Entrada Therapeutics

Serve as the unblinded operational lead for clinical studies, managing vendor coordination and drug supply workflows. Ensure strict separation between blinded and unblinded teams while maintaining study integrity and regulatory compliance.

The Associate Director will support global regulatory strategy for clinical-stage programs and manage health authority submissions including IND, CTA, and EU-CTR. They will collaborate with cross-functional teams and external stakeholders to ensure compliance and advance the development of genetic medicines.

This role will lead and manage late-stage drug substance development for pipeline programs, supporting clinical and commercial batch development and ensuring manufacturing validation parameters are met. Responsibilities include facilitating batch execution and release through technical review, partnering with Quality teams on late-stage activities, and acting as a person-in-plant for critical manufacturing execution.