Day One Biopharmaceuticals

Learning and Development

• Maintains a GMP-compliant document management system, to include oversight and auditing of the system.
• Plans and executes multiple tasks to ensure controlled documents are managed per procedures and applicable regulations.
• Manages manual electronic signature process .
• Processes cross functional documents, both electronically and hard copy as needed.
• Assists with the set-up and changes in systems, ensuring processes are followed.
• Manages Document Control and Training processes, providing training to personnel as needed.
• Backup for the Complaints and Change Control processes, providing training to personnel as needed.
• Administrator for Document Management System and Training Management System.
• Provides support on various other projects as necessary, ensuring appropriate Document Control is maintained.
• Provides support during inspection activities.
• Other duties as required and necessary to ensure the success of the organization.

Document Control and Training Specialist

Vice President

• Serve as the subject matter expert (SME) on global drug safety requirements in all phases of drug development and post-market support, providing leadership in the transition from a clinical stage company into an organization encompassing global post-market drug safety and risk management.
• Represent the Pharmacovigilance and Patient Safety Department across all Day One Bio programs.
• Lead and oversee the fundamental activities of Safety Operations including continuous safety data collection and compliant regulatory reporting.
• Lead and oversee Pharmacovigilance signal detection, risk management activities and risk mitigation strategies throughout the lifecycle of Day One Bio’s products.
• Provide oversight and management of pharmacovigilance agreements (PVAs) and relationship management with Development Partners.
• Ensure ongoing evaluation of the overall safety profile for all of Day One Bio's investigational products and regular presentation of safety data in cross-departmental safety review meetings.
• Identify matters that need escalation upper leadership via internal safety governance processes.
• In coordination with Regulatory Affairs, plan, and support safety input into regulatory submissions including registration product applications and product labeling for the safety sections of the assigned products and indications (e.g., CCSI, USPI).
• Represent the company at Safety meetings and lead responses to and/or resolution of regulatory safety enquiries from regulatory agencies and health authorities.
• Standing member and Deputy Chair of the Safety Review Board for Safety Governance.
• Member of Senior Leadership Team (SLT).
• Provide drug safety expertise and review for the accuracy and quality of all safety sections in pre- and post-approval documents with timely communication of recommendations and/or actions to internal and external stakeholders.
• Support both Clinical Development, Clinical Operations, and Medical Affairs teams with respect to safety related issues as required.
• Participate in planning, review and approval of clinical trial safety documents and aggregate safety reports, (e.g., DSURs, PADERs) including content of clinical protocols and Investigator’s Brochures, annual reports, final study reports and other documents as needed.
• Provide input and review of responses to regulatory agency questions with regard to safety and pharmacovigilance activities.
• Assess global PV requirements for resources, equipment, and systems to maximize efficiency.
• Ensure the thorough collection and reporting of existing safety data from all sources, to allow accurate risk characterization overtime, and maintenance of a positive benefit risk balance for Day One Bio’s product.
• Develop overall risk management plans, pharmacovigilance strategies, and risk minimization activities.
• Ensure robust integrity and maintenance of a global safety database to ensure compliance of the safety system for approved products and products in the Day One Bio portfolio.
• Lead optimization of the current signal detection system to ensure signal identification, evaluation, and validation through product lifecycle and with consideration for global partnership PVA compliance.
• Represent Global Drug Safety at regulatory authority meetings, and at external conferences and conventions.
• Lead cross-functional and cross-departmental interactions with clinical development, medical affairs, regulatory affairs, and commercial groups.
• Collaborate as necessary with business development team to contribute to any due diligence activities.
• Interact and represent safety and pharmacovigilance purposes, representing Company with selected Corporate Partners.
• Hire, develop, and mentor the Pharmacovigilance and Patient Safety team.
• Assess and align the organization to meet the goals of the long-range business plan.

Vice President, Pharmacovigilance and Patient Safety

Operations

• Act as strategic thought partner to VP, Medical Affairs, supporting leadership of Medical Affairs Leadership Team (MA-LT) operations and cross-functional alignment.
• Lead Medical Affairs strategic and tactical planning cycles (annual functional plan, Integrated Evidence Generation Plan (IEGP), publications, scientific communications plan, etc.).
• Drive strategic initiatives to evolve Medical Affairs (e.g., Med Affairs 2.0, upskilling field teams, process optimization).
• Integrate insights from internal and external sources into strategic recommendations and portfolio decision-making.
• Oversee Medical Affairs budget and resource allocation in partnership with Finance, ensuring alignment with Program Team (PT) and corporate goals.
• Develop and manage functional dashboards, Key Performance Indicators (KPIs), and operational metrics to measure impact and enable informed decision-making.
• Ensure inspection readiness and adherence to regulatory/compliance standards across Medical Affairs deliverables.
• Provide operational leadership for Investigator Sponsored Trials (ISTs), Compassionate Use Program (CUP)/ Expanded Access Program (EAP), Continuing Medical Education (CME) grants, congress operations, and (Key Opinion Leader) KOL engagement.
• Manage vendor relationships, contracting operations, Fair Market Value (FMV) processes, and Needs Assessment Form (NAF) navigation.
• Oversee functional financial operations (bills, tracking, vendor oversight).
• Ensure systems, tools, and shared repositories are well-maintained and consistently utilized.
• Coordinate internal Medical Affairs meetings, logistics for congresses, and KOL engagement scheduling.
• Support execution, documentation, and reporting for ISTs, CUP, and grants/sponsorships.
• Share best practices across Medical Affairs to improve efficiency and standardization.

Director, Medical Affairs Strategy and Operations

• Advance first- or best-in-class medicines for childhood and adult diseases; accelerate targeted treatments at Day One.
• Serve as strategic advisor and operational leader on R&D Leadership Team, reporting to Head of R&D.
• Translate vision into action, coordinate across functions, and create structures and processes to enable R&D effectiveness.
• Ensure budget and resource accountability partnering with Department Heads, Finance, and People team.
• Own cross-department and cross-functional initiatives to drive operational excellence, optimize resource use, and oversee organizational change.
• Lead planning and execution of Board, portfolio management, and Executive Leadership governance meetings.
• Establish and oversee governance forums and manage operational metrics, reporting, and dashboards.
• Integrate R&D functions with broader stakeholders and streamline leadership communications.
• Build and lead a small strategy and operations team; mentor and develop talent and champion accountability and collaboration.
• Role can be fully remote but hybrid in Brisbane, CA is preferred.

Document Control and Training Specialist

Vice President, Pharmacovigilance and Patient Safety

Director, Medical Affairs Strategy and Operations

Senior Director, R&D Strategy and Operations