Day One Biopharmaceuticals

Medical Director

• Provide medical and scientific expertise and oversight for clinical trials
• Act as the Medical Monitor for clinical trials, ensuring patient safety
• Engage in program-level activities, including authoring/reviewing safety and efficacy summaries, clinical overviews, and clinical sections of product labels
• Present study results to internal and external committees or advisory boards, as well as preparing data for presentation at international scientific meetings and publications
• Collaborate with the DAY301 Product Team Lead and lead the Clinical Development Sub-Team within the Product Team
• Provide oversight and leadership to the study/program clinical development team
• Ensure development of and/or adherence to safety review plans
• Perform and document regular review of individual subject safety data
• Interact with Regulatory Authorities and Internal Regulatory and QA Groups on a Study Level
• Assist in the preparation and delivery of clinical study reports and results for internal (corporate) and external (regulatory) purposes

Senior Medical Director, Clinical Development

Compliance

• Develop, implement and maintain global regulatory strategies across all phases of drug development from IND/CTA preparation through product approval and the post-marketing setting
• Further build the regulatory and quality functions, build, and maintain strong leadership capabilities at all levels within the team and support the professional development of team members
• Oversee U.S. / international submissions and strategic interactions with Health Authorities
• Oversee submission and maintenance of global regulatory filings
• Assure compliance with relevant regulations and guidelines
• Communicate with and manage consultants, CROs, and other vendors
• Develop regulatory strategies and submission plans to achieve submission milestones and marketing authorization in support of development timelines and corporate goals
• Oversee regulatory activities, including the preparation, review and submission of regulatory documents such as meeting requests, briefing documents, Health Authority responses, clinical trial / marketing applications, pediatric plans, product labeling
• Submission and life-cycle maintenance of US and international regulatory filings
• Oversee and have accountability for CMC Regulatory Submissions
• Perform other duties as required, interfacing with other departments, CROs and external vendors as needed
• Act as primary point of contact for external collaborations (e.g. ex-US markets)

Vice President, Regulatory Science

Program Manager

• Define the mission, operating model, tools and best PM practices across the R&D portfolio
• Lead through example by providing world class PM support to our flagship program, Ojemda
• Be a strategic and operational partner to the Ojemda PTL in all aspects of program planning and execution
• Develop and implement standardized project management frameworks (e.g. tools, processes, and behaviors) for programs from early to late development and through commercialization, such as risk management, communication plans, stage-gates and budget tracking
• Drive cross-functional alignment and operational excellence of all product teams. Critical cross-functional stakeholders are anticipated to include, for example:
• Chief of Staff to the Chief Executive Officer
• Corporate Finance (especially FP&A)
• Head, Strategy and Operations within Research and Development
• Chief Technical Officer (Head of CMC)
• Head of Development Operations
• Partner with Finance to align on budget planning, forecasting and resource allocation across the portfolio
• Partner with CMC to incorporate CMC deliverables into the product plan, developing scenarios and risk assessments as required
• Provide strategic leadership to the PMO and product teams to meet corporate objectives
• Identify and mitigate product and portfolio risks proactively, anticipating issues and implementing contingency strategies to ensure timelines and budgets are met
• Lead and mentor a growing team of program managers, fostering a culture of accountability, collaboration and continuous professional development
• Continuously assess and optimize project management tools and systems, incorporating lessons learned and evolving company needs
• Serve as a thought partner to senior leadership on program operational strategy, scenario planning and portfolio trade-offs
• On a by-program basis:
• Ensure the creation and maintenance of project/program(s) timelines and interdependencies within each product team, as well as appropriate stage-gates for investment
• Provide project coordination and communication in support of cross-functional product team(s) and all subteams
• Establish and maintain metrics to track projects and provide real-time reporting of project status
• Identify issues and risks and work with the team to develop mitigation strategies
• Coordinate and lead all aspects of internal product team meetings, including agenda drafting and documentation of key discussion points, decisions, and action items
• As the program advances, work with key stakeholders to ensure project management work for regulatory submissions such as INDs and global NDA/BLA/MAA of assets in partnership with regulatory operations

Senior Director – Head of Program Management

Director

• Lead the design, development, and implementation of phase-appropriate analytical methods for characterization, release, and stability testing of intermediates, APIs, and drug products.
• Define and execute analytical control strategies, identifying CQAs and establishing specifications across modalities (biologics, small molecules, ADCs).
• Oversee lifecycle management of analytical methods, ensuring compliance with ICH, FDA, and EMA standards.
• Drive continuous improvement and analytical innovation across programs.
• Provide technical oversight for global CDMOs and contract labs performing method development, validation, and GMP testing.
• Ensure analytical methods and specifications are scientifically sound, validated, and aligned with CMC and regulatory expectations.
• Support investigations, deviations, and CAPAs across internal and external quality systems.
• Partner with CMC, QA, Regulatory, and Process Development teams to ensure analytical strategies align with overall development and manufacturing objectives.
• Communicate quality risks and mitigation plans across functions and lifecycle stages.
• Lead the authoring and review of analytical sections in INDs, BLAs, NDAs, and other regulatory submissions.
• Serve as the analytical SME in health authority interactions and inspections.
• Maintain alignment with evolving regulatory and pharmacopeial standards (USP, EP, JP).

Senior Director, Analytical Development, Quality Control

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.