Amgen
Biotech company creating biologic medicines
Study Delivery Senior Associate
About the job
- A master’s degree, or a bachelor’s degree and 2 years of clinical execution experience, or an associate’s degree and 6 years of clinical execution experience, or a high school diploma/GED and 8 years of clinical execution experience.
- Strong collaborative and effective communication skills within a team environment.
- Accuracy in documentation, data tracking, and compliance checks, including identifying discrepancies and escalating them appropriately.
- Expertise in clinical trial processes, operations, and oversight in biotech, pharmaceutical, or Contract Research Organization environments.
- Strong skills using Microsoft Word, Excel, PowerPoint, and other relevant software for documentation, data management, and trial support.
- Working knowledge of Clinical Trial Management Systems, electronic Trial Master Files, Electronic Data Capture, and Microsoft Office tools.
- Ability to maintain accurate and timely data entry and manage clinical trial data flow, investigator documentation, protocol adherence, and regulatory compliance.
- Experience overseeing vendors and suppliers.
- Experience executing risk-based site monitoring, implementing Audit and Inspections Corrective and Preventive Actions, and applying risk mitigation to resolve operational challenges and ensure inspection readiness.
- Cultural sensitivity and ability to collaborate across global teams.
- Ability to recognize, highlight, and resolve issues, with curiosity and willingness to take on new tasks.
- Understanding of the clinical and pharmaceutical drug development process and clinical trial execution principles.
- Experience tracking and filing essential documents such as protocols, informed consent forms, and regulatory submissions to ensure version control and inspection readiness.
- Lead the development and maintenance of study-level trackers, dashboards, timelines, and tools, including vendor management, sample tracking, and drug supply planning.
- Coordinate logistics for investigator meetings, trial events, and site communications.
- Manage assigned study start-up activities, including system setup, access management, and document readiness.
- Use study dashboards and reports to monitor global enrollment, data flow, and quality indicators, taking proactive action to address deviations and risks.
- Lead delivery of assigned risk and quality management activities.
- Track and report study progress, coordinating with the study team and vendors to resolve operational issues and maintain compliance.
- Deliver assigned components of global recruitment and retention strategies to help achieve enrollment targets.
- Manage Study Training system activities and oversight.
- Build and maintain effective relationships with internal study team members, vendors, and investigator sites.
- Act as a point of contact for routine study updates, ensuring stakeholders are informed and aligned.
- Identify, prioritize, and escalate risks to support swift, informed decisions.
- Lead vendor and supplier setup to ensure quality, speed, and consistency in deliverables.
- Maintain and monitor clinical trial systems, including Clinical Trial Management Systems, ensuring accurate and timely data entry and reporting.
- Support data collection oversight, including query resolution and reconciliation activities.
- Manage trial documentation, including Trial Master Files, to ensure inspection readiness.
- Contribute to best-practice development, knowledge sharing, and process improvement within the study support community.
- Identify and highlight opportunities to streamline or automate activities within the role’s remit.
- Support audits and inspections, including Corrective and Preventive Actions processes, and embed lessons learned across studies.
- Three years of work experience in a life sciences or medically related field, including one year of biopharmaceutical clinical research experience working on clinical trials in a biotechnology, pharmaceutical, or Contract Research Organization company.
- Experience working on global clinical trials.
About the company
Amgen develops medicines that treat serious illnesses by using biologic therapies made from living cells. These therapies are designed to target specific disease processes, such as cancer, cardiovascular disease, and autoimmune conditions, and are produced through biotechnology methods that create proteins or antibodies. Amgen’s products are sold to patients and healthcare providers worldwide, with revenue funding ongoing research and development to discover new treatments. The company stands out by focusing on biologic medicines at a large scale and maintaining a steady pipeline of potential therapies across multiple disease areas, supported by global manufacturing and a commitment to bringing therapies to patients. Its goal is to improve patient outcomes by discovering and delivering new, effective treatments while reinvesting a significant portion of earnings into research and development.
Company Size
10,001+
Company Stage
IPO
Headquarters
Thousand Oaks, California
Founded
1980
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Simplify's Take
What believers are saying
- Amgen raised 2026 revenue guidance to $38.2 billion-$39.4 billion after Q2 outperformance.
- Repatha sales jumped 37% to $953 million, driven by cardiologist and primary-care adoption.
- MariTide now has nine ongoing and three planned Phase 3 studies across obesity.
What critics are saying
- Prolia and XGEVA sales fell 33% in Q2 2026 as biosimilars hit.
- FDA proposed withdrawing TAVNEOS in April 2026, threatening a marketed rare-disease franchise.
- If MariTide misses 2027 endpoints, Amgen loses its next obesity growth pillar.
What makes Amgen unique
- Amgen's six growth drivers produced nearly 70% of Q2 2026 product sales.
- IMDELLTRA sales rose 115% in Q2 2026, validating Amgen's oncology engine.
- Hyderabad's 2027 Science and Innovation Center expands Amgen's seven-lab global R&D network.
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Company News
Revolution Medicines received FDA approval for daraxonrasib, the first targeted therapy for metastatic pancreatic cancer, after clinical data showed it reduced death risk by more than half. The company is clinical-stage with no current revenue and posted a $1.1 billion net loss in FY 2025. Amgen reported FY 2025 revenue of $36.7 billion, up 9.9% year-over-year, with net income of $7.7 billion and a 21% net margin. Free cash flow reached $8.1 billion. The company carries a debt-to-equity ratio of 6.3x. Revolution Medicines maintains a 0.1x debt-to-equity ratio and 9.5x current ratio but recorded negative free cash flow of $913.7 million. The company's pipeline targets RAS-driven tumours including lung cancer. A partnership with Royalty Pharma provides funding for development. Both companies face distinct risks: Amgen confronts pricing pressures and biosimilar competition, whilst Revolution Medicines carries clinical trial failure risks and competes against larger pharmaceutical firms.
Amgen reported revenue of $36.7 billion in FY 2025, up 9.9% year-over-year, with net income of $7.7 billion and a 21% net margin. The biotech giant maintains a debt-to-equity ratio of 6.3x and generated $8.1 billion in free cash flow. CRISPR Therapeutics, meanwhile, saw revenue fall 90% to $3.5 million in FY 2025, posting a net loss of $581.6 million. The gene-editing firm burns $345.9 million in cash but holds a strong current ratio of 13.3x. Its CASGEVY therapy for sickle cell disease has gained approval in the US, UK, and EU, with Vertex handling commercialisation under a 60-40 revenue split. Amgen faces pricing pressure from the Inflation Reduction Act and biosimilar competition. CRISPR Therapeutics carries clinical execution risk and ongoing intellectual property disputes.
Amgen and AstraZeneca announced positive results from the phase III DeLLphi-305 study evaluating Amgen's Imdelltra (tarlatamab) combined with AstraZeneca's Imfinzi (durvalumab) as first-line maintenance treatment for extensive-stage small-cell lung cancer (ES-SCLC). The study met its primary endpoint of overall survival and key secondary endpoint of progression-free survival, with no new safety concerns identified. ES-SCLC affects approximately 195,000 people globally. If approved, the combination would compete with Jazz Pharmaceuticals' Zepzelca plus Roche's Tecentriq, which received FDA approval in October 2025. Imdelltra, approved in 2024 for ES-SCLC progression after platinum-based chemotherapy, generated $546 million in global sales during the first half of 2026, up from $215 million in the prior-year period.
Amgen reported FY 2025 revenue of $36.7 billion, up 9.9% year-over-year, with net income of $7.7 billion and a 21% net margin. The biotech serves 17 million patients globally with treatments for heart disease, obesity, and cancer. However, three distributors—McKesson, Cencora, and Cardinal Health—accounted for 77% of gross revenues, creating concentration risk. The company's debt-to-equity ratio stood at 6.3x. Moderna posted FY 2025 revenue of $1.9 billion, down 39.2% as pandemic-related vaccine demand declined. The mRNA specialist reported a net loss of $2.8 billion, resulting in a negative 145.2% net margin due to high research and development costs. The company is pivoting its mRNA platform toward infectious diseases, cancer, and rare conditions whilst expanding through partnerships like its collaboration with Merck.
Amgen trades at $393 per share, representing a trailing multiple of 23.3 times adjusted earnings. The biotech faces declining sales from Prolia and XGEVA, down 33% year-over-year to $1.1 billion in Q2 2026, due to biosimilar competition. Six key growth medicines grew 26% year-over-year, accounting for nearly 70% of Q2 product sales. Analysts forecast the forward multiple at 17.0 times for fiscal 2026 and 16.1 times for 2027. However, consensus assumes expanding profit margins whilst Amgen increases spending. Non-GAAP research spending is set to grow in high single digits for 2026, funding nine Phase III trials for MariTide, its obesity treatment candidate. Management warned of meaningful operating expense increases in Q3 2026. The valuation depends on margin expansion materialising during this investment phase.