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Amgen is a leading independent biotechnology company focused on developing innovative human therapeutics to address serious illnesses. Founded in 1980, Amgen leverages advanced human genetics and biologics manufacturing expertise to improve health outcomes and enhance the quality of life for patients worldwide.

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Jobs at this company:

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🔥 Senior Director, Biostatistics

Posted 4 days ago

📍 United States

💸 239497.0 - 271577.0 USD per year

🔍 Biotechnology

🔧 Requirements

Doctorate degree and 5 years of related experience of post-graduate statistical experience in the pharmaceutical industry or medical research OR Master’s degree and 9 years of related experience of post-graduate statistical experience in the pharmaceutical industry or medical research OR Bachelor’s degree and 11 years of related experience of post-graduate statistical experience in the pharmaceutical industry or medical research
5 years of experience directly managing people and/or leading teams, projects, or programs, in Statistics/Biostatistics
statistical leadership to regulatory submissions, including advisory committees
Demonstrated ability to work within a global team and with CRO partners to ensure operational excellence and efficiencies
Life cycle Drug development experience (Pre-clinical Development, Clinical Development, and Post-marketing), hence knowledgeable of the processes and operations
Knowledge/experience of Biosimilars development, including global regulatory requirements and design and analysis of non-inferiority and equivalence trials

💡 Responsibilities

Provide oversight for protocols, Statistical Analysis Plans, Flash Memos/Summary of Report, Clinical Study Reports, submission documents, correspondences with health authorities, clinical publications, reimbursement documents and other communications.
Develops and maintains successful application of statistical excellence in design, analysis, and reporting to all phases of biosimilar development.
Provides strategic statistical input and is a major contributor to clinical development plans.
Ensures standards, technical quality and consistent approaches in clinical development strategy, study design and statistical analysis; maintains indication specific standards with respect to key variables, variable definitions, statistical methods, data structures and presentation of results; and contributes to statistical strategy in Amgen's Biosimilar Development.
Ensures excellent statistical input into regulatory strategies, presentations and scientific reports for clinical trial, regulatory submission, product defense, market support, scientific presentation/publication.
Represents Biosimilar Development on statistical matters at meetings with regulatory authorities, key opinion leaders and similar other expert bodies and defends statistical approaches internally and externally.
Provides oversight and guidance to staff members within Amgen and in CROs in completing study deliverables according to agreed timelines following quality standards.
Responsible for hiring, allocation, management, and development of internal statistical staff, and contributes to developing and managing goals, budgets and resource plans.
Leads and/or participates in the development and review of Policies, SOPs and other controlled documents with CROs or within Amgen's Biosimilar Development for process improvement and operational efficiency.
Promotes, communicates, and becomes an expert in specific statistical methodologies.
Publishes applied research in scientific journals and books and gives presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings.
Stays abreast of and contributes to scientific advances in the field.
Develops and maintains long-term relationships with key statistical opinion leaders, including academics, regulators and other industry leaders.

LeadershipData AnalysisPeople ManagementSAS EGData StructuresRDBMS

Posted 4 days ago

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🔥 Value & Access Senior Manager, Cardiovascular

Posted 4 days ago

📍 United States of America

💸 167333.0 - 197262.0 USD per year

🔍 Value and Access

🔧 Requirements

Doctorate degree and 2 years of health economics, public health, epidemiology, pharmacy, life sciences or related field/relevant experience
Master’s degree and 4 years of health economics, public health, epidemiology, pharmacy, life sciences or related field/relevant experience
Bachelor’s degree and 6 years of health economics, public health, epidemiology, pharmacy, life sciences or related field/relevant experience
Associate’s degree and 10 years of health economics, public health, epidemiology, pharmacy, life sciences or related field/relevant experience
High school diploma / GED and 12 years of health economics, public health, epidemiology, pharmacy, life sciences or related field/relevant experience
Launch experience, preferably in the Cardiovascular space
Strong understanding of the US payer environment, preferably combined with in-country work experience
Strong understanding of the payer environment in major ex-US countries, including coverage and reimbursement, pricing, health technology assessment, and healthcare policy
Ability to review clinical and health economic literature, including disease state information, clinical trial design and results, and pharmacoeconomic studies, in order to understand implications for value to payers
Ability to translate complex situations and pricing analyses into clear conclusions and to effectively communicate impact to Amgen business
Ability to plan strategically, identify strategic options and trade-offs
Demonstrated ability to work in a highly fluid, interactive, matrixed environment and build strong, successful business partnerships with affiliate and global colleagues
Strong analytical skills and advanced proficiency in Microsoft Excel
Strong prioritization and project management skills
Strong oral/written presentation and communication skills

💡 Responsibilities

Support global launch planning activities for Olpasiran for the top 10 markets including development of access materials for affiliates, such as the Integrated Access Strategy, Global Value Story and Objection Handler, pricing guidance materials, negotiation frameworks etc.
Run and facilitate the Olpasiran Global Access Team forum and ensure best practice sharing across top 10 markets and insights gathering to inform access, pricing and payer evidence strategy refinement for the asset
Support the development and governance process of the Global Pricing Policy
Support forecast / LRS for LCM indications and review top 10 markets pricing/access assumptions
With the ASL, conduct situation analysis and payer/pricing research of external pricing and reimbursement environment regarding different Olpasiran LCM indications, and synthesize relevant information to develop strategic recommendations for the Product Team
Support franchise level initiatives to develop the cardiovascular market and optimize Amgen’s cardiovascular business, with a focus on payers & policy makers

Project ManagementData AnalysisCommunication SkillsAnalytical SkillsMicrosoft ExcelNegotiationCross-functional collaborationMarket ResearchData visualizationStrategic thinkingFinancial analysis

Posted 4 days ago

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🔥 Senior Web Solutions Architect

Posted 6 days ago

📍 United States of America

💸 154142.0 - 182371.0 USD per year

🔍 Information Systems

🔧 Requirements

Prior experience running large scale web platforms ideally with Adobe Experience Platform or Sitecore (Sitecore XM Cloud, Sitecore XP), and AWS (Amazon Web Services) Cloud technologies.
Ability to think strategically about technology and recommend solutions that align with business strategy and achieve the greatest business impact.
Prior experience crafting and implementing continuous delivery and/or DevOps solutions or architecture patterns with focus on automated delivery and release of web applications.
Experience using at least one scripting language like Python and repository/versioning tools such as GitHub.
Hands-on experience with .NET, SQL, APIs (Mulesoft), and Generative AI Tools
Deep understanding of Agile and Lean Startup principles.
Excellent verbal communication skills, interpersonal and decision-making skills.
Exposure to the complete product development lifecycle (using SAFe)—from requirements to integration and testing.
Familiarity with digital healthcare IT (Information Technology) strategies and trends.
Thriving in a very dynamic environment, with adaptability a must to new situations and business needs.

💡 Responsibilities

Understanding how business requirements, information, and systems are translated into solution architecture and design.
Actively drive the transformation of the MarTech stack, with an emphasis on the content management system and server-side tagging.
Defining architecture and technical roadmaps for the entire web ecosystem including websites/portals and other web assets with a focus on de-coupled systems.
Hands-on development of reusable components, templates, code, and libraries.
Being responsible for the creation of automation, and DevOps capabilities to ensure continuous, fast, and quality product launches.
Taking accountability for identifying and mitigating architectural risks.
Monitoring and improving our infrastructure investment to ‘right match’ our development, performance, and security needs.
Evaluating technical solutions and ensuring alignment with Amgen’s Enterprise Architecture standards (“Amgen City Planning”).
Communicating effectively with individuals and teams across a large organization.
Utilizing AI to enhance web platform efficiency, and to improve productivity.

AWSDockerPythonSQLAdobe Creative SuiteAgileArtificial IntelligenceBashCloud ComputingFrontend DevelopmentHTMLCSSJavascriptJenkinsSoftware ArchitectureActiveMQAPI testingContent management.NETCI/CDRESTful APIsDevOpsMicroservices

Posted 6 days ago

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🔥 Clinical Research Medical Sr. Director, Thoracic Oncology

Posted 7 days ago

📍 United States of America

🧭 Full-Time

💸 288166.0 - 362695.0 USD per year

🔍 Biopharmaceutical

🔧 Requirements

MD or DO degree from an accredited medical school
5 years of clinical research and/or basic science research experience
5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

💡 Responsibilities

Provide therapeutic area expertise in thoracic oncology and drive development, execution, and communication of the global scientific/medical evidence plan for small cell lung cancer area, including leading the evidence generation team.
Serve as global development lead for specific small cell lung cancer indications and/or patient impact expansion (PIE) strategies.
Manage a clinical development team of clinical research medical directors and medical science directors

LeadershipProject ManagementData AnalysisPeople ManagementCross-functional Team LeadershipCommunication SkillsReportingTeam managementStakeholder managementStrategic thinking

Posted 7 days ago

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🔥 Clinical Data Manager (US-Remote)

Posted 7 days ago

📍 United States

💸 121739.0 - 143337.0 USD per year

🔍 Pharmaceutical

🔧 Requirements

Clinical Data, Project and Planning Management experience in the Pharmaceutical or Biotech industry.
Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, etc.).

💡 Responsibilities

Project level coordination of and day to day oversight of DM tasks including: Review all DM documents within a project area to ensure a consistent approach and review of project timelines and metrics to ensure databases are delivered to set timelines, and approve database locks and unlocks.
Ensure that quality control checks are occurring such that quality databases are delivered.
Develop and coordinate project level training for data management staff.
Review and approve study specific training and lead vendor results and relationship at the project level.
Communication of project level issues including processes, timelines, resourcing, performance, etc.
Review of all study level non-DM documents for awareness and project level consistency.
Lead electronic submission activities and assist with response to questions and findings from Clinical Quality Assurance (Quality Assurance) and other audits at the study / vendor level.
Lead or participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting DM.

Project ManagementQAProject CoordinationComplianceData management

Posted 7 days ago

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🔥 Senior Associate Paralegal - Preclinical Contracting

Posted 13 days ago

📍 United States

💸 111234.0 - 131770.0 USD per year

🔍 Law/Legal

🔧 Requirements

Completion of an ABA-approved paralegal education program or equivalent experience
Experience working as a paralegal in a corporate legal department or law firm environment
Strong knowledge of contracting and legal procedures, particularly related to pharmaceutical and/or university contracts
Proficiency in MS Word, MS Excel, MS PowerPoint, and Docusign, and as well as familiarity with evolving technologies such as AI technologies and machine learning
Excellent organizational skills, with the ability to manage multiple tasks and prioritize deadlines effectively

💡 Responsibilities

Provide legal support on a wide array of preclinical contracting issues
Perform research on laws, regulations, and industry developments affecting preclinical contracting issues
Drafting and negotiating a high volume of preclinical-related and translational contracts in a time-sensitive environment

NegotiationAttention to detailOrganizational skillsWritten communicationComplianceVerbal communication

Posted 13 days ago

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