The Director of HR Operations at Eikon Therapeutics will oversee HR operations including payroll, compliance, and benefits, drive process improvements, and lead the HR Operations team. Responsibilities include managing the transition to a new HRMS and aligning HR operations with business objectives.

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, 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.

As a Senior Medical Writer at Eikon Therapeutics, you will author and edit regulatory documents related to clinical studies, collaborate with various teams for high-quality documentation, manage document lifecycles, and ensure compliance with regulatory standards, while continuously improving writing processes.

The Manager of HR Operations at Eikon Therapeutics will oversee HR processes including payroll, benefits, immigration support, and compliance. This role focuses on enhancing operational efficiency, delivering effective HR service, updating policies, and implementing new HRMS systems, while collaborating with various departments to align with organizational goals.

The Senior Director of Medical Writing at Eikon Therapeutics leads a team to transform complex scientific information into clear documents for clinical trials and regulatory compliance. Responsibilities include overseeing document creation, ensuring regulatory adherence, conducting literature reviews, and fostering team growth through leadership and mentorship.

The Associate Director, Medical Writing will lead the authoring and editing of regulatory documents for clinical studies. Responsibilities include managing document lifecycles, improving writing processes, interpreting scientific data, and ensuring adherence to company and regulatory guidelines. The role requires strong project management and communication skills, as well as the ability to work independently and in a collaborative environment.

As the Director of Medical Writing, you will lead a team in creating and overseeing various medical and scientific documents, ensuring clarity and compliance with regulatory standards. You'll also interpret complex data, collaborate with cross-functional teams, and contribute to strategic planning.

The Manager, Regulatory Submission Publisher is responsible for overseeing the regulatory submissions publishing process, ensuring compliance with industry standards. Duties include managing document workflows, collaborating with cross-functional teams, and maintaining knowledge of submission guidelines to support regulatory inspections and audits.

As a Senior Manager in Regulatory Affairs, you'll ensure compliance with FDA and international regulations for biopharmaceuticals, guide product development strategies, manage submissions like IND and NDA, and collaborate across teams to integrate regulatory considerations into product development.

The Senior Director, Regulatory Affairs will lead regulatory strategy and compliance efforts, ensuring alignment with regulations and standards while collaborating with cross-functional teams. Responsibilities include developing regulatory strategies, managing submissions, overseeing compliance with manufacturing and clinical practices, and addressing regulatory risks.

The Manager, Regulatory CMC will lead the development and execution of CMC strategies for drug products, oversee regulatory submissions, and manage documentation processes. This role requires collaboration with cross-functional teams, technical oversight, and ensuring compliance with regulatory standards. Strong leadership and project management skills are essential for success in this position.

The Director, Trial Master File Operations leads TMF operations for clinical trials, ensuring compliance, managing teams and vendors, developing processes, and overseeing quality control. They collaborate with cross-functional teams and serve as the TMF inspection lead, focusing on performance improvements and regulatory adherence.

The Executive Medical Director will oversee drug safety data assessment from clinical trials and reports, ensuring compliance with regulations. Responsibilities include leading safety reports, managing safety signals, and interacting with health authorities. The role requires strong leadership skills and a deep understanding of pharmacovigilance regulations to maintain high patient safety standards.

The Senior Manager, Biostatistics will lead statistical efforts in designing and analyzing clinical trials and experimental studies. They will collaborate with interdisciplinary teams, develop statistical analysis plans, and perform advanced statistical analyses. This role involves providing statistical expertise for regulatory submissions and mentoring team members while staying updated with biostatistics trends.