I am trained researcher with extensive technical and translational writing experience both in academia and industry. I excel at project management, research and written communication.

Annelise M. Roy

I am trained researcher with extensive technical and translational writing experience both in academia and industry. I excel at project management, research and written communication.

Available to hire

I am trained researcher with extensive technical and translational writing experience both in academia and industry. I excel at project management, research and written communication.

Experience Level

Language

English
Fluent

Work Experience

Associate Director of Clinical Research at StimLabs
October 1, 2024 - November 30, 2025
Provided strategic leadership for regulatory and market-facing clinical research programs, including post-market strategy, 510(k) clearance, reimbursement coverage, and product lifecycle objectives in a rapidly scaling medical device company. Managed end-to-end daily activities of clinical studies to support regulatory clearance and reimbursement, maintaining FDA, IRB, GCP, and SOP compliance. Drove clinical data strategy, including data collection, management, and basic statistical analyses; developed research databases and governance to enable executive decision-making, publications, and commercial activities. Ran multimillion-dollar budgets, including vendor budgets and variance reporting, and established risk-based plans with cross-functional teams. Served as liaison with CROs, oversaw site selection, startup activities, and vendor oversight. Stood up new clinical and quality-adjacent functions and contributed to post-market surveillance workflows.
R&D Manager at StimLabs
January 1, 2021 - November 30, 2024
Directed development of placental tissue-based products, including regulatory review and cross-functional planning to support 510(k) and BLA objectives. Built and mentored an agile, high-performing team of scientists and researchers across product ideation, translational science, technology transfer, IP development, and competitive differentiation. Established a cross-functional clinical core team for real-world evidence to support product reimbursement and market adoption. Led four product launches by coordinating R&D, Quality, Operations, and Commercial teams, and contributed to the first birth tissue-derived wound management product's regulatory pathway. Founded the company’s Training Academy for Operations technicians and helped establish a formal Program Management function to improve cross-functional planning.
Senior Scientist at StimLabs
December 1, 2018 - January 31, 2021
Developed five novel tissue and medical device products, innovating tissue processing techniques to advance regenerative medicine initiatives. Served as SME on new product concepts and development processes, providing scientific guidance for internal projects and external collaborations. Conducted in-depth biomedical research and contributed to patent applications, quality and SOPs, and cross-departmental project management systems to improve traceability and efficiency.
Scientist at StimLabs
September 1, 2017 - December 31, 2018
Designed and executed experiments for new product development and process optimization; conducted collaborative studies to generate data supporting product differentiation. Contributed to invention disclosures and initial patent documentation; authored SOPs governing manufacturing to ensure compliance and reproducibility; built departmental project management and documentation systems to improve data integrity and workflow efficiency.
Associate Scientist at StimLabs
January 1, 2016 - September 30, 2017
Designed and executed experiments to support new product development and process optimization; conducted collaborative studies to support product differentiation and marketing initiatives. Assisted in invention disclosures and initial patent applications; built and maintained inventory and laboratory management systems; developed lab safety, SOP, and MSDS workflows to ensure compliance.

Education

Master of Science, Biological Sciences at Auburn University
January 11, 2030 - January 1, 2015
Bachelor of Arts, Biology at Swarthmore College
January 11, 2030 - January 1, 2012

Qualifications

SOCRA Membership
January 11, 2030 - January 8, 2026
Good Clinical Practices (GCP) Certification
January 1, 2025 - January 8, 2026
Member, Technical Affairs Committee - The American Association of Tissue Banks
January 1, 2021 - January 8, 2026
Auburn University Master’s Thesis Award
January 1, 2015 - January 8, 2026
American Society of Mammalogists Research Grant
January 1, 2014 - January 8, 2026

Industry Experience

Healthcare, Life Sciences, Manufacturing, Professional Services, Other