Director, Development Business Operations

Summary

Join our team as a Director, Development Business Operations (Contract) at Day One Biopharmaceuticals. This role is accountable for the strategic implementation of business operations services to support delivery of Phase I-IV essential functions and safety capabilities.

Requirements

• Bachelor's degree preferably in a scientific field
• At least 10 years of project management experience, which includes cross functional and team leadership
• Considered SME for SOPs, Inspection Readiness, process innovation initiatives, and advancement of Development Operations as an organization
• Demonstrated strong leadership competencies in a matrix environment
• Proactive problem solver, excellent communication and team management skills
• Experience in managing multiple and complex projects in a fast-paced environment
• Participation/experience with regulatory audits and inspections is preferred
• Excellent communication skills and management skills with attention to detail
• Strong understanding of ICH, GCP and relevant regulatory requirements
• Proficiency with Box, Smartsheet’s, Microsoft Outlook, Excel, Word, PowerPoint

Responsibilities

• Oversight of the business operations process and innovation implementation efforts for Development Operations
• Manages Dev Ops documents and standards process
• Leads key process document creation, update or obsoletion of Dev ops documents
• Connects key CAPA outputs cross-functionally and ensures their impact is disseminated and incorporated into Development Operations processes
• Ensures that requested updates to dev ops process are tracked, managed, and closed
• Organize leadership meetings and ensure the tracking and closure of action items
• Demonstrate accountability and leadership in managing external partners and vendor performance
• Build and foster cross functional relationships to promote and support effective communication of processes, changes, and gaps
• Critical thinking and analytical skills and ability to make high level decisions in cross-functional and global environments
• Ability to review, analyze, interpret, and present complex data to a high standard
• Leads onboarding of all new employees or contractors, including notification to functions of onboard date, training plan assignment, equipment, and system access request
• Leads offboarding of all employees and contractors to ensure continuity of information
• Ensure all CVs are current and stored for access in audits and inspections
• Monitors adherence to individual training plans and ensures compliance or escalation to Sr. leadership when an FTE or contractor is not in compliance
• May have direct reports
• Key contributor to proactively identifying process gaps across Development Operations and proposes solutions to address and implement the gaps
• Develop, refine, and monitor policies and procedures to meet quality and compliance standards
• Owns the training process for Development Operations
• Leadership support for the Dev Ops SME Council
• Develops roles for training across Development Operations
• Attends the Document and Standards meeting as the Development Operations representative
• Shepherds controlled documents through QA process aligning on approved and effective dates
• Implements and maintains a controlled documents change tracker for requests to Development Operations Policy, SOPs, WIs and Guides
• Initiates controlled document templates for new Policy, SOP, WIs and Guides Collaborates with the Sr. Director of Development Operations on changes to strategy, cross-functional process changes, regulatory changes to ensure controlled documents have an impact assessment and are sent to the SME Council for update and closure
• Develops the Box structure for document management across Development Operations
• Owns the psiXchange process for all clinical trials and EAP, IST, and CUP trials
• May provide support for meeting management and minutes for key department meetings
• Owns Safety training (GUI-001) and trains vendors where required
• Review Study level documents including Study Management Plans, Study Safety Summaries and SAE Reconciliation Plans