Open to opportunities

Tristan Roberts

@tristanroberts

Founder & CEO at Dog Years Inc., who designed an FDA-reviewed canine gene therapy study and built its wearable-data analysis pipeline.

United States

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What I'm looking for

I'm ready for a Clinical Trial Associate role, bringing experience coordinating a sponsor’s IRB-approved Phase 1 clinical study, preparing IRB submissions, and supporting trial participants and operations.

At Dog Years Inc., I designed and ran a preclinical canine pilot of a follistatin gene therapy for osteoarthritis, tracking mobility with smart-collar posture data and video gait scoring. I also designed a 60-animal, three-arm, multi-dose proof-of-concept study that FDA CVM reviewed with no objections.

At Minicircle, I coordinated the sponsor’s IRB-approved Phase 1 human clinical study of a follistatin plasmid gene therapy. I wrote nearly all of its IRB submission documents and served as the point of contact for participants through day-to-day trial operations.

I built the wearable-data analysis pipeline in Python and coordinated protocols, dosing rationale, and regulatory filings with veterinary, CRO, and manufacturing partners. My work also includes developing experiment SOPs and maintaining Safety Data Sheets.

Experience

Work history, roles, and key accomplishments

Current

Founder & CEO

Current

Dog Years Inc.

Jan 2024 - Present (2 years 9 months)

Designed and ran a preclinical canine pilot of a follistatin gene therapy for osteoarthritis, tracking mobility with smart-collar data. Designed a 60-animal proof-of-concept study reviewed by FDA CVM, and coordinated cross-functional work with veterinary, CRO, and manufacturing partners.

Preclinical Study Design Gene Therapy FDA CVM Submissions Cross functional Coordination Python Data Analysis Wearable Data Monitoring Statistics

Research Coordinator & Operations

Minicircle

Jul 2021 - Aug 2023 (2 years 1 month)

Coordinated the sponsor's IRB-approved Phase 1 human clinical study of a follistatin plasmid gene therapy. Wrote study documentation for IRB approval, served as participant point of contact, tracked investigational product, and developed SOPs.