Day One Biopharmaceuticals

Compliance

• Develops, implements, and maintains quality management systems for drug safety and pharmacovigilance activities, including SOPs, guidelines, controlled documentation, and training programs.
• Oversees pharmacovigilance compliance activities, including audits, inspections, deviation management, CAPA (Corrective and Preventive Actions), and root cause analyses.
• Advises on pharmacovigilance quality, ensuring adherence to global regulations (FDA, EMA, ICH, GVP, MHRA) and industry standards.
• Defines, tracks, and reports key metrics and performance indices to measure the effectiveness of pharmacovigilance quality programs and training.
• Monitors and analyzes safety data to identify trends, potential risks, and areas for improvement; leads risk management and mitigation strategies.
• Designs and implements comprehensive training strategies for pharmacovigilance staff, cross-functional teams, and vendors, ensuring ongoing compliance and competency.
• Leads preparation for regulatory inspections and audits.
• Acts as the main point of contact for QA during audits, including response formulation.
• Leads corrective action plans related to drug safety and quality assurance.
• Identifies gaps in pharmacovigilance systems/processes and drives continuous improvement initiatives.
• Collaborates with internal and external stakeholders, including clinical, regulatory, and quality teams, to ensure integrated safety processes and documentation.
• Stays current with evolving global regulations and best practices in drug safety and quality management.
• Manages and mentors drug safety and quality staff; fosters a culture of continuous improvement and compliance.
• Collaborates with Safety Systems to manage and implement change control procedures.

Senior Director, Pharmacovigilance Quality and Compliance

Operations

• Oversee day-to-day office management, including lunch and snack programs, office supplies, mail and packages, equipment, kitchen, storage and shared spaces to ensure a safe, functional and well-organized work environment
• Manage relationships with building management, maintenance and external vendors to coordinate office maintenance, repairs, space planning and workplace improvement requests
• Support office moves, expansions, seating plans and workspace optimization
• Establish office operational and best practices procedures, and manage related communications
• Oversee and manage facilities budgets, including related facilities contracts and service agreements with external vendors
• Develop process efficiency and scalability as business needs evolve
• Lead workplace safety programs, including annual Safety Month, safety and emergency preparedness, safety protocols, emergency evacuation procedures, and ergonomic assessments
• Conduct periodic safety reviews to ensure compliance with workplace safety programs and guidelines
• Maintain documentation required for safety programs and building compliance
• Plan and execute virtual, onsite and offsite corporate events, including social and learning events, All Hands, celebrations and other employee engagement activities
• Manage event logistics, including catering, AV, space setup, vendor coordination and budget management
• Partner with key stakeholders on culture-building initiatives, swag programs, employee experience and recognition programs to foster connection and engagement to support our remote hybrid work model
• Partner with cross-functional stakeholders to facilitate seamless new hire onboarding experiences
• Partner with Corporate Communications to develop and maintain relevant employee communications related to policy rollouts and other internal programs
• Provide support for other People Team programs and initiatives, as needed

Facilities and Workplace Operations Manager

People Operations

• Serve as the senior HR advisor to the Head of R&D and his leadership team, partnering on strategy, org design, workforce planning, leadership development, and succession.
• Translate scientific and portfolio strategy into people and organizational plans that scale with rigor and flexibility.
• Coach senior leaders through complex decisions of growth, change, performance, and culture, grounded in sound judgment and business context.
• Act as a connective tissue between R&D and the broader enterprise, ensuring alignment without slowing momentum.
• Partner closely with the Chief People Officer to design and mature a robust internal communications capability appropriate for a growing public biotech.
• Advise executives on clear, authentic communication during moments of change, growth, and ambiguity.
• Help leaders in crafting a clear story about the direction of Day One and how each employee plays a role in the mission.
• Serve as a visible steward of Day One’s culture and leadership expectations.
• Embed inclusion and belonging into talent, rewards, leadership behaviors, and decision-making—not as a program, but as a way of working.
• Model executive-level partnership grounded in trust, discretion, and accountability.

Senior Director, Strategic People Business Partner

Learning and Development

• Reporting to the VP, People Business Partners, you will work across all levels of the organization, from executives, functional leaders, product teams, to intact teams, helping leaders move from functional excellence to enterprise effectiveness.
• This role designs and enables the systems, frameworks, and leadership behaviors that allow Day One to operate as a cohesive, decision-capable organization, especially as complexity increases across functions, product teams, and stages of development.
• Design and implement decision-making frameworks that improve clarity, accountability, and speed across the enterprise.
• Help leaders navigate complex trade-offs by introducing shared language, decision rights, and escalation paths.
• Build and evolve operating models that support cross-functional collaboration (e.g Product teams, sub-teams, MLR, etc).
• Facilitate leadership sessions, team resets, and cross-functional working sessions when alignment or clarity is needed.

Director, Organizational Development

Vice President

• Lead strategy creation and alignment of internal and external experts
• Hold primary accountability for the forward progress of Day One’s development programs
• Work closely with functional leaders and relevant sub-teams
• Communicate program strategy, progress, milestones, timelines
• Establish and maintain key external stakeholder relationships

Vice President, Product Team Leader

Director

• Develop and maintain precision medicine vision and strategy through cross-functional partnership with Leadership of Clinical Development, Translational Research, Regulatory Sciences, Clinical Pharmacology, and Commercial, as well as other Day One functions
• Design and implement hypothesis-driven strategies to deliver evidence of target engagement, mechanisms of action/resistance, patient selection/CDx strategies and other clinically-relevant biomarker endpoints to advance the Day One pipeline
• Provide technical, clinical and regulatory expertise in assay development and diagnostics (NGS, IHC, Immunoassays along with emerging biomarker technologies and platforms) across diverse stakeholders comprising leadership in Research and Development, Commercial, Regulatory Sciences, Medical Affairs, and Patient Advocacy, including but not limited to, training, education, and representation on behalf of our Translational and Precision Medicine-related events
• Effectively partner with Precision Medicine leaders to execute on the development of clinical biomarkers, assay development through companion diagnostics to maximize patient access to Day One drugs
• Manage external diagnostic partners, CROs, academic collaborators, and vendors to ensure high-quality biomarker and CDx deliverables.
• Leadership expertise in developing and maintaining precision medicine screening strategies across clinical programs, leveraging your extensive experience in testing report interpretation
• Author and review Precision Medicine related publications as well as appropriate sections in clinical study / regulatory documents (i.e. INDs, IBs, trial protocols/ops manuals, ICFs, IRB responses, HA Briefing Books, CSRs, etc.)
• Work closely with Business Development and Precision Medicine leaders to support candidate asset acquisition assessments through clinical biomarker and CDx considerations
• Develop and implement comprehensive clinical biomarker strategy across clinical programs
• Lead the strategic planning and execution of CDx development, including assay selection, analytical validation strategies, clinical validation plans, and alignment with regulatory and commercial partners.
• Help Day One remain a leader in oncology drug development across all ages
• Engaging, inspiring, and successfully communicating with employees of any level in the organization.
• Understanding and embracing one of our highest values: that the most precious asset is our team.
• Proactively contributing to company-building and process evolution as we grow

Director, Precision Medicine

QA Engineer

• Functions as program QA owner for ADC and biologics assets, establishing the QA strategy and quality plan across Phases 1–3.
• Provides interpretation of FDA/EMA/ICH biologics and ATMP guidance, ensuring development activities are compliant, risk-based, and phase-appropriate.
• Anticipates regulatory expectations and drives inspection readiness across internal teams and CDMOs.
• Guides teams on phase-specific requirements (e.g., specification tightening, method validation depth, stability expectations, comparability strategies).
• Provides strategic QA oversight for method qualification, validation, transfer, and ongoing performance assessment for biologics and ADC-specific assays (e.g., DAR, conjugation profile, potency).
• Ensures analytical control strategies are aligned with QbD principles and development phase expectations.
• Owns end-to-end QA oversight of drug substance, intermediates, payloads, linkers, conjugation steps, and drug product batches.
• Ensures batch record packages from CDMOs are complete, compliant, and meet internal quality standards before disposition.
• Provides high-level guidance on complex deviations and investigations, evaluating scientific adequacy, true root cause, and effectiveness of CAPAs.
• Advises teams on what is required vs. optional at each phase: Phase 1, Phase 2, Phase 3.
• Ensures risks, data gaps, and regulatory impacts are identified and communicated early.
• Serves as senior QA representative on CMC and Development Teams, driving quality risk assessments and program decision-making.
• Leads QA governance of CDMO relationships, oversees audit planning, evaluates vendor responses, and escalates systemic issues.

Associate Director, Quality Assurance – Biologics and ADC

• Identify, cultivate, and maintain professional relationships with national, regional, and emerging KOLs and other key stakeholders.
• Assess where customers are in their engagement and advocacy journey and deploy tactics to deepen engagement and advocacy.
• Identify and secure KOLs for key projects and initiatives.
• Conduct 1:1 and small-group engagements to strengthen advocacy and enhance understanding of the disease area and product data.
• Collaborate with the thought leader strategy lead and other cross-functional teams to develop/update KOL strategy and engagement plans.
• Gather and share actionable insights from KOL interactions to inform brand strategy and execution.
• Identify and monitor emerging trends, sentiment shifts, and competitive activity, ensuring timely communication to the broader commercial organization.
• Stay current on data readouts, congress presentations, and scientific developments to support informed KOL discussions.
• Translate national brand strategy into actionable regional marketing plans including key account strategy and plans that address regional opportunities and barriers.
• Lead regional cross-functional initiatives in collaboration with Sales, Medical Affairs, and other cross functional partners in a compliant manner.
• Partner with sales and medical leadership teams and field teams to ensure strategic alignment across KOLs, accounts and customer segments.
• Act as a collaborative, field-based marketing partner to Sales and Medical, supporting account access and relationship development, especially in hard-to-reach or strategically important accounts.
• Identify and facilitate educational and partnership opportunities with professional societies and centers of excellence.
• Lead compliant execution of regional speaker programs and P2P educational events.
• Provide ongoing coaching and feedback to ensure message consistency and speaker excellence.
• Partner with field teams to identify, vet, and contract qualified speakers based on regional needs.
• Collaborate with regional business directors to plan and execute programs aligned with educational priorities.
• Lead thought leader engagement planning and execution at key national and regional congresses.
• Coordinate on-site KOL meetings, non-CME educational events, and customer receptions in collaboration with cross-functional teams.
• Partner across Sales, Medical Affairs, and cross-functional teams to ensure coordinated and compliant external engagement.