Engineering · Full-time · Remote · Remote possible
Who We Are Cogent Biosciences is a publicly traded biotechnology company developing real solutions to treat genetically driven diseases. With a focus on rational drug discovery and development, we are leveraging validated biology to advance precision therapies designed to address the true underlying drivers of disease and provide real hope for patients. Cogent’s lead therapeutic candidate, bezuclastinib (CGT9486), is a precision kinase inhibitor designed to selectively and potently inhibit the KIT D816V mutation. This mutation is responsible for driving a rare and serious condition called Systemic Mastocytosis (SM), which can severely impact many different tissues and organs in the body. We are also studying CGT9486 to treat advanced gastrointestinal stromal tumors (GIST), which have a strong dependence on oncogenic KIT signaling. We are currently enrolling two Phase 2 clinical trials for patients with SM and a global Phase 3 trial for GIST patients.
Our Team https://cogent.culturehq.com
This is an exciting opportunity to join our growing Quality department. The Manager, Quality Assurance GCP provides quality oversight for the company’s clinical projects, primarily through the conduct of vendor audit activities as well as investigator site audits. Additionally, the position provides QA support and consulting to internal study teams, working closely with relevant functional areas. The position develops, plans, and executes audits to ensure compliance with regulatory standards and company policies and procedures. The ideal candidate must be comfortable working independently, managing interactions with and between team members, both internally and externally.
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