Gilead Sciences

Director

• Drives assigned initiatives/projects and working groups ensuring progression to achieve timelines.
• Oversees Clinical Operations process management/improvement and associated procedural documentation in collaboration with business process owners, cross-functional stakeholders, and subject matter experts.
• In collaboration with R&D Quality's Process, Documentation & Learning team, provides expert direction to teams to business process owners, cross cross-functional stakeholders, and subject matter experts.
• Performs content review and quality control for a portfolio of documents ensuring alignment with Gilead policies, procedures, and best practices.
• Proposes and implements plans to resolve organizational process issues and execute process-related corrective actions resulting from inspections/audits.
• Synthesizes operational/performance/compliance data and present business cases clearly to initiative review committee(s).
• Collaborates with key stakeholders to assess process alignment and prioritize revisions as necessary to ensure continued relevance and applicability of processes and associated procedural documents.
• Drives standardization and the adoption of best practices across the Clinical Operations organization.
• Ensures Clinical Operations processes and associated procedural documents are aligned with industry and regulatory expectations/regulations (i.e. 21 CFR, ICH E6 (R2)).

Associate Director, Connect Process

• Provide clinical oversight and medical monitoring to one or more clinical trials
• Lead project teams to design and implement clinical studies
• Write protocols, investigator brochures, clinical study reports and review clinical trial documents
• Conduct investigator meetings and lead site initiation visits with clinical trial investigators
• Implement and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets
• Translate findings from research and nonclinical studies into clinical development opportunities
• Interact with clinical investigators and thought leaders
• Work with internal regulatory affairs team and other ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines
• Work with internal pre-clinical scientists, translational scientists, business and commercial organizations in a cross functional manner
• Provide clinical expertise and input for regulatory filings (i.e., BLA, MAA) as well as response to questions from regulatory authorities in the context of IND submissions, clinical trial applications or filing procedures
• Provide clinical guidance and work in a team environment in interactions with external stakeholders (medical experts, advisory boards, patient advocacy groups) and internal stakeholders (Research, Translational Sciences, Clinical Operations, Safety, Regulatory, Medical Affairs, and Commercial)
• May present scientific information at scientific conferences as well as clinical study investigator meetings
• Where applicable, takes a lead on authoring scientific publications
• May assist in the clinical evaluation of business development opportunities

Director, Clinical Development – MD

• Provide clinical oversight and medical monitoring for one or more clinical trials in neurology and/or autoimmune disease
• Contribute to the design and implementation of clinical studies, including early-phase and proof-of-concept trials
• Draft and/or review protocols, protocol amendments, investigator brochures, clinical study reports, informed consent forms, safety narratives, and other clinical trial documents
• Participate in investigator meetings, site engagement activities, and selected site initiation activities with clinical trial investigators
• Support execution of clinical development plans by identifying study risks, proposing mitigations, and helping track milestones, deliverables, and budget-conscious study decisions

Engineer

• Utilize industry best practices to conduct the design, development, qualification, and implementation of packaging and labeling materials for temperature-controlled, sterile products
• Qualify shipping methods and processes to ensure the safe delivery of life-saving therapies
• Own the design, qualification, and use of label printing, inspecting, and application equipment
• Utilize sound project management methodology and tools to propagate a culture of organization and timeliness in the management of project tasks, schedules, and risks
• Maintain awareness of all government regulations as they pertain to packaging and labeling materials, components, processes, and products
• Investigate complaints/deviations and develop solutions for issues related to logistics, packaging (materials and design), labeling, and cold chain transport
• Write package material specifications and packaging process instructions for new and existing packaging
• Provide support for lifecycle management of cold chain packaging and labeling components
• Provide packaging and shipping expertise to support both internal and external logistics and supply chain partners
• Comply with the company’s change control procedures to ensure that only approved packaging materials and processes are used
• Identify alternate suppliers, as appropriate
• Work closely with internal partners, Materials Management, Quality, and Manufacturing to provide packaging and labeling solutions
• Successfully operate in a fast paced and dynamic cross-functional environment

Senior Packaging Engineer

Project Manager

• Lead projects/programs managed by the Product Launch and Change Planning (PLCP) function.
• Supports planning and execution of PLCP initiatives.
• Manage organization of new cross-functional project teams, define objectives and scope, identify tasks and milestones, build project schedules, identify resource needs, track execution to schedule and budget, and manage risks.
• Provide leadership to the project team and functional areas to anticipate and identify project issues which pose a challenge to achieving strategic goals.
• Utilize project management best practices to efficiently manage project planning and execution.
• Establish project metrics to manage and continuously improve project performance.
• Assess project components and tasks, offering solutions to problems or ways to improve.
• Works in partnership with project leaders to lead and ensure timely, efficient, and effective project meetings, as well as adequate progress of team activities between meetings.
• Chairs or co-chairs project team meetings and is responsible for documenting meeting minutes as well as tracking decisions, action items, and spending.
• Manages project communications and ensures all project stakeholders are fully informed and knowledgeable of project activities and their status.
• Interacts frequently with other functional areas.
• Collaborate with functional managers to assign appropriate skillset to projects and provide performance feedback.
• Manage and resolve conflict within the project team.

Manager, Project Management

• Drives assigned initiatives/projects and working groups ensuring progression to achieve timelines.
• Oversees Clinical Operations process management/improvement and associated procedural documentation in collaboration with business process owners, cross-functional stakeholders, and subject matter experts.
• Provides expert direction to teams to business process owners, cross cross-functional stakeholders, and subject matter experts.
• Performs content review and quality control for a portfolio of documents ensuring alignment with Gilead policies, procedures, and best practices.
• Proposes and implements plans to resolve organizational process issues and execute process-related corrective actions resulting from inspections/audits.
• Synthesizes operational/performance/compliance data and present business cases clearly to initiative review committee(s).
• Collaborates with key stakeholders to assess process alignment and prioritize revisions as necessary.

• Drive the development and execution of comprehensive regional communications and advocacy strategies
• Establish clear goals and measurable KPIs in collaboration with internal stakeholders
• Collaborate with global Public Affairs teams to shape and deliver a compelling corporate and brand story
• Design and drive communications and advocacy initiatives for new product launches
• Provide counsel to the regional Commercial leadership team and cross-functional leaders
• Build and maintain relationships with key internal and external stakeholders
• Lead and support the country teams across the region
• Proactively manage financial resources

Executive Director, Public Affairs

Manager

• Participate in the development and maintenance of global clinical data standards, including operational (eCRF and non-eCRF) data mappings
• To develop operational mappings, utilize Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM), controlled terminology, and other applicable industry standards.
• Managing work assignments to ensure timely delivery of global library objects
• Identify and resolve issues that may negatively impact the delivery of global library objects and escalate to leadership as needed.
• Subject Matter Expert (SME) on operational data standards utilizing SDTM standards and CDISC controlled terminology in developing operational data standards.
• Support and participate in the Standards Core Committee (SCC).
• Partner with functional area stewards and organize standards topics to be reviewed and ensure decisions are made on time.
• Document meeting minutes and other discussions.
• Provide input and information to facilitate critical discussions and decisions regarding standards use and implementation.
• Support preparation of materials for the Standards Governance Committee (SGC) and address all comments received until all objects in scope get approved.
• Build, maintain, and document the Medidata Rave global library standard objects (e.g., eCRF forms, edit checks) to facilitate the creation of study-level databases.
• Work with Data Managers and EDC Programmers to implement new or modified global library objects.
• Build and maintain CRF Completion Guidelines for all standard forms.
• Follow procedural documents and participate in reviewing and updating documents to ensure they reflect industry standards and are easily followed.
• Communicate and reinforce content and interpretation of Kite data standards to project and study teams to ensure consistency in understanding and implementing standards across a project.
• Participate in relevant study and project team meetings as standards SME and provide input for standards components.

Senior Manager, Clinical Programming – Clinical Data Standards Management

Operations

• Assess and approve any changes to Apheresis Collection Module, courier tracking, order intake and order processing systems to assure validated state of the systems is maintained.
• Assist in the management of an apheresis and treatment center (ATC) qualification process using risk-based tools for qualification, training, monitoring and disqualification.
• Collaborate with our Commercial operations in the routine management of the ATC relationships and Supply Chain for courier qualification and monitoring processes.
• Perform a variety of audits, qualify and monitor compliance to qualification requirements.
• Maintain the monitoring schedule and approved ATC list.
• Assist with resolution of ATC and courier issues and discrepancies, and the investigations to resolve the issues.
• Support and/or own quality records (Deviations, CAPA, Change control, etc.)
• Assist in development, implementation and management of ATC management system (GVault)
• Support inspection readiness plans and interact with regulatory agencies during inspections on ATC-related matters, as needed.
• Ability to travel up to 40%

Manager, Quality Operations

Supply Chain

• Senior Manager, Global Clinical Supply Chain is a leader that who carries out leadership vision and directions while providing expertise for Gilead's global clinical trials.
• Works collaboratively within the department and with cross functional colleagues to develop strategies, meet project deliverables, and solve business problems.
• The position has end-to-end leadership and accountability for clinical supply management.
• Prioritizes and creates executable work plans to ensure on time in full, safe delivery of investigational medicinal products (IMP).
• The role may have people leadership accountabilities which include recruiting, onboarding, developing, retaining and managing staff.
• Ensures accurate inventory and records at depots through timely reconciliation.
• Keeps abreast of clinical supply incidents and issues. Reports and escalates issues as well as investigates root cause as appropriate.
• Provides subject matter expertise for the design, development, configuration and user acceptance testing (UAT) as related to IMP management in accordance with clinical study protocol.
• Uses data to enable department’s optimization in demand and supply forecasting, inventory management and supply chain visibility.

Senior Manager, Global Clinical Supply Chain

• Oversees strategy and execution for clinical master production planning across multiple programs or sites
• Ensures an agile, compliant supply of investigational medicinal products to support global trials in unpredictable conditions
• Includes planning leadership, risk governance, and decision support across functions, balancing trial needs with capacity, inventory, and timelines
• Manages clinical master data creation and maintenance
• Has people leadership accountabilities which include recruiting, onboarding, developing, retaining and managing staff
• May have accountability for the strategy, implementation and management of digital tools and systems that support Global Clinical Supply Chain

Senior Manager, Master Production Planning – Clinical Supply

• Drive the development and execution of comprehensive regional communications and advocacy strategies that align with business objectives and portfolio priorities.
• Leverage insights, trends, and analytics to inform strategies, and provide business leaders with real-time counsel on external developments.
• Collaborate with global Public Affairs teams to shape and deliver a compelling corporate and brand story.
• Design and drive communications and advocacy initiatives that support new product launches.
• Provide counsel to the regional Commercial leadership team and cross-functional leaders on reputational impacts.
• Build and maintain relationships with key ICR and Global internal and external stakeholders.
• Lead and support the country teams across the region to plan and execute country plans.

• Provide input into product development strategies and/or research or clinical development plans
• Author the clinical pharmacology plan for assigned products
• Manage design and conduct of clinical pharmacology studies
• Design clinical pharmacology study protocols and data analysis plans
• Collaborate with cross-functional partners to monitor clinical pharmacology studies
• Manage study timelines and resources
• Conduct PK-PD and related analyses
• Analyze and author documents for clinical and regulatory submissions
• Represent clinical pharmacology for project teams in interactions with regulatory agencies

Associate Clinical Pharmacology Director

• 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
• Identify appropriate portfolio and product specific service metrics and KPIs
• Develop Mature Product channel strategy and work with Trade Account, Contracts, Operations and Regulatory
• Lead strategic insights generation via primary research and data analytics
• Collaborate with cross-functional partners/stakeholders
• Attend outside meetings or conferences
• Work closely with Auditing, Regulatory, Legal and other partners/stakeholders
• Demonstrate strong Gilead core values – Integrity, Excellence, Accountability, Teamwork, and Inclusion

Director, Market Access – Trade and Distribution

Content Writer

• Develop expertise in the preparation of a wide range of documents, with a focus on protocol development
• Work collaboratively within cross-functional teams (eg, Regulatory Affairs, Clinical Development, Patient Safety, Biostatistics, Clinical Pharmacology, Clinical Operations) to lead protocol development for large clinical programs
• Drive document strategy
• Oversee internal and external medical writers on protocols and amendments to ensure the highest quality of medical writing and adherence to Gilead content and quality standards
• Independently author a wide variety of clinical/regulatory documents such as protocols and amendments, ICFs, CSRs (all phases), and IBs according to regulatory requirements and internal Gilead document standards
• Author high complexity documents such as integrated CTD summaries/overviews, PSPs, PIPs/PIP modifications, or regulatory responses with some input from a more senior CSD team member
• Participate in development/improvement of document standards, templates, and processes and other non-medical writing activities

Associate Director, Connect Process

Director, Clinical Development – MD

Director, Clinical Development – MD

Senior Packaging Engineer

Manager, Project Management

Associate Director, Connect Process

Executive Director, Public Affairs

Senior Manager, Clinical Programming – Clinical Data Standards Management

Manager, Quality Operations

Senior Manager, Global Clinical Supply Chain

Senior Manager, Master Production Planning – Clinical Supply

Executive Director, Public Affairs

Associate Clinical Pharmacology Director

Director, Market Access – Trade and Distribution

Senior Manager, Content Strategy & Development – Protocol Lead