Gilead Sciences

General

• Represent Gilead products and services to a defined customer base in the Charleston, SC territory
• Generate and grow sales by achieving or exceeding sales targets within the assigned geographic area
• Manage healthcare-provider accounts through in-person representation, face-to-face meetings, and strategic partnerships
• Establish relationships with healthcare providers and deliver disease-awareness information, clinical updates, and healthcare education
• Distill complex clinical concepts into understandable messages for diverse audiences
• Build and execute a territory business plan aligned with customer needs and sales goals
• Monitor sales progress and adjust strategies to meet or exceed targets
• Maintain expertise in Gilead products, competitive products, and the therapeutic area
• Promote appropriate use of Gilead products in accordance with Corporate, PhRMA, and OIG guidelines
• Partner with field reimbursement managers, medical scientists, and other field team members to support product access, acquisition, administration, and operations
• Collaborate with healthcare organizations and partner companies, including co-promotion efforts
• Uphold compliance standards, ethical behavior, regulatory requirements, and company policies
• Report adverse events to Gilead's Drug Safety and Public Health department
• Report call activity and customer information, submit expenses, and manage the territory budget
• Stay current on industry trends and therapeutic-area developments
• Work autonomously while exceeding performance standards
• Contribute to Gilead's Inclusion & Diversity efforts

Senior Prevention Specialist, HIV

Director

• Define and oversee the clinical operational data and analytics strategy for clinical systems including Veeva, Salesforce, Medidata, and custom applications
• Provide strategic leadership across concurrent projects and teams
• Lead and develop a high-performing organization, including direct people leaders
• Recruit, grow, and retain diverse talent; set goals and coach employees
• Shape short- and long-range Clinical Systems strategies and infrastructure plans
• Partner with business stakeholders and IT leadership on technical strategy and roadmaps
• Lead solution design and oversee major programs and projects
• Ensure on-time, high-quality, within-budget technical roadmap delivery
• Serve as a technical and data strategy spokesperson
• Oversee scalable data architectures, pipelines, APIs, and ETL processes
• Partner with Validation and Quality teams on testing, process optimization, system enhancements, and GxP compliance
• Optimize R&D applications and clinical systems to improve efficiency, cycle times, and performance
• Oversee end-to-end SDLC project deliverables
• Safeguard data integrity, audit readiness, and compliance
• Create program-level budgets and resource plans
• Drive policy adherence, continuous improvement, and operational excellence

Director, R&D Information Systems

• Develop and execute an integrated communications and advocacy strategy for Gilead Patient Solutions
• Serve as public affairs partner to GPS leadership and strategic thought partner to the Executive Director, Intercontinental Public Affairs
• Lead strategies supporting patient-centered access to innovation and public health priorities
• Translate insights across markets, functions, stakeholders, and external environments into coordinated public affairs strategies
• Advise senior leaders and regional cross-functional leadership teams on complex internal and external matters
• Partner with Public Affairs, Patient Advocacy, Government Affairs, Value & Access, Corporate Communications, Commercial, Medical, and other functions
• Lead external communications strategy and ensure message discipline across the enterprise, regions, and markets
• Create compliant communications explaining Gilead’s commitments, partnerships, access initiatives, and public health impact
• Build proactive storytelling opportunities, executive visibility, thought leadership, and reputation-building initiatives
• Prepare senior leaders for media interviews, conferences, panels, NGO meetings, and stakeholder forums
• Develop engagement strategies with global NGOs, patient organizations, advocacy coalitions, and external stakeholders
• Develop and sustain relationships with public health, patient support, healthcare delivery, and community health organizations
• Co-create education, engagement, and capacity-building initiatives with external partners
• Identify and manage global and regional issues and establish governance, protocols, and response frameworks
• Monitor risk and sentiment across geographies and embed reputation management into program design
• Draft and guide external statements, press releases, Q&A documents, holding statements, leadership messages, briefing materials, and reactive communications
• Integrate GPS priorities into enterprise narratives and employee engagement efforts
• Develop internal messages, talking points, employee updates, FAQs, briefings, presentations, and toolkits
• Enable leaders and managers to activate communications and advocacy strategies locally
• Define objectives, KPIs, and leading indicators across programs
• Build dashboards using qualitative and quantitative insights
• Lead cross-functional governance and oversee agency and external partner performance
• Manage agency partners, external consultants, budgets, and resources
• Create inclusion, develop talent, and empower teams as a people leader

Senior Director, Patient Solutions Public Affairs

• Develop and execute an integrated communications and advocacy strategy for Gilead Patient Solutions
• Advance company priorities, support sustainable access to innovation for patients, and strengthen Gilead’s reputation across diverse countries
• Serve as a trusted deputy and strategic thought partner to the Executive Director, Intercontinental Public Affairs
• Shape priorities across the GPS region and connect insights across functions and geographies
• Lead public affairs strategies supporting patient-centered access to innovation and public health priorities
• Translate emerging themes and insights into coordinated public affairs strategies and practical action
• Counsel senior leaders and regional cross-functional leadership teams on complex internal and external matters
• Partner with Public Affairs, Patient Advocacy, Government Affairs, Value & Access, Corporate Communications, Commercial, Medical, and other functions
• Lead external communications strategy and create compliant communications about commitments, partnerships, access initiatives, and public health impact
• Build proactive storytelling opportunities, executive visibility, thought leadership, and reputation-building initiatives
• Prepare senior leaders for media interviews, conferences, panels, NGO meetings, and stakeholder forums
• Develop and sustain relationships with global NGOs, patient organizations, advocacy coalitions, and other stakeholders
• Co-create education, engagement, and capacity-building initiatives with external partners
• Identify and manage global and regional issues and establish governance, protocols, and response frameworks
• Draft and guide external statements, press releases, Q&A documents, holding statements, leadership messages, briefing materials, and reactive communications
• Integrate GPS priorities into enterprise narratives and employee engagement efforts
• Develop internal messages, talking points, employee updates, FAQs, briefings, leadership presentations, and toolkits
• Define objectives, KPIs, and leading indicators for advocacy, NGO engagement, and communications programs
• Build and apply qualitative and quantitative insight dashboards for continuous improvement
• Lead cross-functional governance and oversee agency and external partner performance
• Manage agency partners, external consultants, budgets, and resources with fiscal discipline
• Create inclusion, develop talent, and empower teams as a people leader

Senior Director, Patient Solutions – Public Affairs

Manager

• Provide scientific and strategic leadership for pharmacovigilance activities supporting investigational and marketed products
• Serve as lead author for complex aggregate safety reports, including PSURs, PBRERs, and DSURs
• Synthesize global safety data and clinical context
• Author and review safety documents supporting regulatory submissions and lifecycle management
• Lead safety reviews, including search strategy design, data evaluation methodologies, and scientific interpretation of safety data
• Review individual case safety reports to identify and assess potential safety signals
• Prepare and lead responses to safety-related requests from global health authorities
• Support product labeling, including CCDS, USPI, SmPC, and Investigator’s Brochure
• Serve as Pharmacovigilance Science Safety Lead for products in development
• Partner with Clinical, Regulatory, Medical Affairs, and other stakeholders
• Provide safety content for clinical protocols, clinical study reports, informed consent forms, and other development and post-marketing documents
• Ensure compliance with global regulations and internal procedures
• Support audits and inspections and contribute to inspection readiness activities
• Create inclusion, develop talent, and empower teams as a people leader

Senior Manager, Kite Safety, Pharmacovigilance

Data Management

• Oversee all aspects of clinical data management studies from start-up to close-out for Kite’s clinical development programs
• Work closely with Biostatistics, Programming, Clinical Operations, Safety, and Regulatory teams
• Collaborate on project deliverables and timelines for clinical data collection, quality checking, and reporting
• Handle multiple studies complex in scope and volume
• Lead studies and projects without supervision oversight
• Ensure completeness, accuracy, and consistency of clinical data and data structure
• Lead preparation and design of eCRFs
• Review study protocols and lead or assist in planning and implementing data management portions of clinical studies
• Interact with site coordinators, investigators, and field clinical staff to collect data and resolve queries
• Use reports to track study progress and ensure timeliness and quality expectations
• Prepare and manage data management timelines
• Provide CDM expertise for external vendor data coordination, collection, and cleaning
• Manage CDM deliverables with internal and external cross-functional teams
• Review clinical data on an ongoing basis
• Support vendor processes including data entry, data quality checking, data transfer, and reporting
• Create or support Data Transfer Plans and external data documentation
• Manage and coordinate external data deliverables
• Coordinate query management, report delivery, study timelines, and database snapshots for analysis including Safety Review
• Ensure adherence to standard business processes within CDM systems and regulatory compliance
• Participate in clinical data management process design and implementation
• Serve as a point of contact for the study management team
• Facilitate meetings and presentations
• Delegate tasks to applicable staff members
• Identify, communicate, and escalate project-level issues involving processes, timelines, resourcing, and performance

Senior Clinical Data Management Associate

• Support Kite’s strategy for representativeness and inclusion in clinical trials
• Build and nurture community and advocacy relationships
• Build awareness internally and externally and drive health literacy
• Design diversity into programs and studies
• Enable clinical trial patient participation and improve participant outcomes
• Design and implement digital engagement campaigns using email marketing, digital content, webinars, and targeted outreach
• Develop and execute patient recruitment and enrollment strategies across clinical trials
• Design and manage multi-channel digital campaigns across social media, search, email, websites, and outreach initiatives
• Partner with Clinical Operations, Patient Engagement, Site Engagement, Medical Affairs, Public Affairs, and external vendors
• Monitor and analyze recruitment performance, conversion rates, enrollment trends, and return on investment
• Identify and implement innovative digital recruitment and enrollment solutions
• Serve as the digital marketing and patient enrollment subject matter expert
• Establish best practices, standard processes, and scalable approaches supporting Kite’s long-term Trial Equity goals
• Create inclusion, develop talent, and empower teams as a people leader

Manager, Trial Equity and Optimization

• Support Kite’s strategy for representativeness and inclusion in clinical trials
• Build and nurture community and advocacy relationships
• Build awareness internally and externally and drive health literacy
• Design diversity into programs and studies
• Enable clinical trial patient participation and improve participant outcomes
• Design and implement digital engagement campaigns using email marketing, digital content, webinars, and targeted outreach
• Develop and execute patient recruitment and enrollment strategies across clinical trials
• Design and manage multi-channel digital campaigns across social media, search, email, websites, and outreach initiatives
• Partner with Clinical Operations, Patient Engagement, Site Engagement, Medical Affairs, Public Affairs, and external vendors
• Monitor and analyze recruitment metrics, conversion rates, enrollment trends, and return on investment
• Identify and implement innovative, scalable, data-driven recruitment and enrollment solutions
• Establish digital marketing and patient enrollment best practices, standard processes, and scalable approaches
• Create inclusion, develop talent, and empower teams as a people leader

• Oversee all aspects of clinical data management studies from start-up to close-out for Kite’s clinical development programs
• Work closely with Biostatistics, Programming, Clinical Operations, Safety, and Regulatory teams
• Report to the Senior Manager, Clinical Data Management
• Collaborate to meet project deliverables and timelines for clinical data collection, quality checking, and reporting
• Handle multiple studies complex in scope and volume
• Lead studies and projects without supervision oversight
• Ensure completeness, accuracy, and consistency of clinical data and data structures
• Lead preparation and design of eCRFs
• Review study protocols and lead or assist in planning and implementing data management portions of clinical studies
• Interact with site coordinators, investigators, and field clinical staff to collect data and resolve queries
• Use reports to track study progress and ensure timeliness and quality expectations
• Prepare and manage data management timelines
• Provide CDM expertise for external vendor data coordination, collection, and cleaning
• Manage CDM deliverables with internal and external cross-functional teams
• Review clinical data on an ongoing basis to ensure quality
• Assist with vendor implementation of routine clinical data management processes, including data entry, data quality checking, data transfer, and reporting
• Create or support Data Transfer Plans and other external data documentation
• Manage and coordinate external data deliverables
• Coordinate query management, report delivery, study timelines, and database snapshots for analysis, including Safety Review
• Ensure adherence to standard business processes within CDM systems and compliance with regulatory bodies
• Participate in the design and implementation of clinical data management processes
• Serve as a point of contact for the study management team
• Facilitate meetings and presentations
• Delegate tasks to applicable staff members
• Identify, communicate, and escalate project-level issues involving processes, timelines, resourcing, and performance

Medical Director

• Lead a portfolio of clinical trial programs in cell therapy clinical development
• Oversee the design, conduct, evaluation, close-out, and reporting of clinical trials
• Lead and direct clinical development strategies, including Target Product Profiles and Clinical Development Plans
• Develop, implement, and oversee strategies for assigned molecules/products with cross-functional leaders and teams
• Represent assigned products in cross-functional steering and governance committees
• Lead or oversee clinical trial protocol design and clinical study reporting
• Lead written and oral communications with health authorities
• Provide or oversee medical monitoring, including eligibility assessment, toxicity management, and drug safety surveillance
• Lead or oversee clinical development components of regulatory documents, investigator brochures, and development plans
• Oversee ongoing data collection, internal analysis, data listings, summary tables, study results, and scientific presentations
• Present scientific information at conferences and investigator meetings
• Lead authorship of scientific publications where applicable
• Assist in clinical evaluation of business development opportunities
• Develop thought leader and external relationships to guide clinical development strategies
• Ensure adherence to GCP, ICH guidelines, internal SOPs, and industry standards
• Typically manage a team of direct reports
• Create inclusion, develop talent, and empower teams

Executive Director, Clinical Development – MD

• Provide scientific and strategic leadership for pharmacovigilance activities supporting investigational and marketed products
• Serve as a senior pharmacovigilance science expert
• Lead complex safety analyses, regulatory deliverables, and cross-functional safety strategy execution
• Serve as lead author for complex aggregate safety reports, including PSURs, PBRERs, and DSURs
• Synthesize global safety data and clinical context
• Author and review high-impact safety documents supporting regulatory submissions and lifecycle management
• Lead safety reviews, including search strategy design, data evaluation methodologies, and scientific interpretation of individual and aggregate safety data
• Review individual case safety reports to identify and assess potential safety signals and support signal detection and management
• Prepare and lead responses to safety-related requests from global health authorities
• Support product labeling, including CCDS, USPI, SmPC, and Investigator’s Brochure
• Serve as Pharmacovigilance Science Safety Lead for products in development
• Partner with Clinical, Regulatory, Medical Affairs, and other stakeholders
• Provide safety content for clinical protocols, clinical study reports, informed consent forms, and other development and post-marketing documents
• Ensure compliance with global regulations and internal procedures
• Support audits and inspections and contribute to inspection readiness activities
• Create inclusion, develop talent, and empower teams as a people leader

Senior Manager, Kite Safety and Pharmacovigilance

Compliance

• 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 global CMC regulatory strategies for cell therapy products and lentiviral vector manufacturing platforms
• 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 for manufacturing facilities
• Maintain accurate regulatory records and documentation related to LVV manufacturing, supply, regulatory compliance, and health authority commitments
• Identify and escalate risks and contribute to mitigation strategies concerning global regulatory expectations
• Participate in continuous improvement and knowledge-sharing activities
• Support assigned regulatory programs under guidance and contribute to timely submissions and responses
• Support development and execution of regulatory strategies for LVV manufacturing processes used in commercial and late-stage clinical cell therapy programs
• Contribute to regulatory assessments and risk management for manufacturing changes, facility transfers, process improvements, and capacity expansion initiatives
• 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
• Contribute to Module 3 CMC content development for cell therapy products, lentiviral vectors, and critical raw materials
• Assist in executing global CMC regulatory strategies under senior staff guidance
• Partner with process development, manufacturing, analytical testing, comparability, and supply continuity teams
• Support health authority interactions, information-request responses, 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 operations
• Contribute to inspection readiness activities and prepare supporting facility documentation
• Maintain accurate regulatory records and documentation
• Identify and escalate risks and contribute to mitigation strategies
• Participate in continuous improvement and knowledge-sharing initiatives
• Contribute to timely regulatory submissions, responses, assessments, and risk management for LVV manufacturing changes, facility transfers, process improvements, and capacity expansions
• Create inclusion, develop talent, and empower teams as a people leader

Clinical Operations

• Provide input into strategic and operational short- and long-range therapeutic or functional area plans
• Provide leadership, guidance, oversight and therapeutic expertise for clinical trials
• Manage strategic, operational and financial oversight of assigned programs
• Develop, implement, manage and complete clinical trials within designated budgets and timelines
• Set the strategic vision for assigned clinical trials and programs
• Assess, onboard and manage CROs and other vendors, including RFPs and selection processes
• Contribute to the strategic implementation of Clinical Development Programs as a member of the Clinical Sub-Team and potentially the Global Development Team
• Lead cross-functional Study Management Teams and influence stakeholders
• Analyze project status and issues and implement risk mitigation strategies
• Anticipate complex obstacles and implement solutions
• Address national and international regulations, guidelines and investigator interactions
• Keep stakeholders informed about project status and issues
• Track, oversee and communicate program status using available tools
• Contribute leadership input to study-related documentation, including study protocols
• Oversee Clinical Operations activities conducted by the affiliate to support clinical trials
• Initiate, author or contribute to SOP development, implementation and training
• Ensure team work complies with established practices, policies, processes and regulatory requirements
• Hire, develop and retain diverse talent; set expectations; coach direct reports on performance, development and career interests

Associate Director, Clinical Operations

• Provide input into strategic and operational short- and long-range therapeutic or functional area plans
• Provide leadership, guidance, oversight and therapeutic expertise for clinical trials
• Provide strategic, operational and financial oversight of assigned programs
• Develop, implement, manage and complete clinical trials within designated budgets and timelines
• Set the strategic vision for assigned clinical trials and programs
• Assess, onboard and manage CROs and other vendors, including RFPs and selection processes
• Contribute to Clinical Development Programs as a member of the Clinical Sub-Team and potentially the Global Development Team
• Lead cross-functional Study Management Teams and influence stakeholders
• Analyze project status and issues and implement risk mitigation strategies
• Anticipate obstacles and implement solutions to achieve project goals
• Address national and international regulations, guidelines and investigator interactions
• Communicate project status and issues to stakeholders
• Track, oversee and communicate program status using available tools
• Contribute leadership input to study-related documentation, including protocols
• Manage affiliate Clinical Operations activities required by local regulations or usual practice
• Initiate, author or contribute to SOP development, implementation and training
• Ensure team work complies with established practices, policies, processes and regulatory requirements
• Hire, develop and retain diverse talent; set expectations; coach direct reports and support development of people leaders