Amgen

Role Description The Clinical Pharmacology Modeling & Simulation Manager will be responsible for developing and implementing clinical pharmacology strategies to support drug development programs. The successful candidate will be the local representative of CPMS for the assigned programs and provide clinical pharmacology expertise to global and local teams. - Optimize clinical pharmacology components in local drug developments. - Collaborate with global and local cross-functional teams. - Apply clinical pharmacology principles and regulatory requirements to local drug development. - Effectively communicate clinical pharmacology results to internal and external stakeholders. - Contribute to regulatory submissions and interactions with PMDA. Qualifications - Strong knowledge of ADME and pharmacodynamics. - Familiarity with local regulatory documents in CTNs, J-NDAs, PMDA consultations. - Excellent communication and collaboration skills in both English and Japanese. - Ability to work independently and as part of a team. - At least 5 years of drug development experience with expertise in clinical pharmacology. - Experiences in regulatory interaction with PMDA, such as PMDA consultations and inspections. - Experiences of collaboration with global teams. - Master’s degree in pharmacology/pharmacokinetics or related scientific field. Requirements - Strong knowledge/experience in a disease area(s) of focus for Amgen, e.g., Inflammation, Cardiometabolic, rare disease, and Oncology. - PhD in pharmacology, pharmaceutical sciences, or a related field. - Knowledge/experience of electronic data submission for population pharmacokinetic/exposure-response analyses. - Knowledge/experience of managing external vendors.

Role Description 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. Responsibilities - 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 as well as 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. - Perform such other tasks and responsibilities as requested by the Company. Qualifications - Basic Qualifications (Account Manager – Level 4) - Bachelor's Degree and 3 years of sales experience within pharmaceutical, biotech or medical device industry or hospital sales experience - OR Associate degree and 6 years of sales experience within pharmaceutical, biotech or medical device industry or hospital sales experience - OR High school diploma/GED and 8 years of sales experience within pharmaceutical, biotech or medical device industry or hospital sales experience - Basic Qualifications (Specialty Account Manager – Level 5) - Doctorate degree & 2 years of collective account management experience, sales, & commercial experience - OR Master’s degree & 6 years of collective account management experience, sales, & commercial experience - OR Bachelor’s degree & 8 years of collective account management experience, sales, & commercial experience - OR Associate degree & 10 years of collective account management experience, sales, & commercial experience - Preferred Qualifications: - Buy-and-bill experience with documented success and/or biologic/infusion experience strongly preferred. - Sales experience in Endocrinology, Ophthalmology, and/or rare/specialty disease states preferred. - Site of care and reimbursement experience strongly preferred. - Experience working with institutions and integrated delivery networks preferred. - Pharma account management selling experience essential; must be able to coordinate across field teams to address full range of account needs. - Approximately 80% travel (may vary by territory), including some overnight and weekend commitments. - Proficient in Microsoft Office. - Professional, proactive demeanor. - Strong interpersonal skills. - Excellent written and verbal communication skills. Benefits - Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. - A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan. - Stock-based long-term incentives. - Award-winning time-off plans and bi-annual company-wide shutdowns. - Flexible work models, including remote work arrangements, where possible. Application Deadline Amgen's application deadline is 6/30 for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Equal Opportunity Employer Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

• Handling industry leading transformation of overall patient support offerings • Engaging directly with health care professionals and matrix partners to establish options for financial assistance / reimbursement • Making outbound calls to health care professionals (HCPs), when required • Entering data into supporting systems to initiate enrollment of new and existing patients • Reviewing Patient Enrollment Forms for completeness and accuracy, identifying any potential barriers and following all processes outlined in SOP • Initiating patient’s benefits verification by reviewing patient data and insurance material • Ensuring that data entry process into the supporting system is completed accurately and in a timely manner • Monitoring potential delays or pending cases

• Manage assigned end-to-end processes and ensure their readiness for execution of clinical supply chain processes. • Partner with DTI to assist with the resolution of technical incidents utilizing the Integrated Service Management-ServiceNow (ISM-SN) application. • Point of contact for application issues, incidents, and troubleshooting. • Manage timely closure of incidents. • Troubleshoot technical incidents with end users utilizing both internal resources and outside organizations such as External Trial Operations (ETO). • Monitor iDoc failures and determine the root cause of issues. • Work with the business and/or DTI team to implement corrective actions. • Act as a change record owner to support continuous improvement initiatives. • Manage documentation and maintenance of clinical customization requirements to support readiness for key projects, audits, and inspections. • Manage audit readiness playbooks for assigned processes. • Interpret customers’ needs to identify potential opportunities for improvements. • Generate Business Requirements (BRD) documents to initiate enhancements per the intake process. • Support development of business cases for proposed system enhancements. • Support and/or lead enhancement implementation. • Develop project milestones, adhere to timelines, utilize project management tools such as Smartsheet, communicate issues, ensure issue resolution, and ensure change management for business end users. • Act as primary tester for system enhancements and upgrades, which includes script authoring/approval, data preparation, test execution, and defect resolution test approval. • Support training in the clinical OTC and/or PTS process at Amgen to DSC and cross functional staff.

• Achieve results through detailed goal setting, accountability measures, effective partnership, performance management, collaboration with other groups, and dedication to serving customers • Independently lead sophisticated studies in the General Medicine therapeutic areas ensuring statistical aspects of clinical activities meet required standards and are robust and valid • Influence and supply to strategy development • Defend statistical approaches • Represent GBS through participating in and collaborating with multidisciplinary study teams

• In this vital role you will work in close partnership with the National Sales Director to achieve strong sales force delivery in alignment with Brand strategy. • This is primarily achieved by identifying unique performance and delivery trends as well as geo-specific opportunities, using data to fully characterize these as well as to assess progress over time. • The NBM enables enhanced focus for both the NSD as well as RSDs in terms of coaching, development, Opinion Leader engagement, etc. • Support NSD in aligning national direction with brand and corporate strategy. • Interpret data and trends within specific geographies in order to highlight specific brand performance opportunities. • Provide analytical support in identifying local business opportunities, assist in outlining tactics, and provide any critical metric support needed to assess progress. • Partner with SPO to suggest changes to analytic tools to simplify information to improve usage and effectiveness as needed. • Use analytics to see opportunities and create pull through strategies for new wins or changes in coverage. • Maximize Vision reporting tools to monitor pull-through progress and opportunities. • Monitor MMIT utilization and work to optimize delivery. • Monitor co-pay utilization and share relevant insights. • Partner with region leadership team to optimize RAS, vRAS, and OPM/RAS program deployment. • Actively investigate data and IC inquiries to help maintain credible compensation data. • Have direct conversations with the field on data questions and concerns. • Partner with NSD/SPO to ensure field understanding of the plan and develop strategy to demonstrate IC, special incentives, contests, as performance drivers. • Ensure region payouts are enhanced through periodic opportunity assessments and effective communication/motivation. • Partner with the NSD/SPO to develop a national engagement plan (Nation Calls, skip levels, leadership team calls, ACT III engagements, etc). • Partner with NSD/SPO to create any PowerPoint content and seek internal approvals (if required). • Serve as contact for x-functional partners such as FTM, RAS lead, VSP DM, as well as key OLs and Speakers in the Region. • May provide Interim District Manager coverage when there is a vacancy or leave. • Assist in recruiting and hiring process for the Nation. • Partner with SPO to gain expertise as regional expert in field processes including Veeva, Sampling, Speaker programs, Congresses, etc.

• own global QMS processes for Warehousing & Distribution (W&D) and Supply Chain Security (SCS), ensuring standardization and consistency across the network. • Define, maintain, and continuously improve global QMS processes for W&D and SCS, including standards, process flows, and documentation. • Assess and implement changes to processes to meet evolving regulatory, compliance, and business requirements. • Establish and manage process governance, including metric frameworks, performance tracking, and reporting. • Monitor process performance, analyze trends, and identify risks or gaps requiring corrective or preventive actions. • Lead and execute CI and OE initiatives across the GSC network. • Own and manage business systems supporting QMS processes (e.g., lane management, distribution complaints), including enhancements and lifecycle oversight. • Manage supplier-related processes for distribution materials to ensure quality, compliance, and performance standards are met. • Lead cross-functional collaboration to align processes and improve E2E performance. • Plan and support audits and MRs, ensuring processes meet quality expectations. • Drive change management activities related to process and system updates, ensuring adoption across regions and functions.

• support early-phase clinical development by translating scientific and clinical strategy into actionable execution across clinical trials • Provide hands-on oversight of protocol execution, medical data review, and clinical data quality to enable high-quality, decision-ready data • work collaboratively within cross-functional teams to ensure clinical trials are executed in alignment with protocol intent, regulatory expectations, and Amgen quality standards • Serve as a clinical and scientific subject-matter expert for the assigned therapeutic area and disease indication, with a strong focus on protocol execution and data integrity • Contribute to medical monitoring activities and support ongoing assessment of subject-level clinical data to identify trends, risks, and emerging issues • Present information internally and externally, anticipating and actively managing problems across a broad spectrum of cross-functional teams • Provide guidance and assistance in the identification and management of collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects • Work cross functionally to ensure clinical strategy is translated into the development of the study concept document, study protocol, and related documents • Ensure integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval • Provide clinical input into & implementation of clinical trial(s), delivery, clinical data review, and interpretation of results • Review and analyze clinical trial data to ensure accuracy, completeness, and adherence to protocol and regulatory requirements • Conduct thorough data quality assessments in the context of a data monitoring plan to maintain high standards of data accuracy and integrity throughout the trial lifecycle

• Lead a team of product managers who embed with priority products, product groups, and enterprise initiatives • Accelerate Amgen’s adoption of the Digital Product Operating Model (DPOM) • Help Amgen move from output-driven delivery to outcome-driven product management • Perform product management responsibilities while embedded with teams, including clarifying user and business problems, shaping product strategy, improving roadmaps, defining OKRs and KPIs • Support teams in developing strong product strategies, roadmaps, OKRs, KPIs, discovery practices, and value realization plans • Partner with business functions, digital product leadership, and technology leaders to align product work to enterprise priorities and measurable business value.

• Serve as the Business Partner Lead for Customer Engagement • Report directly to the Senior Director for Business Intelligence & Market Access • Lead category & sourcing teams across Data, Analytics, Market Research, Competitive Intelligence, Consent & Campaign Management, Market Access, Value & Pricing • Spearhead initiatives to define partnership strategies and oversee business planning and governance • Unlock innovation and value realization across Global Commercial Operations • Foster collaboration and champion change to position Global Procurement as a strategic value driver within the organization • Forge strategic, high-impact partnerships with key stakeholders across Global Commercial Operations • Leverage market intelligence to craft business strategies that connect with category objectives • Work strategically with the supply base to drive supplier-enabled innovation that supports business partner objectives • Collaborate with Finance and cross-functional teams to generate, capture, and recognize value across the pipeline • Influence budgetary decisions and profit-and-loss outcomes to maximize impact • Promote the adoption of Procurement-led and business-aligned strategic initiatives.