Gilead Sciences

Manager

• Provide support for advanced portfolio planning within Planisware, including the creation of scenario-based plans
• development of new project and study plans
• ensuring data is complete, accurate, and reliable to support portfolio decisions
• provides cross-functional Planisware system related support, troubleshooting, and issue resolution
• Monitoring data quality within Kite systems, dashboards, and reports used for portfolio planning and resource forecasting
• Ensure dashboards and reports use the same metrics and definitions across functions
• Provide Planisware training to new and existing Kite users
• Develop, maintain, and update G.Plan support materials, process documentation, and user training resources
• Support Planisware user acceptance testing, system upgrades, releases, and sprint activities to ensure stable and effective application performance
• Oversees user access, security permissions, and use of sensitive business data

Senior Manager, Clinical Trial Planner, Data Steward

Compliance

• Define and lead global CMC regulatory strategy for CAR‑T programs across early and late clinical development and post‑approval lifecycle management
• Anticipate evolving global expectations for ATMPs/CAR‑T and proactively assess regulatory risks, opportunities, and mitigation strategies
• Represent Regulatory CMC as a senior leader on cross‑functional governance and core teams
• Provide executive oversight and critical review of Module 3 / Quality content for clinical and commercial applications
• Ensure end‑to‑end consistency, scientific rigor, and regulatory defensibility of CMC dossiers, including in‑context review of compiled applications and health‑authority responses (e.g., RTQs, IRs)
• Serve as a senior CMC subject‑matter expert for health authority interactions, including briefing documents and participation in agency meetings
• Lead global CMC regulatory assessments for manufacturing and control changes, including process evolution, site transfers, comparability strategies, analytical changes, and shelf‑life updates
• Drive lifecycle strategies that balance regulatory compliance, technical feasibility, supply continuity, and business objectives
• Oversee complex global LCM planning, including sequencing, regional differences, and submission pathways
• Provide strategic regulatory guidance to technical teams throughout product development, scale‑up, validation, and commercialization
• Partner closely with Manufacturing, MSAT, Quality, and external CDMOs to ensure regulatory‑compliant execution
• Review and provide oversight of CMC components supporting labeling, product information, and related regulatory documents
• Lead, develop, and mentor a team of Regulatory CMC leaders and/or provide strong matrix leadership across programs
• Set priorities and oversee resources, and timelines for a complex portfolio of submissions and lifecycle activities
• Contribute to the advancement of Regulatory CMC capabilities, processes, and best practices globally

Senior Director, Regulatory Affairs CMC

Director

• Provide strategic and operational leadership for Kite’s auto immune portfolio, and pipeline assets in solid tumors
• Shape and execute global Medical Affairs strategy across the product lifecycle
• Partner closely with Clinical Development, HEOR, Market Access, Government Affairs, Marketing, and regional Medical Affairs teams
• Lead Medical Affairs contributions to launch planning, ensuring scientific readiness
• Engage with the global medical community, building and maintaining a strong thought leader network
• Ensure the continuous development and training of Medical Affairs team members
• Collaborate effectively and compliantly with colleagues in Clinical Research, Sales, Marketing, Market Access, and PVE

Senior Director, Global Medical Affairs – Auto Immune & Pipeline

• Provide global regulatory CMC leadership and strategy across the development, lifecycle management, and commercialization of cell therapy and viral vector–based products
• Lead the development, compilation, review, and maintenance of CMC sections for global regulatory submissions
• Serve as a key strategic interface between Global Regulatory Affairs, Research, Technical Operations, Quality, and external partners
• Ensure global harmonization of CMC content across submissions
• Assess manufacturing change controls for global regulatory impact
• Identify CMC regulatory risks and develop mitigation strategies
• Guide technical teams on global CMC regulatory requirements throughout development and post-approval stages
• Independently manage and prioritize multiple complex programs and submissions

Director, Regulatory Affairs CMC

• Lead all operational and lifecycle management aspects of Regulatory CMC submissions (e.g., INDs, IMPDs, BLAs, MAAs, variations, amendments) supporting global clinical and commercial CAR‑T programs
• Serve as the Regulatory CMC lead on assigned program and/or platform teams, applying advanced knowledge of global CMC regulatory requirements for autologous cell therapies
• Author, review, and coordinate Module 3 (M3) content, ensuring global alignment and harmonization across regions (US, EU, and other international health authorities)
• Develop and execute CMC regulatory strategies that align with overarching regulatory and business strategies, including support for global site additions, process changes, raw material changes, analytical updates, and shelf‑life extensions
• Proactively identify CMC regulatory risks and lead scenario planning, including anticipation of regulator questions and development of mitigation and contingency plans
• Assess and provide regulatory impact evaluations for CMC changes through formal change control processes, ensuring appropriate global regulatory strategies are defined and executed
• Support interactions with global health authorities by contributing to briefing packages, written responses, and regulatory meeting preparations specific to CMC topics
• Collaborate cross‑functionally to ensure CMC deliverables meet regulatory requirements, quality standards, and program timelines
• Support continuous improvement and best‑practice sharing for Regulatory CMC processes in a rapidly growing, dynamic environment

Manager, Regulatory Affairs – CMC

• Development and execution of global HEOR strategies to maximize access to anitocabtagene autoleucel in RRMM
• Support the development and maintenance of global economic models, systematic literature reviews, and indirect treatment comparisons
• Collaborate extensively with RWE & HEOR team for payer/provider interactions and reimbursement submissions
• Create and comment on study concept documents, protocols, analysis plans, and final study reports
• Manage external HEOR consulting companies

Associate Director, Global HEOR

• Single, accountable leader of a Product Team, providing strategic leadership to drive development and execution of product strategy aimed at maximizing the value of the asset.
• Owns global asset vision and lifecycle for the designated asset.
• End-to-end lifecycle ownership including long-term commercial value
• Accountable for stage-gate progression and operationalization of strategy
• Facilitates Go/No-Go decisions
• Escalates risks and recommendations, drives execution within governance
• Balances science with commercial and medical insights, accounting for provider, payer and patient considerations.
• An enterprise leader accountable for clear and timely communication about the product throughout the enterprise with early engagement of key stakeholders.
• Partnering with key stakeholders and Kite leadership to align product strategy with broader disease area program strategy and Kite corporate strategy.
• Serving as the enterprise decision integrator for the asset, accountable for identifying trade-offs across development, medical, regulatory, technical operations—recognizing the unique complexity, risk profile, and early-stage importance of technical operations engagement in cell therapy—and commercial considerations and making recommendations to maximize long term enterprise value.
• Present product updates, strategic issues, options, and recommendations to the Portfolio Committee on behalf of the Product Team.
• Lead Product Team meetings and ensures cross-functional Product Team Members are working in alignment on strategic and operational topics.
• Partner with cross-functional leaders to develop comprehensive product development and life-cycle management plans that optimize value, time, resources, risk, and alignment with business objectives.
• Drive progression of products through Development and Commercialization stage gates and ensure that:
• Product Teams have adequate resources and technical expertise to meet strategic objectives
• Issues are raised, discussed, and resolved in a timely manner
• Product Teams receive leadership input & decisions in a timely manner
• Product Teams adhere to agreed-upon priorities, scope, timelines, resources, and budget
• Create a high-performance team culture within the Product Team through collaboration and coaching of cross-functional team members.
• Ensure rigorous adherence to quality and compliance.

Executive Director, Product Team Leader

Procurement

• Develop and refresh global category strategies and sourcing plans aligned to clinical development objectives.
• Drive global vendor strategy and provide input into program and study level vendor strategies.
• Accountable for category performance, results, and value delivery.
• Lead end-to-end sourcing and contracting lifecycle, including RFI/RFP, bid evaluation, vendor selection, negotiation, change orders, and closeout.
• Lead negotiations for complex/high-value agreements, translating business, scientific, and legal requirements into contract terms and budgets.
• Ensure compliant vendor selection and sourcing practices through risk management, benchmarking, and alignment with Legal, Quality, and Vendor Qualification.
• Partner with cross-functional stakeholders to develop study requirements, sourcing strategies, and vendor selection decisions.
• Drive cost containment and value through benchmarking, market intelligence, and use of standard rate cards.

Senior Category Manager – Specialty Labs

Clinical Operations

• Establish and maintain strong professional and collaborative relationships with investigator sites by leveraging disease area expertise to optimize delivery of clinical trial programs
• Develop strategies to drive concierge level support for preferred sites to ensure Gilead becomes the Sponsor of Choice
• Track key performance metrics to assess site performance and identify opportunities for acceleration and continuous improvement
• Establish and manage strong working partnerships with local PAGs and communities, including liaising with patient groups in relation to protocol development and study design considerations
• Serve as an internal resource to champion and promote an environment that incorporates the patient perspective and voice across the continuum of product development based on patient insights obtained from local PAGs and communities
• Identify investigator sites, PAGs and communities in alignment with portfolio strategy and priority to expand Gilead’s clinical research partnership network
• Maintain therapeutic and technical expertise to enable scientific discussions with the investigator and site personnel
• Share ongoing information with investigators, PAGs and communities regarding Gilead's development pipeline and collect and report field-based intelligence in relation to competitive landscape, patient treatment pathways and other operational considerations that may impact Gilead's clinical trial program
• Provide support to study teams and Clinical Research Organizations (CROs) to ensure timely delivery of clinical trials from initiation to closeout such as during feasibility, site recommendations, attendance at initiation visits, facilitation of communication and ongoing support of trial enrollment by engaging with site staff to identify enrollment barriers and working with study teams to find solutions
• Support the development and implementation of applicable site risk plans to ensure achievement of key study and site level milestones such as first patient first visit, delivery of clinical trial enrollment commitments and database lock
• Serve as a local point of escalation for investigator sites and partner with the appropriate parties to resolve issues and remove barriers to clinical trial execution at a site and/or country level
• Proactively communicate and escalate issues identified at investigator sites and partner with internal functional areas to develop corresponding mitigation strategies and recommended approaches, including participation in development and implementation of solutions to address issues
• Leverage and present metrics to inform site / country / regional level decision making
• Develop local knowledge of investigator site capabilities and past performance and provide input into site-level recruitment forecasts, recruitment methodologies, monitor performance and take appropriate action to maintain timelines
• Partner closely with internal Clinical Operations, Clinical Development and Medical Affairs to ensure effective communication and unified messaging to investigator sites, PAGs and communities

Associate Director, Clinical Operations, Clinical Site Partner – Inflammation

Human Resources

• Develop and execute communications strategies that support talent, culture, and organizational priorities
• Serve as a primary strategic and trusted advisor to the CHRO of Human Resources and HR Leadership Team
• Lead the creation, review, and refinement of executive-level materials
• Partner closely with the Communications Center of Excellence to ensure coordinated execution across all channels
• Support executive preparation and coaching for internal and external engagements

Senior Director, Human Resources – Public Affairs

• Serve as a primary strategic and trusted advisor to the CHRO of Human Resources and HR Leadership Team on business positioning, narrative development, stakeholder engagement, and reputational considerations.
• Anticipate risks and opportunities, independently identifying communications needs and proactively shaping executive narratives.
• Develop and execute communications strategies that support talent, culture, and organizational priorities, including transformation initiatives and workforce engagement.
• Lead the creation, review, and refinement of executive-level materials including speeches, business updates, town halls, talking points, Q&A documents, and external thought leadership that support long-range commercial priorities.
• Translate HR strategy, talent priorities, and organizational changes into clear, compelling messaging that supports alignment and engagement.
• Partner closely with the Communications Center of Excellence, including Internal Communications, Employee Engagement Media Relations, Digital and Social, and Issues Management, to ensure coordinated execution across all channels.
• Lead cross-functional coordination across HR, Public Affairs, Legal, and other functions to ensure alignment and consistency.
• Support communications planning and execution during periods of organizational change or sensitive workforce-related issues.
• Support executive preparation and coaching for internal and external engagements, including industry events, media interactions, and leadership forums.
• Leverage employee feedback, engagement data, and insights to refine communications strategies.
• Manage external agencies and advisors supporting communications programs.

• Coordinating and supervising all aspects of a clinical study
• Monitors clinical trial sites
• Assists Clinical Program Manager in overall study management
• Drafts and coordinates review of relevant documents
• Maintains study timelines
• Contributes to development of study budget
• Manage CROs/vendors
• Ensures effectiveness of site budget/contract process

Clinical Trials Manager

• Coordinating and supervising all aspects of a clinical study
• Monitors clinical trial sites
• Assists Clinical Program Manager in overall study management
• Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports
• Maintains study timelines
• Contributes to development of study budget
• Contributes to development of RFPs and participate in selection of CROs/vendors
• Manage CROs/vendors
• Coordinates review of data listings and preparation of interim/final clinical study reports
• May contribute to development of abstracts, presentations, and manuscripts
• Ensures effectiveness of site budget/contract process
• May be asked to train CROs, vendors, investigators, and study coordinators on study requirements

• Lead a team to drive U.S. communications and advocacy about Gilead’s HIV Treatment portfolio and pipeline
• Set a vision and priorities for the team, provide direction as well as hands-on support as needed
• Engage with leaders in U.S. commercial, Medical Affairs and Government Affairs to help drive cross-functional strategy
• Integrate information from across the organization to ensure comprehensive “one PA” approach in HIV treatment
• Lead cross-functional efforts to horizon scan and proactively address emerging issues
• Design and implement disease awareness programs
• Support ongoing and pending product launches in the U.S.
• Maintain relationships with key top-tier and trade reporters
• Manage agency partners and budgets

Executive Director, Public Affairs – U.S. HIV Treatment

• Provide Statistical leadership to late-stage oncology clinical trials: developing trial design options and providing high quality decision support.
• Statistical lead for a specific oncology molecule/indication in Health Authority interactions and maintain an accountability thread to TA head
• Works collaboratively with Statistical Programmers, Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for statistical data analysis and reporting
• Directs internal and external teams across multifunctional project or functional areas, leads initiatives to gather, organize, and analyze data from different sources such as virology, Case Report Forms, and patient tracking, works with management and Human Resources to satisfy short-term staffing needs, defends statistical aspects with regulatory agencies, develops staff capabilities, and recognizes/rewards desired performance
• Is expected to oversee and contribute to the completion of all technical and operational statistical activities for a group of clinical trials for a compound/indication or equivalent through management of internal and external resources
• Leads two or more components of departmental strategic initiatives

Senior Manager, Clinical Trial Planner, Data Steward

Senior Director, Regulatory Affairs CMC

Senior Director, Global Medical Affairs – Auto Immune & Pipeline

Director, Regulatory Affairs CMC

Manager, Regulatory Affairs – CMC

Associate Director, Global HEOR

Executive Director, Product Team Leader

Senior Category Manager – Specialty Labs

Associate Director, Clinical Operations, Clinical Site Partner – Inflammation

Senior Director, Human Resources – Public Affairs

Senior Director, Human Resources – Public Affairs

Clinical Trials Manager

Clinical Trials Manager

Executive Director, Public Affairs – U.S. HIV Treatment

Director, Biostatistics