Eikon Therapeutics
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Jobs at Eikon Therapeutics
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The Associate Director, GCP Auditing will lead the Clinical Quality Assurance audit program, ensure compliance with GCP guidelines, conduct various audits, provide expert regulatory guidance, review study documents, and develop training programs. The role requires strong leadership and communication skills with a focus on maintaining high quality in clinical trials.
The Manager, TMF Operations ensures the quality and accuracy of the Trial Master File (TMF) for clinical trials, collaborating with study teams, managing TMF documentation, performing audits, and ensuring compliance with regulatory standards. This role also involves training team members and supporting inspection readiness. Strong attention to detail and communication skills are essential.
The Senior Manager will lead cross-functional teams in the planning and execution of drug development projects, manage timelines, budgets, and regulatory compliance, and ensure collaboration among stakeholders. Responsibilities include reporting progress, facilitating meetings, and addressing project risks.
The Senior Associate for Study Start-Up will enhance operational efficiency in clinical trial execution, collaborating with various teams to manage study planning, site qualification, and compliance with established protocols. Key responsibilities include ensuring timely delivery of clinical trials and supporting feasibility and initiation visits.
The Senior Counsel at Eikon Therapeutics will manage the legal department's contracts function and provide counsel on various legal matters including privacy regulations, employment law, corporate governance, and healthcare compliance. The role involves collaborating with leadership and legal teams to support the company's strategic initiatives while overseeing a contracts team and managing outside counsel.
The Associate Director, Drug Product oversees drug product development and manufacturing, ensuring compliance with regulatory standards, while leading cross-functional teams to enhance the company's product pipeline from early clinical stages to commercial production.