Executive Director, Clinical Operations

Sandra Sinclair, BSBA, MHA/ED, RN

Sandra is Lantern Pharma's Executive Director of Clinical Operations, leading the oversight, execution, and operational strategy of Lantern’s clinical programs, including clinical trial development, study execution, vendor and CRO oversight, regulatory support, quality systems, and budget and contract management across the portfolio.

As Executive Director of Clinical Operations, Sandra is responsible for the oversight, execution, and operational strategy of Lantern’s clinical programs, including clinical trial development, study execution, vendor and CRO oversight, regulatory support, quality systems, and budget and contract management across the portfolio.

Prior to joining Lantern, Sandra brings more than 30 years of experience in clinical operations, clinical trial management, and regulatory compliance across academic cancer centers, biotechnology companies, and large oncology research networks. Most recently, she served as Director and Senior Director of Clinical Operations at Alaunos Therapeutics, SAB Biotherapeutics, and Formation Biologics, where she led clinical operations teams supporting Phase 1 and Phase 2 programs, established and scaled clinical infrastructure, developed and implemented SOPs, managed study closeouts and regulatory reporting, and worked closely with CMOs, Medical Monitors, CROs, and investigational sites to ensure high-quality, cost-effective trial execution. Throughout her career, Sandra has played a key role in vendor selection and oversight, contract and budget negotiations, IND-related activities, Investigator’s Brochure updates, DSUR submissions, and clinical trial registry reporting, while driving operational efficiency through process improvement and compliant eTMF systems.

Earlier in her career, Sandra held senior clinical operations, compliance, and trial management roles at US Oncology, MD Anderson Cancer Center, and the University of Hawaii Cancer Center, where she oversaw multi-site oncology trials, led auditing and monitoring programs, supported NCI-affiliated research networks, and ensured adherence to GCP, ICH, GLP, and GMP standards. She has also contributed to clinical research education through publications and podium presentations at national and international conferences.

Sandra holds a Bachelor of Science in Business Administration with a minor in Education, a Master of Health Administration, and an Associate Degree in Nursing. She is Lean Six Sigma Green Belt trained, bringing a strong focus on operational rigor, quality, and continuous improvement to Lantern’s clinical development efforts.

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