Amgen

Manager

• Oversee the execution of high-quality GCP & IVDR Inspection Readiness & Preparation
• Own the Site Inspection Readiness & Preparation project management for all clinical trials and programs covering early, late, and observational programs
• Participate in developing and implementing innovative cross-functional Inspection Readiness (IR), Inspection Preparation, and Operational Quality (OQ) initiatives
• Lead GCP & IVDR Regulatory Site Inspection Readiness and Preparation project management using tools, materials, apps and systems
• Leading teams through smooth inspection experiences and successful inspection outcomes
• Innovate continuous improvement in operational quality inspection readiness by identifying and acting on program, study and site quality incidents
• Maintain and manage IR SharePoint (SPO) site
• Providing mentorship to student interns

Inspection Readiness Manager

Account Manager

• In this vital role you will be responsible for representing TEPEZZA to physicians and health care professionals, establishing product sales, and performing total territory account management.
• The Specialty Account Manager is responsible for providing account management support to accounts within a specific geography in the designated marketplace with a focus on issues specific to their designated accounts.
• The SAM acts as central account manager; responsible for driving product demand and coordinating relevant field teams to address account needs.
• Develops a comprehensive and effective territory business plan aimed at achieving and exceeding annual sales goals established by sales and business unit leadership.
• Promotes TEPEZZA within approved labeling in a comprehensive, fair and ethical manner that is consistent with industry specific and corporate legal and regulatory guidelines.
• Addresses issues related to access, pull-through, and reimbursement by coordinating with key stakeholders and matrix team members.
• Develops strong customer relationships by better understanding the customer’s needs and goals and communicating those needs and goals to other team members.
• Consistently meets or exceeds corporate sales goals.
• Communicates territory activity in an accurate and timely manner as directed by management.
• Drive product demand among targets through education on disease state and product information.
• Provides feedback to sales and business unit leadership, colleagues, and other internal departments about changing environment and results.
• Adheres to the Company’s compliance policies and guidelines and any other applicable guidelines, including but not limited to the PhRMA code.
• Must be able to work closely with patient services and market access team members, and understand their roles, to achieve overall business goals.
• Coordinate between accounts and relevant Amgen field teams to support full range of account needs.
• Educate healthcare professionals and office staff on site of care options.
• Attends medical congresses and society meetings as needed.
• Manages efforts within assigned promotional and operational budget.
• Maximizes use of approved resources to achieve territory and account level goals.
• Successfully completes all Company training classes.
• Completes administrative duties in an accurate and timely fashion.
• Functions as a contributing member of a high-performance team.

Account Manager – Specialty – Ocular, Rare Disease

• Responsible for the development and maintenance of departmental software utilities to support the analysis and reporting of clinical trial data for GSP
• Maintain and develop re-usable software utilities for GBS and GSP
• Provide technical leadership and guidance for programming teams
• Oversee FSP programming team
• Provide guidance and support to ensure their operational success
• Partner with IS to maintain and enhance GSP systems and ensure that they are meeting the needs of statistical programming
• Coordinate and collaborate with CfDA on design and implementation of statistical analysis and reporting applications
• Create, maintain, and review key SDLC documents -Requirements, Operational Qualification, Installation Qualification, and Design documents
• Create, maintain, and review end-user documentation (e.g., user guides, training materials)
• Participate in establishing the programming scope, timeline and quality for deliverables with stakeholders
• Participate in the selection of appropriate technologies and software development tools based on GSP priorities and budget
• Make and ensure the implementation of high level strategic decisions, including GSP strategy for adopting newer programming (R, Python, and other)
• Designated team leader responsible for project efficiency, timeliness and quality
• Manage resource according to priorities
• Match programmer abilities to tasks
• Efficiently and optimally monitor and utilize assigned staff
• Provide input in the development and review of GSP SOPs and other controlled documents
• Provide input into and help facilitate career development plans for all staff on assigned projects
• Provide mentorship to staff

Senior Biostatistical Programming Manager

Director

• Report to the Oncology Strategy Executive Director
• Serve as a scientific and strategic leader for Amgen’s Partners of Choice (APoC) academic collaboration network
• Engage directly with external key opinion leaders, academic investigators, and physicians as a scientific peer
• Partner with senior R&D stakeholders to translate scientific insights and external perspectives into clear priorities and actionable recommendations
• Bring structure to complex scientific and business challenges and drive execution across cross-functional initiatives
• Lead and influence cross-functional teams in a matrixed environment to advance collaboration objectives
• Synthesize complex scientific data and external insights to inform senior leadership decision-making and portfolio strategy
• Design and oversee external collaborations to ensure they are scientifically rigorous, operationally sound, and deliver meaningful outcomes
• Oversee key operational elements (e.g., budget, contracting, resource planning) in service of strategic objectives
• Lead high-impact engagements, including network summits and scientific meetings, with responsibility for shaping content, agendas, and external participation
• Drive continuous improvement to enhance collaboration effectiveness and overall network impact.

Director, Oncology Strategy

Digital Marketing

• Responsible for leading the planning and implementation of Ultra-Rare Brand Strategies into digital means
• Serve as a key partner to brand leadership by turning strategic goals like positioning, customer journeys, and go-to-market plans into actionable projects and requests for capabilities
• Work closely with cross-functional matrixed teams to organize tasks, set priorities, and achieve targeted brand results
• Support brand strategy execution by promoting analytics and automation tools
• Convert brand objectives into measurable KPIs and SLAs
• Maintain all current established Ultra-Rare brand and unbranded websites
• Design and oversee strategies for digital media activation and re-engagement
• Manage daily relationships with agencies and publishers
• Advocate for ongoing innovation and continual learning.

Senior Manager, Digital Marketing – Ultra-Rare Medicines

• Work with cross-functional medical and commercial account teams to gather EHR customer insights and assess opportunities
• Manage the customer accounts prioritization process for the MV Health IT Liaisons
• Contribute to the development of scalable, EHR-enabled tools and resources in relation to key therapeutic areas
• Deliver insights related to EHR objectives to key internal partners to help inform strategic decisions
• Deliver education on EHR reporting and clinical decision support tools to support health system initiatives
• Conduct regular meetings with customers to provide appropriate Health IT-related education
• Create and complete key account plans for how to navigate the customer landscape plus complete key initiatives
• Effectively assist through training and communication MSLs and KAMs on MVHIT and EHR programs and resources and provide support to field staff to address questions
• Confidently engages customers in a field facing capacity using appropriate methods and MAC approved materials/messaging
• Demonstrates effective use of CRM tool to run territory schedule and call documentation
• Support cross-functional workstreams to support business initiatives as requested for identified accounts, contributing strategic insights on care management evolution, quality and care initiatives, and HIT implementation

Medical Value and Health Information Technology Manager – Health IT Liaison

• Responsible for representing TEPEZZA to physicians and health care professionals, establishing product sales, and performing total territory account management.
• Responsible for providing account management support to accounts within a specific geography in the designated marketplace with a focus on issues specific to their designated accounts.
• Develops a comprehensive and effective territory business plan aimed at achieving and exceeding annual sales goals established by sales and business unit leadership.
• Promotes TEPEZZA within approved labeling in a comprehensive, fair and ethical manner that is consistent with industry specific and corporate legal and regulatory guidelines.
• Addresses issues related to access, pull-through, and reimbursement by coordinating with key stakeholders and matrix team members.
• Develops strong customer relationships by better understanding the customer’s needs and goals and communicating those needs and goals to other team members.
• Consistently meets or exceeds corporate sales goals.
• Communicates territory activity in an accurate and timely manner as directed by management.
• Drive product demand among targets through education on disease state and product information.
• Provides feedback to sales and business unit leadership, colleagues, and other internal departments about changing environment and results.
• Adheres to the Company’s compliance policies and guidelines and completes all Company training classes.
• Completes administrative duties in an accurate and timely fashion.
• Functions as a contributing member of a high-performance team.

Account Manager – Specialty Account Manager, Ocular, Rare Disease

Marketing

• Support priority strategic growth workstreams (e.g., PMR, Competitive Readiness, New Product Launch) by managing cross-functional alignment and on-time execution, while selectively leading tactic development.
• Identify new growth opportunities through market understanding, competitive insights, customer needs, and performance diagnostics; synthesize into clear problem statements and options.
• Support the brand leadership team in long-range planning and investment strategy by building recommendations, trade-off analyses, and decision-ready materials.
• Design and execute test-and-learn pilots (hypothesis-driven), including success metrics, implementation plans, and scaling recommendations; operationalize learnings into the brand plan.
• Build business cases and influence investment decisions; partner with key stakeholders to ensure pilots meet legal/regulatory/medical requirements and are ready for compliant scaling.
• Partner with Amgen India to identify and deliver innovative solutions that address brand challenges not currently solved by the tactical plan.
• Translate US brand needs into well-scoped innovation briefs; coordinate agile execution, learning loops, and integration back into US commercialization.
• Build and develop high-performing project teams (direct and matrix) by setting clear expectations, driving accountability, and strengthening capabilities.
• Own portions of the budget and partner with brand leadership to recommend investment choices that maximize impact and ROI.
• Ensure projects move efficiently through internal review processes and are executed with excellence (clear briefs, timelines, risk management, and stakeholder communication).
• Contribute to best-practice sharing and continuous improvement for commercial strategy, innovation, and AI-enabled ways of working across the portfolio.

Senior Manager, Marketing Strategy

Product Manager

• Identify, frame, and validate AI-enabled business opportunities across Amgen.
• Translate broad transformation themes into clear problem statements, testable hypotheses, user needs, data requirements, success metrics, and validation plans.
• Evaluate whether proposed AI opportunities have the right data foundations, system integrations, architecture patterns, model capabilities, security controls, and operational support needed to move from concept to scalable solution.
• Collaborate with data scientists, ML engineers, data engineers, software engineers, solution architects, platform teams, and cybersecurity partners to shape solution concepts, understand technical tradeoffs, and identify dependencies early in the validation process.
• Design and execute rapid discovery sprints, prototypes, pilots, user research, and experiments to assess desirability, feasibility, viability, value, and risk.
• Use evidence to determine whether opportunities should advance, pivot, pause, or scale.
• Assess how LLMs, AI agents, machine learning models, NLP, automation, knowledge retrieval, analytics, and intelligent workflow tools can improve productivity, decision quality, scientific discovery, operational efficiency, and workforce effectiveness.
• Develop product requirements that account for user experience, data availability, model performance, output quality, explainability, reliability, latency, integration needs, governance, and ongoing measurement.
• Synthesize findings from validation work into clear product recommendations, opportunity briefs, technical feasibility assessments, business cases, and executive-ready narratives.
• Help leaders make informed decisions about where to invest, scale, or stop.
• Maintain a portfolio of AI opportunity experiments across stages of discovery, prototype, pilot, and scale-readiness.
• Track progress, risks, assumptions, evidence, data dependencies, architecture implications, and decision points.
• Ensure validation efforts consider responsible AI, data privacy, model risk, cybersecurity, compliance, regulatory considerations, human oversight, change management, and enterprise scalability from the earliest stages of discovery.
• Facilitate workshops, discovery sessions, prioritization discussions, technical feasibility reviews, user experience design, process mapping, and decision forums.
• Communicate complex AI and data concepts in a clear, business-oriented way for senior leaders and non-technical stakeholders.

Digital Product Manager, Strategy and Innovation

• Integrate multiple sources of evidence, including primary research, ad hoc secondary analytics, competitive intelligence, advisory boards, internal knowledge, and cross functional input, to inform strategic decision making
• Develop and execute insights plans for key oncology & hematology assets, ensuring activities are aligned to evolving business & stakeholder priorities
• Lead primary market research across study design, research material development, execution, analysis, synthesis, and communication of implications to inform strategic business priorities
• Translate insights into actionable recommendations by connecting market, customer, access, clinical, and competitive dynamics into clear strategic implications
• Partner across Global Marketing, Value & Access, Forecasting, Competitive Intelligence, Analytics, Medical, and other functions to embed insights into business planning and decision making

Global Insights Manager, Oncology

Compliance

• Assist US Regulatory Lead (USRL) to support US regulatory activities (e.g. development and submission of Investigational New Drug [IND] applications, Biologic License Applications [BLAs] and New Drug Applications [NDAs]; advisory committee meeting preparations)
• Provide and maintain IND/BLA/NDA documentation support (e.g. annual reports, amendments) in collaboration with USRL
• Create and maintain product regulatory history documents in the regulatory document management system and appropriately archive all regulatory documents and agency communications
• Review US component of the Global Regulatory Strategic Plan (GRSP) and provide input to operational deliverables; perform regulatory research to support the development of content for the GRSP plan as delegated by the Global or US Regulatory Lead
• Actively support regulatory compliance and ensure compliance of submissions to the US FDA
• Assist the Global or US Regulatory Lead by preparing supportive documentation for regulatory deliverables, including for example regulatory landscapes or research for the regulatory strategy and/or target product label
• Coordinate collection of functional documents in support of regulatory applications
• Participate on Global Regulatory Teams (GRT) and assist Global Regulatory Leads with GRT meeting management (eg, agendas and meeting minutes)
• Assist the USRL in managing the process for responding to FDA questions
• Coordinate Quality Check (QC) of regulatory documentation (e.g. briefing packages)
• Provide primary authorship to routine regulatory correspondence (e.g. annual reports)
• Prepare regulatory packages and cross-reference letters to support investigator initiated studies
• Complete regulatory forms to support agency communications (e.g. FDA form 1571)
• Support process improvement initiatives, standards development, and metrics
• Assist in template development and maintenance
• Respond to specific requests from and communicate relevant issues to GRT
• Support the development and execution of GRT goals

Senior Regulatory Affairs Associate

Brand Manager

• Serve as a strategic thought partner to the US Brand lead and XF team helping translate insights into action and shaping brand goals and priorities
• Lead orchestration/brand operating rhythm, including team meetings, QBRs, forecasts, and weekly performance updates
• Support tracking of performance, key initiatives, and business metrics; synthesize insights for leadership
• Assist in the creation of critical business presentations and support performance updates, brand plans, sales presentations, and other strategic deliverables
• Partner with brand, finance, and XF team to align budgets with business priorities
• Act as the connective tissue across cross functional partners and initiatives including marketing, contracting, field account teams, forecasting, analytics, finance, patient access, legal, regulatory, and others to effectively work as one team
• Ensure cross-functional alignment and proactively identify execution synergy or risks
• Lead execution of select marketing initiatives, including digital and field tools
• Partner with agencies and internal teams to ensure high-quality, compliant, and on-time execution
• Partner with contracts & pricing team to support execution of key initiatives
• Ensure coordination between brand activities and access/pricing considerations where applicable

Senior Manager – Brand Strategy, Operations

Human Resources

• Serve as a trusted advisor to senior leaders across the U.S. Commercial organization, aligning people strategies to evolving business priorities and enterprise goals
• Develop and execute HR strategies that strengthen organizational effectiveness, leadership capability, employee engagement, and business performance
• Coach leaders on HR and business issues to accelerate change and improve team effectiveness
• Work with senior leaders to assess workforce capabilities, identify talent needs, and build forward-looking workforce and succession strategies
• Lead talent management initiatives including leadership development, succession planning, organizational capability building, engagement, and retention
• Partner with HR Centers of Excellence on compensation, talent planning, culture, diversity and inclusion, and workforce strategy
• Drive the attraction, development, and retention of top talent in partnership with Talent Acquisition and business leaders
• Lead organizational design efforts with leadership teams to improve agility, scalability, and business effectiveness
• Lead and influence large-scale transformation and change management initiatives across therapeutic areas and commercial functions
• Use data, analytics, and organizational insights to inform decisions, surface trends, and drive continuous improvement
• Foster a high-performing, engaged, and inclusive culture aligned with Amgen’s mission and values
• Ensure alignment with employment laws, HR policies, and business practices while balancing business objectives with a strong employee experience
• Stay current on external talent and organizational trends, bringing practical, innovative thought leadership to the business and HR organization
• Align HR and business partners to deliver integrated, enterprise-level solutions.

Human Resources Director – U.S. Commercial, Global Customer Capabilities and Innovation

• Support Clinical Development in Prostate cancer
• Supporting the development, execution and communication of the global scientific/medical evidence plan
• Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program
• Supporting the development of key scientific external relationships with opinion leaders
• Participating and providing clinical input into safety and regulatory interactions
• Provide clinical/scientific input during the development and execution of clinical trials
• Interpret clinical trial data
• Participate in safety assessments
• Participate in interactions with regulatory agencies
• Author CSRs, publications and regulatory submissions
• Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by Global Development Leader
• Identify new clinical research opportunities
• Support in-licensing and out-licensing activities and partner relationships
• Support product lifecycle management for new indications as directed by Global Development Leader
• Provide clinical content input to: Regulatory interactions and documents, Safety interactions and documents, Materials to be used in Scientific Affairs, Materials to be used by the Commercial Organization

Clinical Development Director – Oncology

• Part of Amgen’s Process Development organization, Drug Product Technologies unit
• Deliver superior, robust drug product manufacturing processes, high-quality CMC sections
• Serve as single point of accountability for individual drug product programs for technical activities specific to formulation, aseptic drug product process design and validation
• lead a scientific team advancing commercial drug product programs
• Responsible for planning, designing, executing, and documenting laboratory studies related to drug product design, formulation, and process development
• Drive continuous improvement in the drug product development process through technological innovation
• Participate and lead global cross-functional teams to influence efficiency and foster strong relationships
• Author and review guideline documents, technical protocols, reports, product impact assessments, regulatory submissions, and developing responses to regulatory questions.
• Deliver progress reports and presentations to management.