Amgen

• Act as the primary customer contact to provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products to medical professionals.
• Create and execute on a comprehensive territory plan, which includes delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets.
• Utilize your internal and external relationships to service and manage accounts, including ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts.
• Craft an effective marketing strategy to aid in driving sales.
• Analyze your business effectiveness of sales activities and territory analysis, as well as develop territory plans with your District Manager.
• Partner with other colleagues to share best practices and be in a state of continuous curiosity and learning to help you grow as a Sr. Oncology Specialist.
• Leverage your passion for Oncology and disease state awareness, Industry, regulatory and competitive changes to deliver agreed results.

Senior Oncology Specialist

Medical Director

• Be accountable for the development and execution of the global medical affairs strategy across the Hematology portfolio.
• Lead the Global Medical Affairs Hematology Team.
• Maximize Amgen’s medical value proposition, advancing evidence generation.
• Provide medical and scientific insights to support development of the Target Product Profile and asset strategy.
• Capture clinical, scientific, patient, payer, and health system insights across key markets.
• Coordinate with regions to develop and lead the external stakeholder management plan, communication strategy, scientific platform, publication plan, and evidence generation plan.
• Facilitate scientific engagement with a broad range of external stakeholders, including opinion leaders, professional organizations, advocacy groups, payers, regulators, and other healthcare decision makers.
• Provide strategic direction for study design and execution for medical affairs studies.

Medical Asset Lead Director, Oncology

• Safety expert of the assigned product(s), establishing the strategy, direction, and priorities of pharmacovigilance activities.
• Accountable for the overall safety profile and all product-related decisions and deliverables for assigned products.
• Leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC).
• Product safety profile, benefit-risk evaluation, and risk communication
• Clinical trial safety Brochure and Informed Consent Form
• New drug applications and other regulatory filings
• Risk management and minimization
• Commercialization Process
• Inspection Readiness
• Partnerships and integration activities
• Participate in safety agreement development and review process
• Prepare safety information to support licensing partners, review safety documents prepared by licensing partners, and communicate with licensing partners on safety matters per the safety agreement

Global Safety Medical Director – Global Safety Officer, Oncology

Manager

• Directs the planning, preparation, writing and review of portions of aggregate reports
• Organize and direct liaison for activities with affiliates and other internal Amgen partner regarding products
• Supports and provides oversight to staff with regards to safety in clinical trials
• Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents
• Review of AEs/SAEs from clinical trials as needed
• Review standard design of tables, figures, and listings for safety data from clinical studies
• Participate in development of safety-related data collection forms for clinical studies
• Participate in study team meetings as requested or needed
• Signal detection, evaluation, and management
• Perform data analysis to evaluate safety signals and write up analysis results
• Documents work as required in the safety information management system
• Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO
• Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
• Prepare presentation of the Global Safety Team’s recommendations on safety issues to the cross-functional decision-making body
• Assist GSO in the development of risk management strategy and activities
• Provides contents for risk management plans
• Develop or update strategy and content for regional risk management plans
• Assist GSOs to oversee risk minimization activities including tracking of activities as needed
• Evaluate risk minimization activity
• Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO
• Support activities related to new drug applications and other regulatory filings
• Assist GSO in developing a strategy for safety-related regulatory activities
• Provide safety contents for filings
• Inspection Readiness
• Undertake activities delegated by the QPPV as detailed in the PV System Master File
• Maintain a state of inspection readiness.

Senior Manager, Global Pharmacovigilance Safety – Obesity

• Ensure all statistical aspects pertaining to clinical activities meet required standards and are statistically accurate
• Lead a group of Rare Disease and/or other therapeutic area products
• Accountable and responsible for Global Statistical Programming study results and submission activities for the assigned product areas
• Set and drive forward the programming strategies such as functional standards and industry requirements for the assigned product areas globally
• Plan and monitor progress of projects and address issues accordingly
• Support GSP Functional Service Provider (FSP) relationship and oversight
• Ensure the product goals can be met via the FSP staff
• Provide GSP product level input to developing and managing resource plans and budgets for GSP
• Efficiently and effectively monitor and utilize assigned staff at product level according to priorities
• Lead and/or participate in departmental process improvement initiatives and cross-functional working groups
• Assist in study and system audits and inspections by internal and external bodies
• Develop, review, and implement Policies, SOPs and other controlled documents affecting GSP globally
• Provide hands-on support to the assigned product areas as required
• Provide coaching and mentoring to staff
• Provide input into career development plans for all staff on assigned projects.

Senior Manager, Statistical Programming

Clinical Research

• Own the development and execution of the feasibility strategy in partnership with clinical program team
• Lead the successful delivery of the feasibility process to expedite cycle times
• Manage L5 GFL Direct Reports, overseeing performance reviews, career progression, training, and engagement
• Lead activities pertaining to country and site identification, feasibility and country selection within a clinical study
• Partner with study team members, data analytics teams, and country teams to design and conduct global feasibility activities on time with high quality delivery
• Lead the collection of local internal and external data to define an optimal geographic country footprint and proposed sites for participation in a clinical study
• Synthesize, interpret and integrate data and information to provide clear feasibility recommendations
• Facilitate the study baseline enrollment commitment & change process
• Initiate and lead global feasibility continuous improvement efforts and initiatives
• Support development of systems, processes and work practices that drive rapid, accurate and robust assessments of program and protocol feasibility

Global Feasibility Senior Manager

Compliance

• Facilitate product development and global registration by developing and executing regulatory strategies
• Manage effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle
• Contribute as a member of the global regulatory CMC product team
• Interact with authors/reviewers and subject matter experts with respect to delivery of regulatory documents required for regulatory submissions
• Contribute to the organization and preparation of CMC investigational product amendments, post-market supplements/variations, and new marketing applications
• Document and archive CMC submissions and related communications in the document management system
• Initiate and maintain CMC product timelines at the direction of product lead
• Interface with the regulatory operations team
• Train staff on select CMC procedures and systems
• Provide report status of activities and projects to teams and department
• Participate in cross-functional special project teams

Senior Associate, Regulatory Affairs – CMC

• Execute U.S. regulatory strategy and deliverables for assigned programs and represent the region on global teams (e.g., GRT; may include GDT/CST/LWG as applicable).
• Plan and manage U.S. regulatory submissions (e.g., clinical trial and marketing applications) aligned with global filing plans and U.S. regulatory requirements.
• Implement product-related regulatory tactics and activity plans in accordance with U.S. legislation, regulations, and internal standards.
• Provide content guidance for key U.S. regulatory documents and meetings consistent with GRT strategy (e.g., briefing content, submission components).
• Support U.S. labeling development in collaboration with the Labeling Working Group (LWG), incorporating scientific data, guidance, and precedent; support U.S. labeling negotiation activities.
• Provide regulatory guidance on U.S. mechanisms and pathways to optimize development (e.g., expedited programs, orphan considerations, pediatric plans, compassionate use where applicable).
• Obtain and maintain clinical trial authorizations and marketing application approvals, including support for Responses to Questions (RTQs) and other agency feedback.
• Communicate regulatory strategy and expectations within the team (e.g., GRT, affiliates/stakeholders) and work with line management to assess likelihood of success, expectations, and risks.
• Ensure ongoing regulatory compliance for assigned products (e.g., IMR accuracy, PMCs/commitments, pediatric and other agency obligations); escalate issues proactively.
• Maintain and apply U.S. regulatory intelligence: monitor evolving legislation/guidance; research precedent and history; assess and communicate potential impact (including competitor labeling where relevant).
• Support Health Authority interactions by acting as an agency contact as appropriate, documenting outcomes, and contributing to risk/contingency planning consistent with global strategy.
• Partner with cross-functional teams to support alignment and execution, including U.S.-specific considerations for data use in product communications (as applicable).

Manager, Regulatory Strategy – Obesity and Related Conditions

• Support products in the Obesity and Related Conditions Therapeutic Area
• Develop and execute regulatory strategy in close partnership with the Global Regulatory Lead (GRL)
• Represent the U.S. on global teams and contribute to global regulatory and clinical development strategies
• Plan and lead U.S. regulatory submissions in alignment with global filing plans and regulatory requirements
• Lead development of key regulatory documents, including labels, briefing packages, and submission components aligned with product strategy
• Drive U.S. labeling strategy and execution in collaboration with the Labeling Working Group
• Lead Health Authority interactions for assigned products
• Assess regulatory risk and likelihood of success; communicate scenarios and contingencies to the GRL, GRT, and senior management.
• Ensure ongoing compliance for assigned products and proactively escalate issues

Senior Manager, U.S. Regulatory Strategy – Obesity and Related Conditions

Director

• Provide strategic, statistical, technical, operational, and business leadership for Centralized Statistical Monitoring (CSM).
• Accountable for the CSM analysis system, signal framework, statistical methodology, team leadership, cross-functional delivery, and continued evolution of CSM as part of Amgen’s broader Risk-Based Quality Management (RBQM).
• Lead CSM capability development across a growing clinical portfolio, ensuring that CSM remains scientifically rigorous, scalable, inspection-ready, and aligned with portfolio, regulatory, study team, and business needs.
• Serve as the business owner for Amgen’s CSM analysis system, signal framework, and analytical workflows.
• Lead the strategy, roadmap, operating model, and continued evolution of the CSM capability in partnership with the Head of CSM / CfDA Safety and cross-functional stakeholders.
• Provide leadership and accountability for the CSM Statistics team and statistical deliverables supporting the CSM capability.
• Advance conventional and innovative CSM methodology to support RBQM, Quality by Design, data quality, data integrity, and clinical study quality oversight.
• Prioritize CSM system enhancements, signal development, automation opportunities, and related RBQM analytical needs, including QTL approaches where aligned with CSM scope and portfolio priorities.
• Lead governance, documentation, inspection readiness, lifecycle management, and long-term sustainability of the CSM capability.
• Serve as a senior point of accountability for CSM-related questions, escalations, study team support, and cross-functional alignment.
• Lead, coach, and develop CSM statisticians and supporting resources. Direct line management responsibilities may be in scope depending on the final operating model.

Director, Centralized Statistical Monitoring

Financial Planning and Analysis

• Serve as a strategic partner to the VP General Manager of Rheumatology and Nephrology (Rare Disease) supporting development of the Business Unit vision and strategy, translating priorities into actionable plans, and enabling coordinated execution across the portfolio.
• Design and lead integrated BU governance processes, and support leadership engagements, business reviews that enable cross-brand alignment, strategic prioritization, and effective decision-making across brands and functions.
• Drive high-impact Business Unit initiatives, including capability building, portfolio resource optimization, and translation of enterprise priorities into actionable plans across the organization.
• Provide strategic recommendations to identify opportunities, address emerging challenges, and support Business Unit priorities.
• Lead cross-functional initiatives that advance objectives and strengthen organizational effectiveness.
• Ensure VP preparedness for key meetings, decisions, and engagements by proactively aligning stakeholders, managing follow-up actions, and developing high-quality executive communications and presentations.
• Help strengthen a collaborative, agile, and connected Business Unit culture through strong partnership, communication, and leadership engagement.
• Support design of and manage an agile Business Unit operating rhythm, including leadership team cadence, strategic planning, prioritization, and coordination of key meetings and strategic initiatives.
• Drive adoption and scaling of AI, technology, and innovative capabilities to enhance organizational effectiveness and business performance.
• Partner closely with BU leaders and cross-functional partners, including Finance, HR, and Data and Insights, to drive aligned decision-making and achievement of business objectives.
• Build and maintain strong, trusted relationships with leaders across key partners to enable successful, timely delivery of priorities.
• Represent the Business Unit in enterprise initiatives, governance forums, and cross-functional workstreams, as appropriate.
• Support organizational adherence to Compliance policies and procedures.
• Oversee Business Unit operational planning, budget management, and headcount tracking in close partnership with Finance and HR.
• Manage preparation and delivery of quarterly forecasting, long-range planning, and other performance management processes to support effective resource allocation and business decision-making.
• Ensure organizational compliance with company policies, procedures, and standards.

Strategic Planning & Operations Director – Rheumatology, Nephrology, Rare Disease

Account Manager

• Providing expert employee relations (ER) guidance and support to managers and staff in Amgen’s Operations function
• Work a hybrid schedule with a regular on-site presence a minimum of 3 days per week
• Partner with regional HR Leaders, Business Managers, Compliance, Legal, and other HR Centers of Excellence
• Protect Amgen values and investigate potential violations of HR policies
• Provide practical advice and guidance on performance and behaviors management, discipline, involuntary terminations, and workplace accommodations
• Conduct and document thorough, impartial, and timely HR investigations
• Prepare clear, concise investigation summaries and supporting documentation
• Partner with Occupational Health, Benefits, and staff to analyze and respond to reasonable accommodations
• Track and update cases in the company’s case management system
• Assist in implementing process improvements, training, and ER best practices

Staff Relations Manager

General

• Serve as a resource on patient access and reimbursement for infused and specialty therapies.
• Assist patients, caregivers, and healthcare providers in navigating insurance benefits, prior authorization requirements, and reimbursement processes.
• Support the identification and resolution of access challenges, including coverage questions, prior authorization barriers, and denied claims.
• Provide education regarding coding and billing considerations relevant to therapy access.
• Develop relationships with patients and caregivers through phone, virtual, and in-person engagement.
• Secure written or electronic patient HIPAA authorization within assigned geography.
• Assess individual patient needs and provide education and resources that support access to therapy.
• Educate patients on coverage considerations and the steps required to obtain prior authorization.
• Provide information regarding co-pay assistance programs, national foundations, and free drug programs when appropriate.
• Educate physician offices and sites of care on therapy coverage pathways and reimbursement processes.
• Provide information regarding common prior authorization requirements, coding considerations, and billing practices.
• Support healthcare providers and infusion centers in navigating reimbursement questions related to patient cases.
• Investigate patient access challenges before and after infusion.
• Support physician offices and sites of care in reviewing denied claims and identifying potential next steps.
• Escalate complex or systemic reimbursement issues to appropriate internal stakeholders.
• Partner with internal stakeholders including Market Access, Medical Affairs, Advocacy, Case Managers, and Site of Care teams to support patient access initiatives.
• Coordinate with internal and external partners to ensure appropriate resources are available to support patient access.
• Share field insights regarding payer policies and reimbursement challenges.
• Adhere to company policies, compliance guidance, and applicable to federal, state, and local regulations.
• Ensure activities align with HIPAA privacy requirements and internal compliance guidelines.
• Report adverse events and product complaints through established pharmacovigilance processes.
• Maintain accurate documentation of activities and interactions in Amgen’s internal system.

Patient Access Liaison – Rare Disease

Chief Marketing Officer

• Shape the brand strategy for the next phase post-launch in close collaboration with the full brand team, Brand Lead and cross-functional partners.
• Oversee the development of promotional tactics – work with market research and agency partners to uncover deep insights and translate them to compelling unbranded and branded marketing collateral.
• Manage the evolution of HCP messaging : Oversee the continuous improvement of unbranded and branded messaging and communications strategy to keep Lumakras at the forefront of the KRAS G12C inhibitor class.
• Peer to Peer strategy: Shape the peer-to-peer strategy and oversee seamless execution of the speaker bureau, including oversight of operations, and the evolution of speaker program content to align with LUMAKRAS' strategic goals.
• Collaborate with key partners including Sales leadership, MAC partners, Medical, Payer/Access, Corporate Communications, Operational teams, Global, and Commercial Data Analytics & Insight to uncover insights and to ensure connectivity on brand strategy, marketing and sales execution across customer stakeholders including HCPs and patients.
• Regularly engage with customers , including opinion leaders via conferences and individual interactions to gain real time input into marketing priorities and tactics.
• Partner with sales lead to ensure strategic and execution connectivity with the sales force.
• Regularly interface with the sales team to optimize performance, as well as troubleshoot and resolve execution barriers.
• Help train sales teams on marketing resources and strategy.
• Representation in organizational initiatives : Act as a representative in organizational-level initiatives designed to drive new capabilities and share best practices to more effectively reach and engage with HCPs.
• Compliance management : Manage internal legal, regulatory, and medical review and approval of materials to ensure responsible and compliant communications for LUMAKRAS.
• Budget management : Oversee budgets and closely monitor performance to meet brand goals and objectives, ensuring cost-effective delivery of all programs.
• Develop Team : Hire, retain, and successfully coach direct reports. Build and contribute to a team culture of dedication, accountability, and innovation, within the direct team, overall brand team, and cross-functional team members.
• Engagement with senior leadership : Present strategic and marketing plans to senior leadership and engage in ongoing performance reviews.

Commercial Director – LUMAKRAS Brand Marketing

Business Development Rep

• Serve as the primary integration point across Provider Contract Development and key partner functions, ensuring alignment of priorities, timelines, risks, and business objectives
• Lead governance forums, operating reviews, and renewal planning activities that support contract lifecycle visibility, stakeholder alignment, and execution readiness
• Coordinate cross-functional implementation activities and facilitate resolution of risks, dependencies, and execution barriers impacting provider contracting initiatives
• Develop and maintain reporting, dashboards, contract expiration tracking, renewal status reporting, and other tools that support organizational visibility and informed decision-making
• Provide leadership with actionable insights regarding renewal timelines, implementation progress, workload distribution, stakeholder readiness, and emerging risks
• Drive continuous improvement initiatives that enhance scalability, transparency, consistency, and operational effectiveness across Provider Contract Development
• Partner with CCFT and business stakeholders to advance workflow optimization, automation opportunities, reporting enhancements, and AI-enabled capabilities
• Build term sheets and complete request for proposals (RFPs) as needed to provide pricing offers to customers
• Maintain a comprehensive understanding of key customer’s financials, growth drivers, membership, mergers/acquisitions, end customers, etc
• Support ad-hoc requests by senior leadership for product and/or customer related needs
• Lead special projects and business process improvement initiatives that strengthen organizational effectiveness and operational maturity
• Support annual planning, prioritization, and resource discussions through reporting, analysis, and operational insights
• Champion effective communication, collaboration, and information sharing across stakeholders to support successful execution of provider contracting priorities