.
• Serve as a liaison with external partners, including academic collaborators, industry sponsors (e.g., IAVI, VIR, Janssen, Merck, Gilead), and public health stakeholders.

Qualifications

• MD or DO (or equivalent) with board certification in Infectious Diseases or a related field.
• Active or eligible for Washington State medical licensure.
• Demonstrated experience in clinical research and clinical trials (preferably Phase I–III).
• Experience supervising clinical teams.
• Deep knowledge of GCP, regulatory environments, and human subjects research.
• Experience with HIV research and/or vaccine trials.
• Prior involvement in NIH-funded clinical research networks (e.g., HVTN, DAIDS).
• Experience serving as PI, sub-investigator, or medical monitor.
• Track record of collaboration across academic, industry, and public sector partners.
• Strong interest in advancing health equity and inclusive research practices.