Amgen

Manager

• Provide statistical, technical, operational, and business leadership for CSM
• Serve as the business owner for Amgen’s CSM analysis system, signal framework, and analytical workflows
• Provide leadership for the CSM Statistics team and accountability for statistical deliverables supporting the CSM capability
• Partner with the Head of CSM / CfDA Safety to shape and execute the strategy, roadmap, and operating model for CSM
• Advance CSM methodology within the broader RBQM framework to support Quality by Design, data quality, data integrity, and study quality oversight
• Prioritize CSM system enhancements, signal development, automation opportunities, and related RBQM analytical needs, including QTL approaches
• Support governance, documentation, inspection readiness, and long-term sustainability of the CSM capability
• Lead statistical review, interpretation, documentation, and release of CSM signals across clinical studies
• Support study teams in understanding signal outputs, statistical rationale, and appropriate follow-up actions
• Provide statistical judgment on unusual signal patterns, data quality concerns, operational risks, and potential study-level or site-level issues
• Lead, coach, and develop statisticians and colleagues supporting CSM activities

Senior Manager, Centralized Statistical Monitoring

Compliance

• Work to ensure that Amgen acquires and maintains all the required licenses to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products
• Support one or more products from a regional regulatory perspective
• Plan and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements
• Implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements
• Provide content guidance for regional regulatory documents and meetings in accordance with global strategy
• Provide regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plans)
• Support regional label negotiation activities
• Participate in the development, and execution of regional regulatory product strategies
• Develop predictions for expectations and risks associated with outcomes by regulatory agencies
• Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products
• Perform regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement
• Evaluate and communicate impact of relevant regional regulations, guidances, current regulatory environment and competitor labelling

Regulatory Affairs Manager

• Serve as the regulatory product planning lead for a key obesity asset, maintaining an integrated view of regulatory priorities, milestones, dependencies, and risks across multiple indications.
• Develop and maintain a comprehensive Regulatory Product Plan that aligns regulatory objectives and activities, health authority interactions, development milestones, and major business priorities.
• Partner with Global Regulatory Leads (GRLs), regional regulatory leads, and regulatory functional representatives to drive alignment on key deliverables, timelines, risks, and execution strategies.
• Establish and maintain visibility into critical regulatory milestones, ensuring leadership has a clear understanding of readiness, risks, dependencies, and potential impacts to regulatory objectives.
• Facilitate regulatory planning forums to support decision-making, issue resolution, and proactive management of emerging regulatory challenges.

Global Regulatory Submission Planning Sr. Manager – Obesity

Operations

• Lead the strategy, governance, transformation, and execution of continuous improvement initiatives across the Research & Development (R&D) Quality organization
• Drive scalable, efficient, compliant, and data-driven processes that enhance quality oversight across GCP, GLP, GVP and research functions
• Lead governance frameworks, strategic project management, and Quality support for business development activities
• Develop and execute a multi-year Operational Excellence roadmap aligned to R&D Quality strategy and enterprise priorities
• Establish and lead governance processes for the R&D Quality
• Drive R&D GXP quality governance models to ensure adequate quality performance and escalation from L2 through L0
• Support Global Quality efforts, representing R&D quality, on quality governance as needed
• Drive annual goal setting, portfolio prioritization, budget tracking, and business performance reviews
• Identify and lead/monitor cross-functional improvement initiatives across audits/inspections, quality systems, CAPA, supplier quality, and oversight models
• Establish project management standards, tools, and governance for strategic Quality initiatives
• Lead a portfolio of enterprise and functional projects ensuring scope, timelines, resources, risks, and deliverables are managed
• Represent R&D Quality in acquisition assessments, licensing opportunities, and strategic partnerships
• Lead Quality due diligence and execute post-close integration plans for acquired assets
• In partnership with Global Development, establish KPIs to measure quality performance, efficiency, risk, and project delivery
• Build operational excellence and project management capability through coaching, training, and mentoring
• Act as a trusted advisor to senior leaders, bringing insights and thought leadership on operational performance
• Demonstrate foresight in identifying emerging challenges and opportunities (“looking around corners”).

Senior Director, Operational Excellence

Director

• Lead the global strategy, execution, and continuous improvement of the internal and external audit program supporting the Research & Development (R&D) Quality organization.
• Provide independent assurance that systems, processes, vendors, and clinical trial operations comply with applicable GxP regulations, internal standards, and industry expectations.
• Oversee risk-based audit programs across GCP, GLP, Pharmacovigilance, computerized systems, data integrity, and vendor oversight.
• Partner closely with R&D Quality leadership, Global Development, Safety, Regulatory Affairs, and external partners to strengthen compliance, inspection readiness, and proactive risk management.
• Develop and execute a global, risk-based GxP audit strategy aligned to quality and portfolio priorities.
• Build and lead a high-performing audit organization.

Senior Director, R&D GxP Audit

Account Manager

• Drive business performance across a strategically important North West territory, building strong partnerships with key stakeholders across thoracic oncology.
• Translate national brand strategy into effective local execution, develop account plans, and work collaboratively with cross-functional teams to support appropriate and compliant use of our lung cancer portfolio while helping improve patient outcomes.
• Own the business for the North West territory, developing and maintaining robust account and territory plans across priority accounts.
• Build insight into local lung cancer pathways, stakeholder networks, access challenges, and opportunities.
• Deliver high-quality, compliant customer engagement with healthcare professionals and decision-makers.
• Drive sales performance through effective account management, prioritisation, and execution.
• Identify opportunities to strengthen local advocacy in line with brand strategy and compliance requirements.
• Collaborate with medical, market access, marketing, healthcare solutions, and leadership teams to address barriers and maximise opportunities.
• Use CRM, Veeva, and account planning tools to track activity, manage commitments, and support business decisions.
• Share customer and market insights to inform strategy, enhance execution, and improve patient impact.

Regional Account Manager

Marketing

• Join Amgen’s Mission of Serving Patients
• Help create enterprise value by testing new technologies and novel ways of working across the LVL portfolio and scaling proven innovations
• Support portfolio brands by leading strategic marketing initiatives, omnichannel tactics, and experimentation efforts
• Partner with Brand Marketing, Business Analytics & Insights, Media, Medical, Value & Access, Patient Support, and cross-functional partners to identify business opportunities
• Develop testable hypotheses, execute marketing experiments, measure performance, and scale learnings across brands
• Report to the Executive Director, Brand Lead, Marketing and Experimentation Operations Lead, Lifecycle Value Lab
• Operate with strategic agility, strong executional discipline, and a collaborative enterprise mindset.

Senior Manager, Marketing – Lifecycle Value Lab

• Own and evolve Amgen’s enterprise media operating model across HCP and DTC investments, ensuring disciplined execution, scalability, and consistency across brands, channels, and partners
• Lead media operations and platform strategy, serving as the enterprise owner for media technology platforms, activation tools, and operational workflows that connect media strategy, execution, and measurement
• Provide hands‑on leadership across media planning, buying, activation, and measurement platforms, including Prisma, SA360, DCM and Ad Managers, DSPs, publisher platforms, and media planning tools such as Guideline
• Partner with analytics, data, and IIT teams to operationalize media data within enterprise environments, leveraging platforms such as Snowflake, S3, and Tableau to enable structured, accessible, and actionable insights
• Establish and govern enterprise media standards across tracking, tagging, naming conventions, platform access, data schemas, and agency file requirements to support accurate reporting, attribution, and compliance
• Ensure strong alignment between media activation platforms and downstream measurement, reporting frameworks across internal teams and agency partners
• Lead agency onboarding, enablement, and ongoing governance, ensuring adherence to Amgen media standards, data integrations, platform workflows, and platform usage expectations
• Monitor the evolving media and technology landscape, identifying opportunities to modernize tools, processes, and partnerships while strengthening Amgen’s approach to privacy, compliance, and responsible media activation
• Drive continuous improvement, education, and change management across media operations and measurement practices to elevate enterprise media fluency and capability.
• Build, lead, and develop a high‑performing team, fostering accountability, collaboration, and innovation in support of Amgen’s long‑term media transformation.

Director, Media Operations – Technology

Full-stack Engineer

• Lead the Global Reliability Network
• Lead a network of site reliability engineers, maintenance leaders, system owners, and technical SMEs.
• Develop and execute the Reliability Network strategy, goals, milestones, and maturity plans.
• Share reliability KPIs, bad actor trends, equipment improvements, lessons learned, and reusable solutions.
• Represent reliability priorities and recommendations in senior engineering governance forums.
• Turn data insights into equipment improvements
• Use CMMS data, Asset Performance Monitoring, Plant Pulse, PdM findings, and site input to identify recurring failures, high-risk assets, downtime drivers, and bad actors.
• Convert reliability insights into corrective actions, equipment improvements, PM/PdM optimization, spare parts strategies, and capital recommendations.
• Track improvement actions, verify benefits, and scale successful practices across sites.
• Advance asset criticality and maintenance strategy
• Define and maintain a standard risk-based asset criticality approach across sites.
• Use criticality to prioritize maintenance strategies, work execution, spare parts, lifecycle planning, and performance monitoring.
• Standardize maintenance strategies based on criticality, failure modes, operating context, and performance history.
• Support RCM, FMEA/FMECA, PM optimization, predictive maintenance, and condition-based maintenance approaches.
• Lead Asset Performance Monitoring and PlantPulse adoption
• Define business requirements for asset health, criticality, failure modes, risk ranking, performance monitoring, and continuous improvement.
• Partner with SAP EAM, Technology/IS, site engineering teams, the Reliability Network, and SMEs to support deployment, training, adoption, and data quality.
• Serve as PlantPulse business owner to ensure tools address reliability pain points, support troubleshooting, and generate actionable equipment insights.
• Connect reliability to business value
• Partner with OPEX teams to identify reliability improvements that unlock capacity and reduce downtime.
• Translate recurring failures and reliability constraints into business impact.
• Support lifecycle risk visibility for critical assets, including deterioration, obsolescence, maintenance cost, reliability concerns, and end-of-life planning.
• Integrate reliability principles into capital projects from conceptual design through turnover.

Principal Engineer – Global Reliability Network Lead

Clinical Research

• Support late-phase clinical development by contributing to protocol development, study start-up, data review and monitoring, and analysis activities
• Working collaboratively with the study team and clinical leadership to ensure high-quality, decision-ready clinical data
• Assist in authoring clinical protocols, Investigators Brochures, and other regulatory documents ensuring consistency and clarity
• Provide input into & implementation of data management plan, CRF design, and data review oversight
• Support review, analysis, and presentation preparation of clinical trial data for internal decision making, external interactions, and regulatory submission
• Assist Development Lead and Clinical Scientist Director in medical monitoring and management of collaborators, consultants, and/or Clinical Research Organizations in completion of key projects
• Anticipate and actively manage problems across a broad spectrum of cross-functional teams
• Work cross-functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol, and related documents
• Support appropriate training, recruitment, and development requirements for matrix team resources

Clinical Scientist Associate Director, Late Development, Obesity

• Responsible for the development, characterization, scale‑up, and support of drug substance cell culture and purification processes
• Lead and develop a multi‑site organization of 30+ scientists and engineers
• Drive program success, safety culture, technical excellence, innovation, automation, and digital strategies
• Support a diverse portfolio of biologics, including monoclonal antibodies (mAbs), BiTEs, bispecifics, biosimilars, and other novel protein‑based modalities
• Play a key role in advancing late‑stage and commercial drug substance strategies across Amgen’s manufacturing network
• Lead a high‑impact, multi‑functional drug substance organization integrating cell culture and purification disciplines across multiple sites
• Recruit, develop, and retain a strong and diverse team; manage portfolio prioritization and organizational resourcing
• Advance integrated drug substance processes through commercial process development, process characterization, lifecycle management, and control strategy development
• Partner with engineering, manufacturing, and external network collaborators to enable successful process transfer and commercialization
• Author and review global regulatory filings (IND/INDa/MA) and respond to regulatory agency questions
• Drive ideation, development, and deployment of innovative and differentiating bioprocess technologies
• Contribute to Amgen’s scientific and regulatory eminence through publications, patents, and participation in external conferences and forums.

Senior Director, Bioprocess – Process Development

• Lead Amgen’s business development efforts in identifying and evaluating innovative therapeutics being developed outside of Amgen
• Develop and nurture a network of key industry and academic contacts
• Ensure robust communication of ideas, interests and information between the external community and internal groups
• Manage the search and identification of opportunities through networking and reviews of the external landscape
• Assess and prioritize based on Amgen’s therapeutic area strategy
• Lead the technical evaluations of opportunities by creating and managing cross-functional review teams
• Provide recommendations based on robust scientific and drug industry knowledge
• Ensure appropriate and efficient decision-making processes
• Engage in business negotiations and work with legal to execute contractual agreements for certain projects
• Responsible for leading strategic discussions and presentations with senior management, R&D, and Commercial.

Director of External Research – Development

Administrative Assistant

• Support Executive Directors within the Global Marketing organizations for General Medicine and Inflammation.
• Manage complex and frequently changing calendars for Executive Directors across multiple time zones.
• Coordinate domestic and international travel arrangements, including itineraries, visas, meeting logistics, and expense reporting.
• Support document management, including compliance-related administrative activities, presentations, and briefing materials.
• Screen and prioritize communications, ensuring timely responses, follow-up, and escalation when needed.
• Process purchase orders, invoices, and contracts in accordance with Amgen policies.
• Support onboarding activities for new team members and contractors.
• Maintain organizational charts, distribution lists, team calendars, and shared resources.
• Support leadership meetings, global team meetings, offsites, workshops, and virtual events.
• Coordinate logistics for cross-functional and international meetings, including scheduling, catering, technology support, attendee management, and congress support.
• Prepare meeting minutes, track action items, and ensure follow-through across stakeholders.
• Identify opportunities to streamline processes, improve team operations, and bring forward practical ideas that enhance coordination, engagement, and ways of working.
• Support team culture, engagement activities, and recognition efforts with positive energy, sound judgment, and a collaborative spirit.
• Partner effectively with Commercial, Medical, Value & Access, Corporate Affairs, Finance, HR, Legal, and other functions.

Administrative Coordinator – Global Marketing, General Medicine, Inflammation

• Supports the design, execution, and oversight of cardiovascular trials and other late-phase global clinical studies.
• Contributes to protocol development, study execution, medical monitoring support, and clinical data review, ensuring delivery of high-quality, decision-ready clinical data for regulatory submissions and scientific dissemination.
• Support the design, start-up, and execution of global cardiovascular trials, ensuring adherence to protocol, regulatory requirements, and data integrity standards.
• Contribute to development of clinical protocols, statistical analysis plans, investigator brochures, and regulatory documents, with particular focus on cardiovascular endpoints and safety outcomes.
• Collaborates with cross-functional teams to support endpoint strategy, event adjudication processes, and cardiovascular safety monitoring.
• Participates in development and oversight of endpoint adjudication charters, safety monitoring plans, and Data Monitoring Committee (DMC) interactions.
• Provides clinical input into data management plans, CRF design, and clinical data review, with focus on cardiovascular outcomes endpoints (e.g. MACE, hospitalization events, mortality) and/or cardiac imaging endpoints.
• Conducts ongoing clinical data review and signal detection, supporting identification and resolution of safety and data quality issues across global trial sites.
• Supports preparation and interpretation of interim analyses, database lock activities, and top-line data readouts.
• Assists Development Lead and Clinical Scientist Director with medical monitoring activities and oversight of CROs, vendors, and adjudication committees.
• Collaborates with clinical operations, biostatistics, safety, regulatory, and medical affairs teams to ensure successful delivery of cardiovascular outcomes and/or cardiac imaging studies.
• Contributes to clinical study reports, regulatory submissions, scientific publications, and presentations for internal and external stakeholders.
• Identifies operational or scientific risks and proactively implement mitigation strategies across cross-functional teams.

Clinical Scientist Associate Director, Cardiovascular

• You’ll help shape how marketing tactics are planned, produced, and deployed across channels, working in close partnership with U.S. Brand teams and cross-functional partners.
• As a key connector between brand strategy and execution, you’ll drive more consistent, efficient, and impactful commercial delivery — while contributing to implementation of new processes, tools, and ways of working.
• You’ll work cross-functionally with Brand Marketers, Content Production teams, Media and Channel Operations teams, and Data & Analytics partners to deliver coordinated, effective and efficient commercial activation.
• Work closely with the Obesity brand marketing team to drive coordinated execution of customer capabilities in collaboration with GCCI Transformation teams, Media, Production, and Channel Operations teams, and Business Analytics & Insights partners.
• Lead weekly pod interactions across GCCI channel operations teams to uncover insights for optimization and expand capability utilization for brand benefit.
• Educate and drive usage of new self-service tools and centralized capabilities to enable the brand team to efficiently find, re-use, create, and deploy content as technology evolves.
• Share channel-specific best practices and toolkits to enable Brand team execution at scale.
• Support development and implementation of cross-channel pilots or test-and-learns related to new formats, journeys, and automation.
• Document results, learnings, and best practices to uplift content capabilities, including contributing to global standards and Amgen Brand Management training curriculum.
• Monitor and keep pace with the latest industry content innovations and recommended practices.
• Partner with GCCI BAI and decision science teams to deliver performance tracking and operational dashboards to assess execution quality, content utilization, and deployment efficiency.
• Act as a key liaison to enterprise platform owners (e.g., DAM, Veeva, MLR systems) to ensure system alignment and content flow.