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Strand Therapeutics, a clinical-stage biotechnology company pioneering programmable mRNA therapeutics, is seeking a Senior Vice President of Regulatory Sciences to build and lead its regulatory function from the ground up. Reporting to the President and Co-Founder, this executive will shape the company's engagement with domestic and global health authorities and directly influence the pace of bringing transformative therapies to patients.
Key responsibilities include building and leading the Regulatory Sciences function—encompassing Global Strategy, CMC (Chemistry, Manufacturing, and Controls), Operations, and vendor management—with emphasis on scalability, speed, and scientific depth. The SVP will own and evolve regulatory strategy for clinical and preclinical programs using data-driven approaches aligned with Strand's Signal Stack platform technology. This role serves as the company's primary voice in all regulatory interactions, preparing and leading meetings with FDA (CBER), TGA, EMA, and other agencies.
The SVP will shape early development decisions by partnering closely with R&D, Clinical, and Technical Operations teams to ensure data packages and study designs are regulatory-ready. The role drives innovation in regulatory science to support accelerated development paths and novel mechanisms, particularly for next-generation mRNA and gene/cell therapies. As a trusted strategic partner to senior leadership, the SVP contributes to portfolio prioritization, risk management, and long-range development planning while fostering a collaborative culture that balances strategic thinking with agility and pragmatism.
Strand's pipeline focuses on oncology and autoimmune disease, with STX-001 (an intratumorally delivered self-replicating RNA expressing IL-12) demonstrating preliminary evidence of systemic immune activation and anti-tumor activity. STX-003, designed for tumor-targeted expression, is expected to enter the clinic in mid-2026. The company was founded by MIT synthetic biology pioneers, has raised over $250 million, and is headquartered in Boston.
