Gilead Sciences

Director

• Independently lead priority workstreams and contribute to U.S. Lymphoma Medical Affairs strategy planning and execution
• Serve as a strategic medical partner to Field Medical, Commercial, Market Access, HEOR/RWE, Global Medical Affairs, Clinical Development, Regulatory, Safety, and other cross-functional teams
• Translate clinical data, disease-area insights, and external stakeholder perspectives into medical strategy, field priorities, and evidence-generation opportunities
• Refine scientific communication platforms, core medical content, FAQs, slide decks, and field resources
• Co-lead advisory boards, expert engagement plans, congress activities, symposia, medical education initiatives, and stakeholder events
• Represent U.S. Medical Affairs in cross-functional forums, disease-area teams, and governance meetings
• Partner with Field Medical on training, scientific narratives, insight generation, and responsive medical resources
• Provide medical review and approval of promotional, educational, and scientific materials for accuracy, balance, and compliance
• Contribute to publication planning, evidence-generation strategy, investigator-sponsored research review, and real-world evidence initiatives
• Manage cross-functional project teams, timelines, deliverables, budgets, and agency partners
• Identify business and field medical needs, anticipate risks, remove barriers, and drive practical solutions
• Build relationships with internal stakeholders and external experts to support scientific exchange, insight generation, and medical education
• Maintain scientific integrity, ethics, regulatory compliance, and collaboration across Medical Affairs activities

Associate Director, Lymphoma, U.S. Medical Affairs

• Provide global Quality leadership for GMP facilities, utilities, and equipment across the company network
• Define and maintain enterprise policies, standards, and strategies with Facilities and Engineering
• Provide independent Quality review, approval, oversight, and risk-based guidance across facilities, utilities, and equipment lifecycles
• Ensure compliance with cGMPs, company policies, and regulatory requirements
• Lead network-wide harmonization and continuous improvement
• Establish, maintain, evaluate, and improve control strategies
• Serve as global Quality subject matter expert in governance forums
• Provide Quality oversight and approval for new process design and facility start-up
• Oversee significant investigations, CAPAs, and sharing of lessons learned
• Oversee regulatory submissions and inspections and govern observations and commitments through closure
• Analyze performance and reliability data to prioritize risks and guide decisions
• Build partnerships with Facilities, Engineering, Quality, Manufacturing, suppliers, and other stakeholders
• Define, implement, and maintain facilities, utilities, and equipment quality programs
• Build network capability through knowledge programs, communities of practice, and mentoring
• Communicate decisions, risks, and recommendations to senior leaders and stakeholders
• Create inclusion, develop talent, and empower teams

Director, Facilities & Equipment Quality Strategy – Technical Oversight Support

Operations

• Lead field force KPI development and performance reporting, including field-facing dashboards and reports
• Analyze sales performance and field execution data to identify trends, opportunities, and areas for improvement
• Collaborate with sales leadership to develop analysis for business opportunities across geographies
• Conduct analytics projects for field force targeting, call planning, sales force sizing, and account planning
• Work with brand teams to measure marketing tactic effectiveness
• Lead field force effectiveness initiatives with Sales, Marketing, Integrated Insights, and Commercial Learning & Development
• Lead territory optimization and realignment to balance workload and maximize business opportunity
• Generate on-time monthly and quarterly deliverables with rigorous data quality control
• Lead field incentive compensation planning and operations
• Coordinate with Sales, Marketing, Global Data & Digital Innovation, and other stakeholders on scope, requirements, and timelines
• Lead user testing, training, and adoption of reports and dashboards
• Recommend and drive continuous improvement and AI initiatives to enhance sales effectiveness and efficiency
• Create inclusion, develop talent, and empower teams as a people leader

Associate Director, Sales Analytics – Operations

• Provide global Quality leadership for GMP facilities, utilities, and equipment across the company network
• Define and maintain enterprise policies, standards, and strategies with Facilities and Engineering
• Provide independent Quality review and approval across facilities, utilities, and equipment lifecycles
• Ensure compliance with cGMPs, company policies, and regulatory requirements through risk-based oversight, escalation, and approval
• Lead network-wide harmonization and continuous improvement
• Establish, maintain, evaluate, and improve control strategies
• Serve as global Quality subject matter expert in governance forums
• Provide Quality oversight and approval for new process design and facility start-up
• Oversee significant investigations, corrective and preventive actions, and network-wide lessons learned
• Provide Quality oversight and approval for regulatory submissions and inspections
• Apply GMP requirements, standards, and best practices for facilities, utilities, and equipment
• Analyze performance and reliability data to prioritize risks and guide decisions
• Represent Quality in regulatory interactions
• Partner with Global Quality, Facilities, Engineering, Manufacturing, suppliers, and other stakeholders
• Build network capability through knowledge programs, communities of practice, and mentoring
• Provide leadership and guidance supporting quality, compliance, accountability, and continuous improvement

Medical Director

• Partner within the Strategy Team to execute required tasks and activities, deputizing when required
• Execute tactics such as advisory boards, publications, and training
• Provide vision and direction for the assigned disease area
• Drive development and execution of cross-functional product and disease strategy
• Partner with Global Medical Affairs teams including RWE, Scientific Communication, and Publications to provide input, direction, and review of materials
• Capture internal and external therapy-area insights and translate them into actionable activities
• Guide development and execution of disease strategy, medical Plans of Action, and cross-functional projects
• Participate in exchange with the medical community and maintain a thought leader network
• Collaborate compliantly with Clinical Research, Sales and Marketing, Market Access, and PVE
• Represent Global Medical Affairs to experts, medical professional groups, societies, regulatory groups, and at scientific meetings
• Report to the Head of Global Medical Lymphoma/Leukemia Strategy

Associate Director, Medical Affairs

• Partner within the Strategy Team to execute required tasks and activities, deputizing when required
• Execute tactics such as advisory boards, publications, and training
• Provide vision and direction for the assigned disease area
• Drive development and execution of cross-functional product and disease strategy
• Partner with Global Medical Affairs teams including RWE, Scientific Communication, and Publications to provide input, direction, and review of materials
• Capture internal and external insights on the assigned therapy area and translate them into actionable activities
• Provide guidance for development and execution of disease strategy, medical Plans of Action, and cross-functional projects
• Participate in exchange with the medical community and maintain a thought leader network
• Collaborate compliantly with Clinical Research, Sales and Marketing, Market Access, and PVE
• Represent Global Medical Affairs to experts, medical professional groups, societies, regulatory groups, and at national and international scientific meetings
• Report to the Head of Global Medical Lymphoma/Leukemia Strategy

Manager

• Drive end-to-end operational delivery of Phase II and III oncology trials
• Coordinate and supervise all aspects of clinical studies
• Assist the Clinical Program Manager in overall study management
• Provide input into study protocols, investigator brochures, case report forms, informed consents, final study reports, study plans, and presentations
• Maintain study timelines, documentation, and communications
• Contribute to study budgets, RFPs, and CRO/vendor selection
• Manage CROs, vendors, or functional service providers as needed
• Provide operational contact and oversight for site evaluation, initiation, close-out, and monitoring visits
• Oversee study sites/regions and review regulatory documents for compliance
• Ensure effectiveness of site budget and contract processes
• Train CROs, vendors, investigators, and study coordinators on study requirements as needed
• Coordinate data listing reviews and preparation of interim/final clinical study reports and appendices
• Resolve data discrepancies
• Develop tools and processes to optimize project efficiency and effectiveness
• Serve as a resource for clinical trials management expertise

Clinical Trials Manager

• Drive end-to-end operational delivery of Phase II and III oncology trials
• Coordinate and supervise all aspects of clinical studies
• Assist the Clinical Program Manager with overall study management
• Provide input into study protocols, investigator brochures, case report forms, informed consents, final study reports, study plans, and presentations
• Maintain study timelines, documentation, and communications
• Contribute to study budgets and RFP development
• Participate in CRO/vendor selection
• Manage CROs, vendors, or functional service providers as assigned
• Oversee site evaluation, initiation, close-out, and monitoring visits
• Provide oversight of study sites/regions and review regulatory documents for compliance
• Ensure effectiveness of site budget and contract processes
• Train CROs, vendors, investigators, and study coordinators on study requirements as needed
• Coordinate data listings and interim/final clinical study reports and appendices
• Resolve data discrepancies
• Develop tools and processes to optimize project efficiency and effectiveness
• Serve as a resource for clinical trials management expertise
• Examine functional issues from an organizational perspective under general supervision

Compliance

• Develop and implement regulatory product strategies
• Represent the regulatory function on cross-functional development teams
• Provide regulatory guidance and strategy, including identifying and assessing regulatory risks, mitigations, and contingencies
• Plan, prepare, and review submissions to FDA, EMA, and other national authorities for clinical trials and marketing applications, including IND, CTA, BLA, and MAA, throughout assigned project lifecycles
• Lead and oversee assigned project activities to ensure compliance with applicable FDA requirements
• Manage regulatory aspects of products and projects, including timelines and deliverables
• Ensure regulatory documents are accurate, complete, verifiable, and compliant with regulatory requirements
• Serve as US Regulatory Lead for assigned Regulatory Project Teams
• Monitor, analyze, and disseminate intelligence on regulatory matters affecting development programs
• Interpret and advise on regulations, directives, and guidance
• Prepare meeting requests and briefing documents, coordinate and prepare teams for authority meetings, and serve as primary liaison for day-to-day interactions
• Coordinate and prepare responses to regulatory authority information requests
• Train, manage, and mentor regulatory affairs personnel
• Engage externally in regulatory policy initiatives
• Perform other duties as assigned

Senior Manager, Regulatory Affairs

• Develop and implement regulatory product strategies
• Represent the regulatory function on cross-functional development teams
• Provide regulatory guidance and strategy, including identifying and assessing regulatory risks, mitigations, and contingencies
• Plan, prepare, and review submissions to FDA, EMA, and other national authorities for clinical trials and marketing applications, including IND, CTA, BLA, and MAA submissions
• Lead and oversee assigned project activities to ensure compliance with applicable FDA requirements
• Manage regulatory aspects of products and projects, including timelines and deliverables
• Ensure regulatory documents are accurate, complete, verifiable, and compliant with regulatory requirements
• Serve as US Regulatory Lead for assigned Regulatory Project Teams
• Monitor, analyze, and disseminate intelligence on regulatory matters affecting development programs
• Interpret and advise on regulations, directives, and guidance
• Prepare meeting requests and briefing documents, coordinate teams for health-authority meetings, and serve as primary liaison for day-to-day interactions
• Coordinate and prepare responses to regulatory-authority information requests
• Train, manage, and mentor regulatory affairs personnel
• Engage externally in regulatory policy initiatives
• Perform other duties as assigned

• Support preparation and submission of CMC regulatory filings, including INDs, CTAs, BLAs, MAAs, supplements, and variations
• Contribute to Module 3 (CMC) content development for cell therapy products and associated LVV and critical raw materials
• Assist in execution of global CMC regulatory strategies for cell therapy products and lentiviral vector manufacturing platforms
• Partner with Process Design, MSAT, Quality, Manufacturing, and Supply Chain teams on regulatory deliverables
• Support health authority interactions, including responses to information requests and meeting materials
• Assess change controls for regulatory impact and support lifecycle management activities
• Support manufacturing changes, comparability, and site updates for cell therapy and LVV manufacturing operations
• Contribute to inspection readiness activities and prepare supporting documentation
• Maintain accurate regulatory records and documentation related to LVV manufacturing, supply, compliance, and health authority commitments
• Identify and escalate risks and contribute to mitigation strategies
• Participate in continuous improvement and knowledge-sharing activities
• Create inclusion, develop talent, and empower teams as a people leader

Manager, Regulatory Affairs CMC

• Support preparation and submission of CMC regulatory filings, including INDs, CTAs, BLAs, MAAs, supplements, and variations
• Develop Module 3 (CMC) content aligned with global regulatory requirements for cell therapy products and associated LVV and critical raw materials
• Assist with execution of global CMC regulatory strategies under guidance of senior staff
• Partner with process development, manufacturing, analytical testing, comparability, and supply continuity teams to support regulatory deliverables
• Support health authority interactions, including responses to information requests and meeting materials
• Assess change controls for regulatory impact and support lifecycle management activities
• Support manufacturing changes, comparability, and site updates for cell therapy and LVV manufacturing operations
• Contribute to inspection readiness activities and prepare supporting documentation
• Maintain accurate regulatory records and documentation
• Identify and escalate risks and contribute to mitigation strategies
• Participate in continuous improvement and knowledge-sharing activities
• Create inclusion, develop talent, and empower teams as a people leader

Strategy

• Serve as a trusted advisor to the General Manager
• Synthesize complex information into executive-ready insights, recommendations, decision materials, and Board-level communications
• Translate strategy into priorities, roadmaps, performance measures, operating rhythms, and actionable plans
• Drive strategic initiatives from development through execution
• Lead annual strategic, financial, resource, and headcount planning
• Coordinate the consolidated Plan of Action
• Design and manage leadership governance, planning cycles, quarterly business reviews, and accountability mechanisms
• Coordinate enterprise and functional initiatives across US Commercial
• Align ownership, resources, dependencies, risks, sequencing, and measures of success
• Represent US Commercial in enterprise and global planning forums
• Track business performance and commitments, identify barriers, and drive mitigation, course correction, productivity, and process improvements
• Lead planning and execution for major GM-sponsored meetings, including National and Midyear Meetings
• Coordinate cross-functional readiness for anticipated US product launches
• Advance organizational and leadership effectiveness
• Develop communications for leadership meetings, business reviews, all-hands presentations, and internal and external audiences
• Serve on the Kite Commercial BS&O Forum

Director, Business Strategy and Operations

Data Management

• Support development and maintenance of global clinical data standards and operational data mappings
• Apply CDISC standards in standards development
• Develop and maintain global library objects, including eCRFs, edit checks, and dynamics
• Assist in regular releases of the Global Library Volume (GLV)
• Contribute to CRF Completion Guidelines development
• Work with Medidata RAVE, TrialGrid, Azure, Smartsheet, SharePoint, and Veeva Vault to develop, maintain, and release the GLV
• Support consistency and adherence to Kite standards across programs and portfolios
• Support Standards Core Committee and Standards Governance Committee activities
• Prepare materials, document decisions, and follow up on action items
• Partner with functional stakeholders to support standards adoption
• Identify and suggest process improvements and support standards-related initiatives
• Ensure compliance with regulatory requirements, industry standards, GCP/ICH guidelines, and internal procedures
• Provide study support during initial EDC builds, including standards implementation, change management, issue resolution, impact analysis, solution proposals, and escalation
• Execute assigned global library build and maintenance activities
• Perform quality checks on standards implementation
• Document standards release activities

Senior Associate, Clinical Data Standards Management

• Support Kite’s commercialization efforts for CAR-T
• Inform the lifecycle management process
• Collaborate with key stakeholders to guide product and disease area strategy
• Provide an objective and detailed understanding of current and future markets, product performance, customers and competitors
• Generate foundational market understanding within the Cell Therapy area through market research and forecasting activities
• Design, build, maintain, and track robust, actionable, evidence-based forecasting models
• Produce analogues, formulate assumptions, and define forecast opportunities and risks
• Conduct forecast scenario analysis to support cross-functional decisions
• Provide guidance and input for short-term demand planning
• Synthesize market dynamics to identify performance drivers and develop communications materials for marketing and sales decisions
• Lead qualitative and quantitative market research studies with physicians, patients, and payers
• Integrate market research, competitive intelligence, and secondary analytics into actionable insights
• Manage vendors, research methodology, project alignment, execution, and reporting
• Partner with stakeholder groups to support strategic and tactical decision-making
• Create inclusion, develop talent, and empower teams as a people leader

Associate Director, Lymphoma, U.S. Medical Affairs

Director, Facilities & Equipment Quality Strategy – Technical Oversight Support

Associate Director, Sales Analytics – Operations

Director, Facilities & Equipment Quality Strategy – Technical Oversight Support

Associate Director, Medical Affairs

Associate Director, Medical Affairs

Clinical Trials Manager

Clinical Trials Manager

Senior Manager, Regulatory Affairs

Senior Manager, Regulatory Affairs

Manager, Regulatory Affairs CMC

Manager, Regulatory Affairs CMC

Director, Business Strategy and Operations

Senior Associate, Clinical Data Standards Management

Senior Manager, Global Insights, Analytics