Full-Time
Study Delivery Senior Associate
Updated on 8/13/2026
Amgen
10,001+ employees
Biotech company creating biologic medicines
No salary listed
Hyderabad, Telangana, India
In Person
Bachelor's, Master's, Associate's
 Biology & Biotech (1) |
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- 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.
- Expertise in clinical trial processes, operations, and oversight in biotechnology, 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, including accurate and timely data entry.
- Experience overseeing vendors and suppliers.
- Experience executing risk-based site monitoring, audits and inspections, Corrective and Preventive Action implementation, and risk mitigation.
- 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.
- Ability to recognize, highlight, and resolve issues, with curiosity and willingness to take on new tasks.
- 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.
- Monitor global enrollment, data flow, and quality indicators using study dashboards and reports, and take proactive action to address deviations and risks.
- Lead assigned risk and quality management activities.
- Track and report study progress, coordinating with study teams 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 relationships with internal study team members, vendors, and investigator sites.
- Act as a point of contact for routine study updates and keep stakeholders informed and aligned.
- Identify, prioritize, and escalate risks to support 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, and ensure 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 Action 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.
- Cultural sensitivity and collaboration across global teams.
- Understanding the importance of accuracy in documentation, data tracking, and compliance checks, including identifying discrepancies and escalating appropriately.
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
- Q2 2026 revenue hit $10.05 billion, and guidance rose to $38.2-$39.4 billion.
- Repatha sales jumped 37% in Q2 2026; Uplizna climbed 90%.
- MariTide Phase 3 programs are enrolling now, with obesity readouts expected in 2027.
What critics are saying
- FDA proposed Tavneos withdrawal on April 27, 2026 after data-integrity findings.
- July 2026 Amgen settled a $74 million IRS-disclosure suit; tax litigation continues.
- July 2026 layoffs hit Amgen again, signaling operating strain and portfolio pruning.
What makes Amgen unique
- Repatha, Uplizna, and Imdelltra diversified Amgen beyond Enbrel and Prolia.
- MariTide’s quarterly-or-sparser dosing targets obesity with lower treatment burden than weekly injectables.
- Amgen’s 2025-2026 launches span cardiology, oncology, and rare disease globally.
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Company News
Amgen's modeled fair value has risen from $352.23 to $371.93 per share following strong Q2 results and updated analyst targets. Several firms, including Scotiabank, TD Cowen, BMO Capital, and Oppenheimer, lifted price targets to around $450, citing earnings revisions and a diversified product portfolio. Bernstein noted a 6.8% revenue beat and 12.5% non-GAAP EPS beat in Q2, with raised full-year guidance driven by portfolio-wide execution. Strength came from products including Repatha, Tezspire, Uplizna, Evenity, and Imdelltra. However, Wells Fargo and Citi maintain cautious stances with Equal Weight and Neutral ratings, suggesting current performance may already be priced in. BofA kept its Underperform rating, describing 2026 as focused on execution ahead of key 2027 readouts.
Amgen reported second-quarter revenue of $10.05 billion, up 9% year on year, beating Wall Street expectations. Adjusted earnings reached $6.29 per share, surpassing the $5.62 consensus estimate. The biotech firm raised its full-year 2026 outlook, increasing expected revenue to $38.2 billion-$39.4 billion from $37.0 billion-$38.4 billion. Adjusted earnings guidance rose to $22.30-$23.50 per share. Repatha sales surged 37% to $953 million, whilst Evenity jumped 38% to $714 million. Rare-disease therapy Uplizna saw roughly 90% growth. These gains offset a 32% decline in Prolia sales due to biosimilar competition. Amgen discontinued obesity candidate AMG 513 but continues developing MariTide, with Phase 3 data expected in 2027. The stock trades at $406.17, approximately 14.75% above its estimated fair value.
Amgen reported second quarter 2026 revenues of $10.1 billion, a 10% increase year-over-year. Product sales grew 9%, driven by volume growth across 22 products that achieved double-digit sales growth. The company's six key growth drivers grew 26% year-over-year, generating nearly 70% of second quarter product sales. GAAP earnings per share increased 65% to $4.37, whilst non-GAAP EPS rose 4% to $6.29. Notable product performance included Repatha sales increasing 37% to $953 million and EVENITY growing 38% to $714 million. The company generated $3.5 billion in free cash flow, compared to $1.9 billion in the prior year period. For full year 2026, Amgen expects total revenues between $38.2 billion and $39.4 billion, with non-GAAP EPS guidance of $22.30 to $23.50.
Amgen secured a preliminary injunction in early June 2026 blocking Colorado's proposed 70% price cap on Enbrel, its rheumatoid arthritis drug. The federal judge's decision preserves pricing flexibility for the legacy asset. However, the company initiated several voluntary Class II recalls of Corlanor and Sensipar batches in the US due to foreign substances and manufacturing deviations. While not yet financially material, the recalls highlight ongoing operational risks. Amgen's investment case depends on its diversified portfolio offsetting pricing pressure and biosimilar competition. The company projects revenue of $40.1 billion and earnings of $9.9 billion by 2029, requiring 2.5% annual revenue growth. Current 2026 guidance stands at $37.1–$38.5 billion in revenue. The combination of pricing relief and quality concerns presents investors with a rebalanced risk-reward profile for the biotech company.
The New England Journal of Medicine has retracted the 2021 clinical trial that supported approval of Amgen's Tavneos, a treatment for ANCA-associated vasculitis that generated $459 million in sales last year. The retraction followed an FDA investigation revealing that results from nine patients were altered after the study database was finalised, whilst some researchers had been unblinded. The FDA alleges the original data showed no statistically significant difference between Tavneos and existing treatments, but subsequent changes made the drug appear more effective. The agency proposed withdrawing Tavneos from the US market in April, whilst European regulators have also recommended removal. Amgen, which acquired ChemoCentryx for $3.7 billion in 2022, continues selling Tavneos and has requested an FDA hearing. The company says it is engaging independent researchers to reanalyse the data.