Amgen
Biotech company creating biologic medicines
Manager Data Support - Clinical Development
About the job
- A doctorate degree, or a master's degree and 2 years of clinical data management or clinical data operations experience, or a bachelor's degree and 4 years of such experience, or an associate's degree and 8 years of such experience, or a high school diploma/GED and 10 years of such experience.
- Understanding of clinical trial execution and how data management supports startup, conduct, and closeout.
- Experience managing and developing a team, including coaching, performance management, balancing, and delivering through competing priorities.
- Proficiency in Excel and familiarity with datasets, reconciliation logic, edit checks, and reporting or metrics.
- Ability to balance capacity, timelines, and shifting priorities across studies.
- Knowledge of right-first-time execution, documentation discipline, traceability, and adherence to standard operating procedures and work instructions.
- Ability to establish standard ways of working using templates, checklists, and playbooks.
- Ability to communicate with data delivery leads, program stakeholders, and resourcing partners and resolve conflicts.
- Understanding of edit checks, discrepancies, reconciliation, and external data flows.
- Ability to identify recurring issues such as backlogs, rework drivers, and error patterns and implement practical fixes.
- Ability to set expectations for responsiveness, handoffs, and asynchronous work across time zones.
- Recruit, onboard, and train new team members in partnership with training teams.
- Provide coaching, mentoring, and competency development for direct reports.
- Manage team risks including attrition, skill gaps, and performance challenges.
- Foster collaboration, accountability, clear communication, and continuous improvement.
- Partner with resourcing leads to assign associates based on skills, experience, and workload.
- Monitor capacity, forecast demand, raise gaps, and propose rebalancing plans.
- Ensure associates are prepared for study assignments, including access, training, expectations, and handoffs.
- Track allocation health and adjust proactively.
- Identify recurring gaps in skills, process adherence, or tooling and drive targeted training plans.
- Promote standard ways of working for associate execution.
- Capture lessons learned and share them across the support pool.
- Drive practical improvements that increase throughput and quality.
- Serve as the point of contact for escalations related to associate performance, responsiveness, and quality.
- Build relationships with study and program stakeholders to align expectations and resolve friction.
- Ensure consistent communication between delivery roles and the support pool regarding priorities and deadlines.
- Ensure associates operate within standard operating procedures, work instructions, and quality standards.
- Support audit and inspection readiness by ensuring evidence is complete, traceable, and appropriately stored.
- Partner with quality assurance and process leads to implement corrective actions.
- Monitor cycle time, error rates, rework, and backlog indicators.
- Support hiring coordination, allocation tracking, forecasting inputs, and reporting on team capacity, utilization, and skill coverage.
- At least 5 years in life sciences, including at least 3 years focused on clinical data management or clinical data operations supporting interventional trials.
- Experience leading teams that execute high-volume clinical data management work, including startup activities, data review and cleaning, reconciliation, and issue management.
- Experience supporting multiple studies or programs in parallel with shifting priorities.
- Prior experience in clinical data management, data operations, data capture, database build, or external data acquisition.
- Experience managing teams remotely or across time zones.
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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Professional Development Budget
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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.