Full-Time
Study Delivery Senior Associate
Updated on 5/14/2026
Amgen
10,001+ employees
Biotech company creating biologic medicines
No salary listed
Hyderabad, Telangana, India
In Person
 Biology & Biotech (1) |
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- Master’s degree
- Bachelor’s degree and 2 years of clinical execution experience
- Associate’s degree and 6 years of clinical execution experience
- High school diploma / GED and 8 years of clinical execution experience
- Lead the development and maintenance of study-level trackers, dashboards, timelines, and tools (e.g., vendor management, sample tracking, drug supply planning) to ensure accuracy and visibility.
- Coordinate logístics for investigator meetings, trial events, and site communications.
- Manage assigned start-up activities, including system setup, access management, and document readiness, ensuring completion to required standards.
- 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 Study team and vendors to resolve operational issues and maintain compliance.
- Deliver assigned components of global recruitment and retention strategies to help ensure enrollment targets are achieved.
- 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 effectively to support swift, informed decisions.
- Lead vendors and supplier setup to ensure quality, speed, and consistency in deliverables.
- Maintain and monitor clinical trial systems (e.g., CTMS), ensuring accurate and timely data entry and reporting.
- Support data collection oversight, including query resolution and reconciliation activities.
- Manage trial documentation (e.g., Trial Master File) to ensure inspection readiness.
- Contribute to best practice development, knowledge-sharing and process improvement within the study support community.
- Proactively identify and highlight opportunities to streamline / automate activities within remit.
- Support Audit/Inspections including Corrective and Preventive Actions (CAPA) processes and embed lessons learned across studies.
- 3 years’ work experience in life sciences or medically related field, including 1 year of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or Contract Research Organization company
- Experience working on global clinical trials
- Strong collaborative and effective communication skills within a team environment
- Understands importance of accuracy in documentation, data tracking, and compliance checks; identifies discrepancies and escalates appropriately
- Expertise in clinical trial processes, operations, and oversight in biotech, pharmaceutical, or Contract Research Organization environments
- Strong skills in using MS Word, Excel, PowerPoint, and other relevant software for documentation, data management, and trial support
- Working knowledge of CTMS, eTMF, EDC, and Microsoft Office tools. Ability to maintain accurate and timely data entry. Skilled in managing clinical trial data flow, investigator documentation, and protocol adherence while ensuring regulatory compliance
- Experience with overseeing vendors and suppliers
- Experience executing risk-based site monitoring, Audit and Inspections CAPA implementation, and risk mitigation to resolve operational challenges and ensure inspection readiness
- Cultural sensitivity and collaboration across global teams
- Ability to recognize, highlight and resolve issues. Demonstrates curiosity and willingness to take on new tasks
- Understanding of the clinical and pharmaceutical drug development process and clinical trial execution principles
- Experience with tracking and filing of essential documents such as protocols, informed consent forms, and regulatory submissions to ensure documents are version-controlled and inspection-ready
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
Simplify's Take
What believers are saying
- Tarlatamab wins China NMPA approval May 2026 for $2B+ sales potential.
- Q1 2026 revenues hit $8.6B with 16 brands posting double-digit growth.
- Zai Lab partners on DLL3-ADC plus IMDELLTRA for SCLC trials.
What critics are saying
- Prolia sales drop 34% to $727M from biosimilar competition in Q1 2026.
- FDA warns Tavneos causes liver injuries, proposes approval withdrawal.
- Horizon drugs Tepezza, Uplizna, Krystexxa underperform 19 months post-acquisition.
What makes Amgen unique
- Amgen's BiTE platform establishes IMDELLTRA as second-line SCLC standard.
- MariTide advances in Phase III obesity trials with monthly dosing.
- UPLIZNA surges 73% post-IgG4 and gMG approvals in 2025.
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Company News
Amgen's lung cancer drug tarlatamab has received approval from China's National Medical Products Administration, according to its development partner BeOne Medicines. The drug is a targeted immunotherapy for adults with extensive-stage small cell lung cancer that has progressed despite chemotherapy. Sold as Imdelltra in the US, tarlatamab is a bispecific antibody designed to connect cancer cells with immune cells, enabling the body's immune system to destroy the cancer. Neither Amgen nor Hong Kong-listed BeOne provided details on launch date or pricing for the Chinese market. Wall Street analysts estimate tarlatamab could generate annual sales exceeding $2 billion for Amgen.
Amgen faces fresh safety concerns after the FDA warned of severe liver injuries, including vanishing bile duct syndrome, linked to Tavneos (avacopan) in late March 2026. The development adds regulatory risk to the company's investment profile. Separately, Zai Lab announced a global collaboration with Amgen to test its DLL3-targeting ADC alongside Amgen's IMDELLTRA in extensive-stage small cell lung cancer, underscoring the company's ongoing oncology expansion through external partnerships. Amgen's narrative projects $37.4 billion revenue and $8.2 billion earnings by 2028, requiring 2.3% yearly revenue growth. However, pessimistic analysts model revenues slipping to $34.4 billion with earnings near $5.2 billion, reflecting concerns around pricing pressure, biosimilar competition and rising research and development spend alongside the new safety issues.
Amgen, one of the world's largest pharmaceutical companies, has seen its shares rise 24% since Jim Cramer discussed the stock on Mad Money in June 2025. The company is currently developing the weight loss drug MariTide. Amgen's shares jumped 7.5% in November 2025 after posting third-quarter results that beat analyst expectations, with $9.6 billion in revenue and $5.64 earnings per share against forecasts of $8.98 billion and $5.04 respectively. In February 2026, shares rose 8% following fourth-quarter earnings that also exceeded estimates. Cramer expressed cautious optimism about the biotech company, noting its mid-single-digit earnings growth and potential upside from its GLP-1 drug development. Whilst calling Eli Lilly his preferred GLP-1 play, Cramer said investors "could do a lot worse than Amgen" for a bargain option.
Wells Fargo has raised its price target on Amgen to $390 from $375, maintaining an Equal Weight rating. The firm cited emerging therapies including CD20, BAFF/APRIL and next-generation complement inhibitors as potential drivers that could expand the generalized myasthenia gravis market threefold over the next decade, potentially reaching $15 billion in US sales and $20 billion globally by 2036. Separately, Jefferies initiated coverage on Amgen with a Hold rating and $350 price target on 10 March, noting the stock has gained approximately 35% over the past six months. Last month, Amgen reported fourth-quarter adjusted earnings per share of $5.29, beating the $4.76 consensus estimate, on revenue of $9.9 billion versus $9.45 billion expected.
Amgen has announced a $2.52 per-share second-quarter dividend and joined the government-run TrumpRx platform to offer discounted drugs including Amjevita, Aimovig and Repatha. The company is also preparing for its 11 March presentation at the Leerink Global Healthcare Conference in Miami. The moves come alongside double-digit revenue and earnings per share growth in 2025 and advances in obesity and oncology programmes. However, the TrumpRx discounting could pressure net pricing as Amgen invests heavily in late-stage trials and manufacturing expansion. Amgen's narrative projects $37.4 billion revenue and $8.2 billion earnings by 2028, requiring 2.3% yearly revenue growth. Some analysts see a tougher outlook, with revenue potentially drifting towards $34.4 billion and earnings around $5.2 billion.