Gilead Sciences

Auditor

• Independently conduct and support global GMP and GDP audits of Gilead internal manufacturing sites and external partners
• Manage the end‑to‑end audit lifecycle, including audit planning and scheduling
• Develop and execute risk‑based audit strategies and agendas
• Partner cross‑functionally with Gilead stakeholders
• Contribute to the development, implementation, and continuous improvement of audit procedures
• Identify compliance gaps, quality risks, and systemic issues
• Ensure consistency, clarity, and quality in audit observation writing
• Perform due diligence assessments and supplier qualification activities
• Support audit program metrics, continuous improvement initiatives, and established performance goals

Associate Director – Auditor, Quality Compliance and Audits

Manager

• Lead the management of CDM deliverables in coordination with internal and external cross-functional teams
• Lead by providing CDM expertise for data coordination, collection, and cleaning to ensure high quality data
• Perform the execution of end-to-end Data Management activities (e.g., eCRF development, Data Review, study lock)
• Develop and manage data management timelines to meet study goals
• Oversee External Data Management activities by providing project level support
• Anticipate obstacles and difficulties of stakeholders and staff
• Manage the development and finalization of CDM documents for the eTMF
• Review and manage the eTMF for completeness and accuracy
• Serve as a primary point of contact for Data Management activities
• Ensure completeness, accuracy, and consistency of clinical data across all projects
• Responsible for data review, query management, and metric report delivery to study teams
• Coordinate study timelines and database snapshots for analysis and safety review meetings
• Participate in internal audits as well as Health Authority audits
• Participate in the development, review, and implementation of processes affecting CDM
• Proactively provides input to continuous improvement activities within Clinical Data Management
• Demonstrates efficacy in web-based Electronic Data Capture systems (e.g., Medidata Rave)

Manager, Clinical Data Management

Director

• Lead U.S. advocacy strategy across Gilead’s Oncology portfolio
• Shape and advance Gilead’s position as an emerging oncology leader by elevating the patient’s voice
• Partner externally to address unmet needs
• Work closely with U.S. Commercial, Medical Affairs, and Government Affairs teams
• Represent U.S. Oncology Public Affairs on cross-functional teams
• Design and implement advocacy partnerships and programs

Senior Director, U.S. Public Affairs, Oncology Advocacy

General Counsel

• Draft, structure, and negotiate wide, diverse types of agreements for Technical Operation functions, including confidentiality agreements, materials, consulting agreements, services agreements, vendor agreements, evaluation agreements, development agreements, licenses, work orders, and master agreements.
• Counsel clients on various legal projects, including reviewing contracts, identifying issues and liability, protecting company’s assets and intellectual properties, interpreting relevant laws and regulations, and discussing questions or suggestions with clients or other attorneys.
• Serve as the main legal advisor and business partner to assigned projects and functions.
• Advise Technical Operation business teams on legal issues arising from interactions and agreements with external parties related to manufacturing, quality, development, and supply chain.
• Facilitate the evaluation, selection, negotiation, and management of third-party vendors in support of business relationship.
• Review proposed publications, press releases, and external disclosures.
• Prepare clear, concise, and complete legal documents, opinions, reports, correspondence, and other communications.
• Develop materials for internal practices and trainings.
• Implement and meet with business to roll-out new processes and procedures.
• Liaise and partner with clients, internal global legal members, and cross-functional business teams.
• Collaborate with other attorneys in different legal practice and manage outside counsel.
• Develop and maintain a detailed understanding of assigned projects; make preliminary recommendation to management.
• Presents on legal issues, case law, and relevant regulations.

Senior Counsel

Supply Chain

• Interprets clinical study protocols and/or dosing schema
• Translates the information to IMP demand and supply planning requirements, distribution strategies including depot inventory management
• Performs demand and/or supply forecasting and planning with planning horizon of 9 to 18 months
• Develop and implements depot and clinical site seeding and resupply strategies
• Collaborate with Logistics management and other members of GCSC, PDM and external partners to resolve shipping related issues

Supply Chain Manager

• Own and drive the U.S. advocacy strategy for a late-stage oncology asset
• Set vision, priorities, and engagement strategies with advocacy partners
• Develop and maintain a cohesive patient narrative
• Advise and partner with senior leaders across Commercial, Medical Affairs, and Government Affairs
• Represent U.S. Oncology Public Affairs on cross functional teams
• Support U.S. product launches and key clinical/regulatory milestones
• Drive global to local alignment across Gilead Oncology and Kite Public Affairs
• Design and implement advocacy partnerships and programs

Senior Director, Public Affairs, Oncology Advocacy

• Lead the digital quality function with full accountability for strategy, execution, and performance.
• Build and direct a diverse digital quality team; drive cross-functional collaboration with IT, manufacturing, regulatory, and supply chain
• Champion digital transformation (automation, AI/ML, advanced analytics) across all GMP quality activities, ensuring harmonization and standardization including SaMD, eQMS, and data platforms.
• Partner with senior executive leadership on strategic issues with Gilead-wide impact.
• Build collaborative relationships across functions and with external partners to drive innovation and compliance.
• Oversee, Develop and maintain the Quality Management System (QMS) for digital health products and GxP computerized systems.
• Ensure compliance with global regulatory requirements (FDA, EMA, ICH, GDPR, 21 CFR Part 11).
• Support Gilead inspections with a focus on GxP digital Compliance (CSV, Data Integrity etc.).
• Oversee validation lifecycle for systems such as Veeva Vault and LIMS.
• Define and execute the digital quality roadmap in partnership with IT, Clinical, Regulatory, and Product Development.
• Guide and integrate agile software development in a regulated environment.
• Lead risk assessments and CAPA processes for digital systems.
• Drive innovation through advanced technologies such as AI, machine learning, and data analytics.
• Provide expert guidance and training on digital quality principles.
• Mentor and develop talent, fostering a culture of inclusion, accountability, and continuous improvement.

Executive Director, Head of Digital Quality

• Responds to unsolicited medical requests regarding Gilead products from HCPs, members of the public, and internal Gilead colleagues.
• Responses are provided in a timely manner using approved scientific response documents, up-to-date literature support, and other resources.
• Uses scientific and MI expertise to drive strategic initiatives and empower Gilead partners, HCPs, and patients to enable timely, informed decisions and improved patient outcomes.
• Performs appropriate medical review for promotional and/or medical materials.
• Prepares global scientific resources in collaboration with local affiliate teams.
• Identifies, reports and records adverse events and product complaints in a timely manner in accordance with SOP.
• Contributes to development of GMI strategy and represents GMI cross-functionally.
• May lead department-wide and/or global projects, initiatives, and product launches.
• Develop and maintain a deep knowledge of product, disease state and competitor landscape for assigned therapeutic area.
• Respond to unsolicited requests for medical and scientific information regarding Gilead products and documents in the request handling system.
• Research and collaborate with cross-functional colleagues to address complex requests.
• Create, update, and participate in review, quality check and approval of MI response documents.
• Collaborate with affiliate MI and relevant internal partners who may include medical affairs, development, regulatory, global patient safety and operations, commercial, to manage global response topics and content.
• Prepare and approve data on file to support response documents and complex requests.
• Maintain document repository with routine review of approved documents for new data from regulatory updates, scientific conferences, up-to-date literature searches, proactive literature surveillance, or newly published materials.
• Understand the needs and preferences of internal and external partners and customers.
• Review and provide analysis of MI databases for trends, customer insights and data gaps to guide content development and prepare customer interaction reports to share with internal stakeholders.
• Participate and support MI booths at scientific congresses.
• Serve as liaison for department specific training for new staff members, cross-functional colleagues and vendors, as required.
• Contribute to departmental strategic initiatives by supporting key activities within the TA, including product launches, labeling updates, patient engagement etc.
• Execute and drive global MI initiatives and actions in a timely way to advance the provision of MI to improve patient care.
• Identify, report and record adverse events and product complaints in a timely manner in accordance with SOP.
• Serve as department SME for one or more product(s) or TA.
• Build and cultivate relationships with appropriate functions.

Associate Director, Medical Information

• Provide strong tactical, operational, and administrative support to the PAQ Virology Strategy team.
• Coordinate Medical Review Committee (MRC) submissions by managing preparation, tracking, revisions, and final approvals of PAQ medical materials.
• Lead updates to scientific decks and medical materials to ensure accuracy, consistency, and alignment with approved data and messaging.
• Coordinate review cycles, versioning, and stakeholder input to maintain compliance with internal standards and regulatory expectations.
• Oversee external vendor coordination by managing timelines, deliverables, and quality checks for medical content development and operational execution.
• Support vendor onboarding, contracting coordination, and compliance alignment to ensure outputs meet PAQ Medical Affairs requirements.
• Support the creation and maintenance of medical resources aligned with PAQ scientific objectives, payer evidence needs, and field team requirements.

Senior Manager, Medical Affairs – Patient Access, Quality of Care

• 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.
• Oversees and contributes to the completion of all technical and operational statistical activities for multiple development programs for a compound or equivalent through management of internal and external resources.
• Provides overall leadership for a departmental strategic initiative with experience directly supervising personnel.

Director, Biostatistics

• Orchestrate strategic execution of the US medical affairs plans by aligning key initiatives with enterprise priorities and application of insights.
• Drive the annual Plan of Action (POA) and Launch Plans, including collaboration with other functional areas where needed.
• Foster stakeholders' understanding of project aims and inherent risks during initial development, shape their expectations through scientific evidence-based dialogue, and include them in decision-making processes.
• Adapt strategies by anticipating stakeholders’ concerns, needs, and possible responses.
• Ensure existence and use of dashboards and communication strategies to effectively convey project status and progress.
• Ensure that all stakeholders are knowledgeable of project milestones, plans, and decisions through regular reporting and communication.
• Deliver clear, concise communication throughout program lifecycle from a medical affairs execution perspective.
• Own leadership team communications, providing strategic LT support and developing clear, effective written communications.
• Plan, coordinate, and execute key internal meetings and events, including on-site and off-site sessions.
• Proactively identify and mitigate challenges to strategies, projects and initiatives within and across Therapeutic Areas within Medical Affairs.
• Ensure the team and stakeholders have the right information for decisions and leads the team through problem solving, decision discussions and contingency planning, particularly with respect to complex and unique issues.
• Facilitate connectivity across other Strategic Execution employees to ensure more integrated implementation of targeted content strategies for scientific engagement, ensuring alignment with evolving business priorities.
• Manage budget tracking and financial oversight for key initiatives, including forecasting, accruals, and variance monitoring in partnership with Finance.
• Drive projects to accelerate business in a compliant and efficient manner.
• Identify gaps in strategy and execution.

Associate Director, US Medical Affairs

Communications

• Develop and own the US communications strategy for a late-stage asset.
• Serve as a senior advisor to Kite and Gilead leadership teams.
• Build and maintain a cohesive asset narrative.
• Lead communications planning and execution for major asset milestones.
• Partner with Medical Affairs and Clinical Development.
• Oversee materials through Kite and Gilead’s internal review systems.
• Direct multi-platform communications campaigns for the asset.
• Partner with Corporate Communications on proactive storytelling and issues preparedness.
• Develop internal communications and toolkits.
• Represent Public Affairs on cross-functional asset teams.
• Drive global-to-local coordination.
• Lead reputation and issues preparedness planning.
• Manage and mentor internal team members supporting the asset’s communications work.
• Lead and optimize the work of external communications, medical communications, digital, and analytics agencies.
• Oversee budget planning and resource allocation.

Senior Director, Product Communications

• Lead the management of CDM deliverables in coordination with internal and external cross-functional teams
• Lead by providing CDM expertise for data coordination, collection, and cleaning to efficiently ensure high quality data
• Perform the execution of end-to-end Data Management activities (e.g., eCRF development, Data Review, study lock) for multiple studies across therapeutic areas and/or indications
• Develop and manage data management timelines to ensure study goals and activities are met
• Oversee External Data Management activities by providing project level support of External Data Management tasks (development of Data Transfer Plans, coordination of file transfers to meet study deliverables etc.)
• Anticipate obstacles and difficulties of stakeholders and staff and acts upon them or escalates accordingly in order to meet team goals
• Manage the development and finalization of CDM documents to be filed in the eTMF
• Review and manage the eTMF for completeness and accuracy, ensuring inspection readiness
• Serve as a primary point of contact for internal and external study team members in relation to all Data Management activities
• Ensure completeness, accuracy, and consistency of clinical data and data structure across all projects on an ongoing basis
• Responsible for data review, query management, and metric report delivery to study teams
• Coordinate study timelines and database snapshots for analysis and safety review meetings
• Participate in and/or represent CDM during internal audits as well as Health Authority audits and inspections
• Participate in the development, review, and implementation of processes, policies, SOPs, and associated documents affecting CDM
• Participate in CDM and cross-functional initiatives
• Proactively provides input to continuous improvement activities within Clinical Data Management and provides the relevant support for implementation
• Flexible to changing priorities, detail-oriented, works well under pressure, and able to take on unfamiliar tasks
• Demonstrates an ability to prioritize and delegate effectively
• Demonstrates ability to assume expanded scope of responsibility with respect to volume and complexity of clinical project work
• Works collaboratively with Clinical and Statistical Programming, Clinical Operations, Biostatistics, and others study team members to meet project deliverables and timelines
• Demonstrates proficiency with web-based Electronic Data Capture (such as Medidata Rave and other clinical data management systems)
• Experienced with industry wide thesauri/dictionaries such as MedDRA and WHODD
• Demonstrates excellent verbal and written communication skills, including the ability to clearly describe critical technical CDM aspects to non-CDM staff
• Training and mentoring of junior CDM staff
• Communication and escalation of project level issues including processes, timelines, resourcing, performance, etc.