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First-in-class therapies for rare autoimmune diseases
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Lead Phase I clinical strategy and execution
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Equity + flexible hybrid working
We are partnering with a venture-backed biotech startup based in Cambridge, MA, focused on developing first-in-class small molecule therapies for rare autoimmune diseases. With fewer than 100 employees, the company is advancing its lead candidate into Phase I clinical trials. They are seeking a Director of Clinical Operations to drive early-stage clinical strategy and execution as they prepare for critical first-in-human studies.
Reporting to the VP of Clinical Development, the Director of Clinical Operations will oversee all aspects of clinical trial planning, site selection, CRO management, and study execution. This is a hands-on role suited for an operational leader eager to build clinical frameworks in a high-growth environment. You'll collaborate closely with regulatory, medical, and biometrics teams to ensure trials are conducted efficiently and meet all regulatory standards.
The ideal candidate will have 8+ years of clinical operations experience in biotech or pharma, with prior leadership of early-phase studies, particularly Phase I. A strong background in rare disease or immunology will be highly regarded. Experience managing CROs, working cross-functionally, and operating effectively in fast-paced, resource-lean environments is essential. This role requires a hands-on leader who can thrive in ambiguity and help build scalable clinical processes from scratch.
In return, the company offers a competitive startup salary along with a significant equity package. You’ll have the opportunity to build and scale the clinical function with visibility to executive leadership and investors. The company supports flexible working arrangements, with a Cambridge-based HQ and a hybrid in-office schedule designed to support collaboration while maintaining work-life balance.