Gilead Sciences

Manager

• Establish tools which showcase end-to-end data lineage and impact assessments for standard objects from data collection through analysis and reporting.
• Collaborates with Clinical Data Engineering/Macros, CDS Systems & IT, and various cross-functional teams on testing and implementing technology solutions for standards implementation, automation, or governance management.​
• Oversees system operations for various platforms (in-house and/or vendor systems), that may include user access management, technical implementation and system usage.
• Develops workflows, tools, and reports to facilitate the integration of Rawplus standards (a data normalization layer) between data collection and SDTM.
• Assists in the brainstorming, testing, and documentation of tools which automate various components of statistical analysis (e.g. tables, figures, and listings, and SDTM tabulation domains, and ADaM analysis datasets).
• Stays informed of emerging technologies that can be adopted by the Data Standards organization to further enhance the implementation, efficiency, and usage of the Gilead clinical data standards.
• Pioneer and be engaged in initiatives which accelerate the cleanliness and data review tasks associated and/or dependent within Gilead’s standards library.
• Demonstrates understanding of CDISC guidance documents and implementation guides, as well as FDA guidance and other regulations while keeping abreast of industry trends in data mapping, data management, standards compliance methodologies, etc.
• Champions Digital Data Flow principles to accelerate automation, reduce manual effort, and digitize clinical trial workflows.

Senior Manager, Technical SME Standards

Learning and Development

• Lead the strategy, design, and delivery of knowledge- and skill-based learning solutions that enable success across the US Liver business, including disease state education, product training, onboarding, launch readiness, and advanced selling capabilities for field teams and managers
• Lead, coach, and develop a high-performing team in support of US Commercial and CL+D priorities, fostering a collaborative, accountable, and growth-oriented environment
• Provide strong people leadership across coaching, performance management, talent development, and succession planning for the US Liver learning team
• Demonstrate strong communication, facilitation, critical thinking, and decision-making skills, with the ability to operate effectively in a complex, matrixed environment
• Influence across functions and levels to build alignment, drive decisions, and ensure learning priorities support business strategy and field execution
• Partner with cross-functional stakeholders, subject matter experts, and commercial leaders to assess learning needs, identify capability gaps, and develop integrated training plans and materials that address evolving business priorities
• Collaborate closely with Marketing, Sales Leadership, Commercial Operations, Medical, Legal, Regulatory, and Business Conduct partners to ensure learning solutions are aligned, compliant, and effective
• Align training strategy to the broader commercial learning plan while balancing near-term execution needs with long-term capability building for the US Liver organization
• Apply adult learning principles and modern instructional design practices to create engaging, practical, and durable learning experiences that reinforce commercial strategy
• Leverage AI-enabled learning approaches, tools, and content development practices to improve personalization, accelerate deployment, increase learner engagement, and strengthen measurement of training effectiveness
• Hire, lead, and develop talent within the learning organization, with a focus on building strong capability, succession depth, and long-term organizational effectiveness
• Bring experience across multiple learning modalities, including instructor-led, virtual instructor-led, digital, and self-directed web-based learning
• Evaluate and apply emerging technologies, including AI, to modernize learning strategy, streamline content development, and enhance field capability building
• Define clear learning objectives, success measures, and performance outcomes for training programs and the team responsible for delivering them
• Oversee the development of training that supports onboarding, national meetings, manager meetings, product and skills sustainment, and other ongoing capability-building needs throughout the year
• Incorporate motivating, creative, and interactive learning strategies that maximize engagement, knowledge retention, and practical application in the field
• Lead projects from concept through execution, ensuring learning deliverables are high quality, on time, within scope, and aligned to business needs
• Communicate effectively in written, verbal, and visual formats with audiences ranging from field teams to senior leaders
• Continuously identify opportunities to improve learning strategy, delivery, and operational efficiency through innovation, experimentation, and best practice adoption
• Use sales performance metrics, learner feedback, and business insights to assess training impact and inform ongoing program design
• Manage agency and vendor relationships for content design and development, ensuring high-quality deliverables, strong partnership, and effective budget stewardship
• Manage budgets effectively in a headquarters-based commercial environment, balancing quality, impact, and operational discipline
• Bring a growth mindset and a strong orientation toward innovation, with the ability to identify opportunity in complexity and lead change effectively

Director, Commercial Learning and Development – US Liver

• leading the design and execution of oncology learning strategies across the US commercial organization
• partner with cross-functional stakeholders to translate business priorities into effective capability-building plans
• oversee the development of compliant, scalable, and impactful learning solutions across multiple modalities
• drive cross-functional alignment across Sales, Marketing, Market Access, Medical, and other teams to ensure the learning agenda supports business priorities

Director, Commercial Learning and Development

Director

• Partner on the development and execution of the above-brand oncology narrative
• Contribute to and help execute thought leadership strategies
• Collaborate closely with cross-functional stakeholders across Commercial, Medical, R&D, Government Affairs, and Patient Advocacy
• Support global product communications within the oncology portfolio
• Work in close partnership with the Senior Director of Product Communications for Oncology
• Identify opportunities to connect corporate, franchise, and product narratives

Associate Director, Public Affairs

• Provide Statistical leadership to Virology clinical trials: developing trial design options and providing high quality decision support.
• Statistical lead for a specific Virology molecule/indication in Health Authority interactions and maintain an accountability thread to TA head
• Works collaboratively with Statistical Programming, Biostatistics, Clinical Research, Clinical Data Management, Global Drug Safety, Regulatory and Project Management management/staff to meet project deliverables and timelines for statistical data analysis and reporting.
• Uses knowledge of Regulatory requirements regarding statistical principles to ensure the company meets its Regulatory, scientific, and business objectives.
• Collaborates with study investigators, outside experts, and internal colleagues to present and publish trial results and statistical analyses within and outside of the company.
• Negotiates project timelines given constraints, works with senior management and Human Resources to identify long-term staffing plans, provides career development opportunities to staff, and participates in strategic risk assessment based on statistical analyses or principles.

Director, Biostatistics – Virology

• Serve as an internal point-of-contact and trade strategy subject matter expert for Senior Leadership and key internal partners/stakeholders
• Stay abreast of key new trends, including identification of market disruptors
• Spearhead new product channel & distribution strategies
• Lead RFP development and vendor selection process for new service needs
• Identify appropriate portfolio and product specific service metrics and KPIs
• Develop Mature Product channel strategy
• Lead strategic insights generation via primary research and data analytics
• Collaborate with cross-functional partners/ stakeholders
• Attend outside meetings or conferences, as appropriate
• Work closely with Auditing, Regulatory, Legal and other partners/stakeholders
• Leverage appropriate Standard Operating Procedures (SOPs)

Director, Market Access – Trade Strategy

• Serve as an internal point-of-contact and trade strategy subject matter expert for Senior Leadership and key internal partners/stakeholders
• Stay abreast of key new trends, including identification of market disruptors and new channel segment needs/capabilities
• Spearhead new product channel & distribution strategies, and modifications based on ongoing market dynamics and evolving access paradigms
• Lead RFP development and vendor selection process for new service needs
• Identify appropriate portfolio and product specific service metrics and KPIs in alignment with Trade Account Teams
• Develop Mature Product channel strategy and work with Trade Account, Contracts, Operations and Regulatory for new and discontinued NDC management
• Lead strategic insights generation via primary research and data analytics to inform long-term strategic plans
• Collaborate with cross-functional partners to ensure key channel/distribution trends are incorporated into 3-year strategic planning
• Attend outside meetings or conferences to monitor competitive landscape and distribution trends
• Work closely with Auditing, Regulatory, and Legal to ensure fully compliant practices

• Lead HIV clinical development strategy and execution across treatment and cure programs
• Oversee study design, execution, data interpretation, and benefit-risk assessment
• Provide scientific and regulatory leadership for key development deliverables and interactions
• Collaborate across key functions and influence senior stakeholders in a matrixed environment

Executive Director, Clinical Development, MD

Procurement

• Manage onboarding of new vendors and suppliers in coordination with Legal and Procurement
• Manage end-to-end purchase order activities including creating orders, invoicing and reconciling issues
• Maintain positive relationship with internal customers and external vendors
• Monitor order status, triage customer inquiries, and proactively address delays or discrepancies to assist with order completion
• Prioritize multiple procurement activities and deadlines in a fast‑paced environment, ensuring timely execution
• Partner with Legal, Procurement, Accounting and PDM Finance to support contracting, purchase orders (PO) workflows and timely payment
• Support continuous improvement efforts by identifying routine operational issues and recommending improvements to enhance efficiency and reduce cycle times
• Maintain accurate supplier and PO records
• Contribute to the development and maintenance of procurement dashboards and metrics, providing visibility into spend, cycle times and vendor performance
• Serve as subject matter expert on procurement systems and PO workflows and provide training and guidance to cross-functional partners as needed
• Ensure compliance with Gilead policies, procurement and financial controls, data integrity standards, and confidentiality requirements

Vendor Management Specialist

Customer Support

• The Senior Director, Head of US Customer Experience and Patient Services reports to the Executive Director, Head of US Market Access (USMAx) and is responsible for the strategy, enablement, tactical execution, and performance of all of Kite’s US customer experience, patient access, and reimbursement support services
• Lead Kite’s US Case Management team and is responsible for the Patient Navigator team in partnership with AssistRx
• Partner closely with all relevant cross-functional stakeholders to assess potential need for a field reimbursement team and potentially build out and lead this team
• Collaborate with the Customer Experience team, Quality Assurance, Supply Chain Logistics, and other cross-functional partners to ensure optimal patient access and fulfillment of cell therapy for all eligible patients
• Develop and manage SOPs for Patient Services Team to provide superior patient assistance services, enhance efficiency of team members’ roles, improve efficient call handling and improve external perceptions
• Responsible for the continued development, maintenance, and performance of KiteKonnect.com and all relevant and connected tools and resources
• Develop call center metrics to measure the teams’ successes and performance
• Serve as an internal/external point-of-contact for all relevant business issues related to the Kite Konnect Hub, its patient support programs, and distribution for all cell therapies
• Collaborate with all commercial functions including Account Management, Marketing, Market Access and Customer Engagement to facilitate solutions for account and patient related issues
• Work closely with the Finance team to track costs and forecast operational expenses
• Lead presentations and develops material for internal training of the Market Access Director teams

Senior Director, US Customer Experience and Patient Services

Clinical Operations

• Manage a team of direct and potentially indirect reports.
• Oversee and be responsible for the successful execution of studies and/or multiple studies within a program or multiple programs, including financial responsibility.
• Responsible for the resource management of studies, including ongoing assessment of resource needs and optimal deployment of resources to support a fluid ‘One Ops’ workforce.
• Participate and engage in Clinical Operations and/or cross-functional organizational change initiatives.
• Act as the business process owner (BPO) and/or serve as a subject matter expert for Clinical Operations processes.
• Encourage an innovative mindset by championing new ideas and initiatives and incorporating best practices, external benchmarking and standardization across Clinical Operations.
• Hire, develop and retain diverse top talent on the team.
• Set clear goals for the team and individuals direct reports.
• Coach direct reports on their performance, development and career interests.
• Provide input into strategic and operational plans as appropriate, including supporting alignment and communications to other team members upon implementation.
• Act as team leader and builder; providing guidance and oversight for the successful management of all aspects of clinical trials within designated program budgets and timelines.
• Lead cross-functional Study Management Teams (SMTs) and influence all relevant stakeholders.
• Partner with cross-functional teams to manage, adjust and revise project timelines and budgets as needed.
• Communicate project status and issues and ensure project team goals are met in alignment with project decisions.
• Escalate issues as needed.
• Participate in the development of all study-related documentation, including study protocols.
• Participate in the selection and management of contract research organizations (CROs) / vendors, including development of requests for proposals (RFPs).

Clinical Program Manager

Compliance

• Responsible for preparing moderately complex regulatory submissions requiring interactions with departments outside of Regulatory Affairs CMC for investigational and commercial products
• Supports operational and life cycle management of regulatory CMC submissions in support of global commercial and clinical programs
• Identify CMC risk areas and suggest alternative scenarios and course of action
• Act as Regulatory CMC representative on cross-functional project teams
• Ensure that CMC-specific registered technical details are updated and maintained
• Manage Regulatory CMC commitments made to Health Authorities
• Support Annual Product Review or Vector Product Review for all products
• Present project status updates and strategic approaches to moderately complex programs

Senior Regulatory Affairs Associate, CMC

• Support biostatistical analysis and reporting, document review and data inclusion for NDA submissions of assigned studies
• Collaborate with cross-functional partners to meet clinical development project deliverables and timelines
• Provide statistical consultation on clinical development plans, clinical trial design, and clinical study endpoints
• Calculate sample size
• Author statistical analysis plans
• Provide biostatistical input into clinical development documentation, scientific publications, and presentations, and regulatory filings
• Contribute to short- and long-range Biostatistics strategies, plans, and infrastructure development that transcend multiple areas and teams across Biostatistics

Manager, Biostatistics

Marketing

• possess a high level of clinical and customer knowledge across lymphoma and multiple myeloma
• engage and influence health care professionals to help build educational platforms, generate insights
• inform the execution of current and future brand and disease-state strategies
• identify, profile, cultivate and maintain long-term partnerships with National OLs/Regional OLs/Emerging leaders within the Hematology community
• develop regional OL strategies and communicate those plans with cross-functional partners
• interact with OLs to solicit insights and develop advocacy aligned to commercial and marketing strategy
• engage in on-label conversations on topics such as disease diagnosis & treatment, referral dynamics
• plan and execute OL interactions and executive encounters at local, regional and national conferences
• work closely and collaboratively with cross-functional partners (e.g. sales, marketing)

Director, Regional Marketing – South Central

• Manage and develop an auditing team, including work planning and prioritization, performance monitoring, coaching, feedback, and formal performance reviews.
• Foster a culture of quality, accountability, and continuous improvement within the audit program.
• Serve as a member of the Quality Compliance & Audits Leadership Team helping to define strategy, deliver on business goals, and collaborate with other cross-functional teams across Gilead and Kite.
• Establish and execute a risk‑based annual audit plan.
• Monitor regulatory requirements, enforcement trends, and inspection intelligence; assess potential impacts to Gilead’s manufacturing and supply network; and proactively incorporate these insights into risk‑based audit planning and coverage.
• Promote awareness of current regulatory expectations across clinical and commercial manufacturing platforms and incorporate identified trends into audit program strategy and focus.
• Conduct and support global GMP and GDP audits of Gilead internal manufacturing sites and external partners, including contract manufacturers, laboratories, suppliers, distributors, and other third parties, spanning multiple modalities including small molecules, biologics, and medical devices/combination products.
• Drive consistency and quality in audit observation writing, finding classification, risk assessment, and documentation.
• Identify, assess, and appropriately escalate compliance risks and systemic issues to management to support timely evaluation and resolution.
• Evaluate, govern, and implement the appropriate use of AI enabled tools and digital solutions to enhance audit effectiveness, consistency, and efficiency across the global audit program.
• Collaborate with cross‑functional stakeholders to identify compliance gaps, emerging risks, and opportunities for proactive compliance or continuous improvement initiatives.
• Provide expert guidance on the interpretation and application of new and existing regulatory requirements and advise audit team, management, and functional areas on complex compliance matters.
• Support the evaluation, development, and implementation of processes, procedures, tools, templates, and systems necessary to maintain a robust global audit program that drives continuous improvement and proactive compliance across Gilead's global supply chain.
• Oversee systems and data used to manage the global audit program, including ensuring accuracy and integrity of information within Gilead's internal systems.

Senior Manager, Technical SME Standards

Director, Commercial Learning and Development – US Liver

Director, Commercial Learning and Development

Associate Director, Public Affairs

Director, Biostatistics – Virology

Director, Market Access – Trade Strategy

Director, Market Access – Trade Strategy

Executive Director, Clinical Development, MD

Vendor Management Specialist

Senior Director, US Customer Experience and Patient Services

Clinical Program Manager

Senior Regulatory Affairs Associate, CMC

Manager, Biostatistics

Director, Regional Marketing – South Central

Director, Quality Compliance, Audits