Kura Oncology, Inc.

Medical Director

• Serve as subject matter expert in preparing clinical regulatory documents through all phases of clinical research
• Provide guidance on document strategy for complex regulatory dossiers, including IND and NDA/BLA filings
• Represent medical writing in cross-functional team meetings
• Collaborate with clinical research, clinical operations, data management, biostatistics, regulatory affairs, and medical affairs teams to deliver high-quality documents on time
• Adhere to ICH-E3 guidelines, federal regulations, and company SOPs
• Develop, improve, and maintain medical writing work practice documents, SOPs, and document templates
• Oversee external vendors, including contract writers, QC reviewers, and document formatters
• Maintain current knowledge of industry trends and best practices for medical writing
• Plan and manage document timelines
• Perform other duties as assigned

Director, Medical & Regulatory Writing

IT Support

• Oversee implementation, configuration, deployment, and lifecycle management of enterprise applications, platforms, and business systems related to the Commercial organization
• Configure and customize applications to meet evolving business requirements
• Manage and maintain SharePoint sites and implement platform changes
• Coordinate system upgrades, patches, and maintenance
• Support integrations between enterprise systems and third-party solutions
• Align technology capabilities with business strategy and operational priorities as an IT Business Partner
• Support strategic planning and technology roadmap development
• Translate organizational objectives and operational challenges into scalable technology solutions
• Identify opportunities for digital enablement, automation, and process optimization
• Facilitate project scoping, requirements gathering, and solution design
• Develop user requirements, SOPs, and operational processes
• Plan and execute projects, monitor progress, and communicate status to leadership
• Coordinate testing, validation, and implementation activities
• Provide functional and technical application support and troubleshoot system issues
• Develop and deliver training, documentation, and best-practice guidance
• Manage system security, user access, roles, and permissions
• Ensure data integrity and compliance with company policies, SOX, GxP, and regulatory requirements
• Support system documentation, validation, and audit readiness
• Manage application vendors, escalations, and service levels
• Evaluate emerging technologies and participate in innovation initiatives

Director, Medical & Regulatory Writing

Applications Administrator – IT Business Partner