Gilead Sciences

General

• Represent Gilead's products and services to a defined customer base in the PBC/HCV division
• Generate and grow sales by achieving or exceeding targets within the West Virginia territory
• Engage healthcare practices 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-change education
• Distill complex clinical concepts into understandable messages for diverse audiences
• Build healthcare-provider relationships and develop a comprehensive territory business plan
• Monitor sales progress and adjust strategies to meet or exceed targets
• Maintain expertise in Gilead products, competitive products, and therapeutic-area disease states
• Promote appropriate use of Gilead products in accordance with compliance 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
• Model compliance and ethical behavior and report adverse events to Gilead's Drug Safety and Public Health department
• Leverage influencing and relationship skills to drive sales outcomes
• Report call activity and customer information, submit expenses, and manage the territory budget
• Stay current on technical and scientific product information, industry trends, and therapeutic-area changes
• Work autonomously to exceed goals and performance standards
• Contribute to Gilead's Inclusion & Diversity efforts

Senior Therapeutic Specialist, PBC/HCV

• Represent Gilead's products and services to a defined customer base in the PBC/HCV division
• Generate and grow sales by achieving or exceeding targets within the West Virginia territory
• Engage healthcare practices 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
• Develop and execute territory business plans
• Monitor sales progress and adjust strategies to meet or exceed targets
• Maintain knowledge of Gilead products, competitive products, and therapeutic-area disease states
• Promote appropriate use of Gilead products in compliance with applicable 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 and ethical behavior, including timely adverse-event reporting
• Build long-term healthcare-provider partnerships and drive sales outcomes
• Report call activity and customer information, submit expenses, and manage the territory budget
• Stay current on technical and scientific product information and industry trends
• Contribute to Inclusion & Diversity efforts

Compliance

• Define and execute the global trade compliance strategy aligned to corporate, supply chain, and financial objectives
• Establish global policies, procedures, and governance frameworks for import/export compliance
• Maintain oversight of export controls, sanctions, and customs regulations
• Oversee import/export activities including classification, valuation, country of origin, and licensing
• Ensure controls for Harmonized Tariff Schedule classification and customs declarations
• Provide trade guidance for product launches, clinical supply, and market expansion
• Collaborate with Tax and Finance on customs valuation, intercompany pricing, financial reporting, duty forecasting, cost visibility, accruals, and financial planning
• Lead risk assessments, mitigation strategies, internal controls, and audit readiness
• Own internal audits and support regulatory audits
• Manage export licenses, permits, and certifications and engage customs authorities and regulatory agencies
• Identify trade optimization opportunities such as FTAs, duty drawback, and inward processing
• Drive standardization of trade compliance processes and documentation
• Implement and optimize trade compliance systems such as SAP GTS or equivalent
• Enhance automation, data integrity, and reporting capabilities
• Partner with Supply Chain, Procurement, Manufacturing, Commercial, Legal, Tax, and Finance
• Advise senior leadership on trade-related risks, costs, and opportunities
• Develop enterprise-wide trade compliance training programs
• Lead and develop a high-performing global team

Associate Director, Global Trade Compliance

Medical Director

• Lead the clinical development strategy for one or more oncology programs from IND-enabling activities through proof-of-concept and early development milestones
• Provide clinical oversight and medical monitoring across clinical studies, ensuring participant safety, data integrity, and high-quality execution
• Lead cross-functional teams in the design, implementation, and execution of clinical development plans and clinical studies
• Author and review protocols, investigator brochures, clinical study reports, regulatory documents, and other key clinical development deliverables
• Provide strategic leadership for regulatory interactions and submissions, including INDs, health authority meetings, and regulatory responses
• Collaborate with Research, Translational Sciences, Clinical Operations, Safety, Regulatory Affairs, and CMC teams
• Build and maintain relationships with investigators, key opinion leaders, scientific advisors, and other external stakeholders
• Present clinical data and development strategies to governance committees, health authorities, scientific conferences, and investigator meetings
• Lead or contribute to scientific publications and presentations
• Mentor junior physicians and contribute to portfolio strategy, business development evaluations, and external innovation assessments
• Create inclusion, develop talent, and empower teams as a people leader

Senior Director, Clinical Development – MD

Clinical Scientist

• Support late-stage oncology clinical development
• Collaborate with the Clinical Scientist Program Lead on ongoing clinical trial program activities
• Collaborate on functional area activities during program implementation
• Support clinical study start-up, execution, and closeout
• Contribute to data analysis and reporting
• Support regulatory filings
• Develop study concept sheets and protocols
• Participate in protocol review discussions
• Prepare protocols, amendments, study manual sections, Investigator meeting notebooks, and other documents
• Contribute to CRFs, Data Management Manuals, and Data Analysis Plans
• Address scientific and procedural questions from Investigators
• Contribute to data listings, summary tables, study results, manuscripts, and scientific presentations
• Assist with regulatory documents
• Anticipate clinical study obstacles and implement solutions with guidance
• Coordinate teams and provide direction when requested
• Provide clinical monitoring for clinical studies or study components
• Summarize published scientific information for new study development
• Adhere to regulatory requirements, Good Clinical Practice, and Gilead SOPs
• Create inclusion, develop talent, and empower teams as a people leader

Senior Clinical Development Scientist

• Lead the clinical development strategy for one or more oncology programs from IND-enabling activities through proof-of-concept and early development milestones
• Provide clinical oversight and medical monitoring across clinical studies, ensuring participant safety, data integrity, and high-quality execution
• Lead cross-functional teams in designing, implementing, and executing clinical development plans and studies
• Author and review protocols, investigator brochures, clinical study reports, regulatory documents, and other clinical development deliverables
• Provide strategic leadership for regulatory interactions and submissions, including INDs and health authority meetings
• Collaborate with Research, Translational Sciences, Clinical Operations, Safety, Regulatory Affairs, and CMC teams
• Build and maintain relationships with investigators, key opinion leaders, scientific advisors, and external stakeholders
• Present clinical data and development strategies to governance committees, health authorities, scientific conferences, and investigator meetings
• Lead or contribute to scientific publications and presentations
• Mentor junior physicians and contribute to portfolio strategy, business development evaluations, and external innovation assessments
• Create inclusion, develop talent, and empower teams as a people leader

• Support late-stage oncology clinical development
• Collaborate with the Clinical Scientist Program Lead on ongoing clinical trial program activities
• Collaborate on functional area activities during program implementation
• Support clinical study start-up, execution, and closeout
• Contribute to data analysis and reporting
• Support regulatory filings
• Develop study concept sheets and protocols
• Participate in protocol review discussions
• Prepare protocols, amendments, study manual sections, Investigator meeting notebooks, and related documents
• Contribute to CRFs, Data Management Manuals, and Data Analysis Plans
• Address scientific and procedural questions from Investigators
• Contribute to data listings, summary tables, study results, manuscripts, and scientific presentations
• Assist with regulatory documents
• Anticipate obstacles and implement solutions with guidance
• Coordinate teams and provide direction when requested
• Provide clinical monitoring for clinical studies or study components
• Summarize published scientific information for new study development
• Adhere to regulatory requirements, Good Clinical Practice standards, and Gilead SOPs
• Create inclusion, develop talent, and empower teams as a people leader

• Lead the clinical development strategy for one or more oncology programs from IND-enabling activities through proof-of-concept and early development milestones
• Provide clinical oversight and medical monitoring across clinical studies, ensuring participant safety, data integrity, and high-quality execution
• Lead cross-functional teams in designing, implementing, and executing clinical development plans and studies
• Author and review protocols, investigator brochures, clinical study reports, regulatory documents, and other clinical development deliverables
• Provide strategic leadership for regulatory interactions and submissions, including INDs, health authority meetings, and regulatory responses
• Collaborate with Research, Translational Sciences, Clinical Operations, Safety, Regulatory Affairs, and CMC teams
• Build and maintain relationships with investigators, key opinion leaders, scientific advisors, and external stakeholders
• Present clinical data and development strategies to governance committees, health authorities, scientific conferences, and investigator meetings
• Lead or contribute to scientific publications and presentations
• Mentor junior physicians
• Contribute to portfolio strategy, business development evaluations, and external innovation assessments

Director

• Provide strategic and operational statistical leadership for clinical development programs within the Virology Therapeutic Area
• Serve as lead statistician for Phase 1–3 clinical trials
• Represent Biostatistics on study management teams and development teams
• Collaborate with Clinical Development, Patient Safety, Clinical Pharmacology, Regulatory Affairs, Project Management, Programming, and Clinical Data Management
• Provide statistical input into study design, clinical development plans, sample size determination, and protocol development
• Author statistical analysis plans and review tables, figures, listings, and clinical study reports
• Oversee and lead technical and operational statistical activities for groups of clinical trials
• Direct internal and external teams in statistical activities for molecules or marketed products
• Advise on statistical analysis strategies, measurement reliability, model identifiability, and interpretation and presentation of results
• Review and analyze safety reporting, biomarker analyses, and clinical trial monitoring data
• Use advanced statistical software and methods to analyze historical and external data
• Provide biostatistical input into clinical development documentation, scientific publications, presentations, and regulatory documentation
• Participate in or lead special projects, innovative methodologies, processes, technology, tools, and SOP development
• Adhere to regulatory requirements, statistical analysis principles, industry standards, and Gilead SOPs
• Create inclusion, develop talent, and empower teams as a people leader

Associate Director – Biostatistics

• Represent Gilead's products and services to a defined customer base in the St. Louis territory
• Generate and grow sales by achieving or exceeding sales targets
• Manage healthcare accounts through in-person representation, face-to-face meetings, and strategic partnerships
• Establish relationships with healthcare providers
• Deliver disease awareness information, clinical updates, and education on healthcare changes
• Distill complex clinical concepts into understandable messages for diverse audiences
• Build relationships with healthcare providers across various touchpoints
• Develop and execute territory business plans
• Monitor sales progress and adjust strategies to meet 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
• Collaborate with healthcare organizations and partner companies, including co-promotion efforts
• Uphold compliance standards and ethical behavior
• Report adverse events to Gilead's Drug Safety and Public Health department
• Leverage influencing and relationship skills to drive sales outcomes
• Report call activity and customer information in designated systems
• Submit expenses and manage the territory budget
• Stay current on industry trends and therapeutic-area developments
• Work autonomously to exceed performance standards
• Contribute to Inclusion & Diversity efforts

Prevention Specialist, HIV

• Lead a team of direct reports and typically manage other people leaders
• Support multiple disease areas, a whole therapeutic area, or another significant area within Biostatistics
• Contribute to short- and long-range Biostatistics strategies, plans, and infrastructure development across Development functions and workstreams
• Consult with executives to envision future direction and prioritize investment and strategic business decisions
• Build and lead high-performing cross-functional teams
• Direct complex, multi-functional programs and initiatives
• Integrate, interpret, and strategically use data from diverse internal and external sources
• Serve as a trusted advisor and contributor to senior leadership
• Develop deep subject-matter expertise and act as a company-wide resource
• Communicate scientific and statistical concepts to internal and external audiences
• Collaborate across Development and other functions to drive alignment, decision-making, and execution
• Oversee a large, complex portfolio of programs and projects
• Create inclusion, develop talent, and empower teams

Senior Director, Biostatistics

• Support a portfolio of early lifecycle and pipeline programs across multiple disease areas
• Lead defined scientific communication workstreams spanning publication strategy and execution, scientific narrative development, evidence translation, congress activity and Medical Affairs content
• Develop and maintain evidence-based scientific narratives as clinical evidence, the external scientific landscape and program priorities evolve
• Develop and review field medical resources, FAQs, congress materials and other scientific communication assets
• Adapt scientific communications to audiences, formats and channels while maintaining accuracy, balance and consistency
• Partner with field medical teams and stakeholders to understand scientific exchange needs and translate complex evidence into practical resources
• Monitor and synthesize external scientific, clinical and treatment landscape developments
• Translate scientific and stakeholder insights into communication strategy, content development and evidence dissemination recommendations
• Support congress strategy, planning and execution
• Ensure alignment across publications, scientific narratives, congress activity and Medical Affairs content
• Ensure communications comply with company policies, governance processes, Medical, Legal and Regulatory review requirements and external standards
• Translate program objectives, Medical Affairs priorities, scientific evidence and landscape developments into publication priorities and executable plans
• Guide development, scientific review and delivery of peer-reviewed manuscripts, congress abstracts, posters, oral presentations and related deliverables with agency partners
• Partner with subject-matter experts, external authors, investigators, alliance partners and stakeholders on publication tactics
• Represent Publications in cross-functional forums and provide updates, recommendations and escalation of material issues
• Contribute to Global Publication Planning Team discussions and maintain publication plan documentation
• Oversee publication vendors, medical writing partners and external resources, including scope, timelines, scientific quality and performance

Associate Director, Medical Affairs

• Provide strategic and operational statistical leadership for clinical development programs within the Virology Therapeutic Area
• Serve as lead statistician for Phase 1–3 clinical trials, with responsibility for overall statistical strategy and delivery
• Represent Biostatistics on study management and development teams
• Collaborate with Clinical Development, Patient Safety, Clinical Pharmacology, Regulatory Affairs, Project Management, Programming and Clinical Data Management
• Provide statistical input into study design, clinical development plans, sample size determination and protocol development
• Author statistical analysis plans and review TFLs and clinical study reports
• Oversee and lead technical and operational statistical activities for groups of clinical trials
• Direct internal and external teams in statistical activities for molecules or marketed products
• Advise on statistical analysis strategies, measurement reliability, model identifiability and interpretation of results
• Review and analyze safety reporting, biomarker analyses and clinical trial monitoring data
• Use advanced statistical software, methods and techniques to analyze historical and external data
• Provide biostatistical input into clinical development documentation, scientific publications, presentations and regulatory documentation
• Participate in or lead special projects, innovative methodologies, processes, technology, tools and SOP development
• Adhere to regulatory requirements, statistical analysis principles, industry standards and Gilead SOPs
• Create inclusion, develop talent and empower teams as a people leader

Associate Director, Biostatistics

• Lead or support integrated global CMC regulatory strategies for T-cell drug product and lentiviral vector programs
• Serve as Regulatory CMC representative on program and technical teams
• Convert program decisions into regulatory requirements, submission plans, health authority engagement strategies, risks, mitigations, and decision points
• Define phase-appropriate CMC content and evidence expectations
• Provide regulatory guidance for autologous T-cell manufacturing processes and assess manufacturing process changes
• Guide T-cell control strategy, including quality attributes, process parameters, in-process controls, specifications, potency, identity, purity, viability, safety testing, and comparability criteria
• Support site additions, technology transfers, manufacturing network expansion, process performance qualification, comparability, validation, and post-approval change strategies
• Provide regulatory guidance for lentiviral vector manufacture and assess LVV process and analytical changes
• Guide LVV control strategy and develop regulatory approaches for LVV comparability and bridging
• Define phase-appropriate IND/CTA CMC packages and prepare or review submissions, amendments, health authority questions, and regulatory meeting materials
• Drive CMC readiness for pivotal studies and BLA/MAA submissions
• Lead or support responses to information requests, deficiency letters, and health authority meeting questions
• Assess post-approval changes and change controls
• Support inspection readiness by aligning filings with site practices, validation status, manufacturing history, quality systems, and commitments
• Author, coordinate, and critically review CMC sections for INDs, CTAs, BLAs, MAAs, supplements, variations, amendments, annual reports, renewals, and post-approval commitments
• Maintain registered details, regulatory commitments, correspondence, assumptions, and decision history
• Present status, risks, options, and recommendations to technical teams and leadership
• Contribute to Regulatory CMC templates, playbooks, precedents, intelligence, and training
• Coach less experienced colleagues and fulfill people-leader accountabilities

Senior Manager, Regulatory Affairs CMC

• Lead or support integrated global CMC regulatory strategies for T-cell drug product and lentiviral vector programs
• Serve as Regulatory CMC representative on program and technical teams
• Translate program decisions into regulatory requirements, submission plans, health authority strategies, risks, mitigations, and decision points
• Provide regulatory guidance for autologous T-cell manufacturing across production, testing, storage, shipping, and chain-of-identity/chain-of-custody controls
• Assess T-cell and LVV process, analytical, equipment, supplier, site, scale, formulation, and manufacturing changes
• Guide T-cell and LVV control strategies, comparability, bridging, validation, stability, potency, safety, and reference standards
• Define phase-appropriate IND/CTA CMC packages and support early-stage development
• Prepare and review CMC content for submissions, amendments, scientific advice, and regulatory meetings
• Drive CMC readiness for pivotal studies, BLA/MAA submissions, commercial readiness, and post-approval lifecycle activities
• Author, coordinate, and review CMC sections for INDs, CTAs, BLAs, MAAs, supplements, variations, amendments, annual reports, renewals, and commitments
• Support inspection readiness, site additions, technology transfers, manufacturing network expansion, and post-approval changes
• Present status, risks, options, and recommendations to technical teams and leadership
• Contribute to Regulatory CMC templates, playbooks, precedents, intelligence, and training
• Coach less experienced colleagues and lead selected Regulatory CMC sub-teams or special initiatives
• Create inclusion, develop talent, and empower teams as a people leader