Full-Time
Senior Manager, Database Design
Updated on 8/3/2026
Amgen
10,001+ employees
Biotech company creating biologic medicines
No salary listed
Hyderabad, Telangana, India
In Person
 Biology & Biotech (1) |
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- Doctorate degree and 8 years of relevant experience; or master's degree and 10 years of relevant experience; or bachelor's degree and 12 years of relevant experience.
- Minimum 3 years of people leadership or resource management experience.
- Experience with Vault Clinical Data Management System, Medidata Rave, or similar electronic data capture platforms.
- Operational leadership and execution expertise in clinical database design and portfolio delivery.
- Strong understanding of database lifecycle management, validation, and governance processes.
- Ability to drive enterprise-level standardization and operational scalability.
- Expertise in metadata-driven design, interoperability, and analytics-ready data solutions.
- Strong risk identification, escalation, and mitigation capabilities.
- Executive communication and stakeholder management skills.
- Ability to lead organizational changes, innovation, and continuous improvement initiatives.
- Strong people leadership, mentoring, and talent development capabilities.
- Strong execution orientation combined with strategic thinking.
- Lead execution of database design strategy across multiple studies and programs.
- Lead, coach, and develop direct reports through performance management and succession planning.
- Drive workforce planning and resource allocation across programs.
- Ensure adoption of standardized clinical report form design, edit checks, workflows, and metadata-driven design practices.
- Provide oversight of database build activities in Vault Clinical Data Management System, Medidata Rave, and related electronic data capture systems.
- Establish reusable libraries, automation frameworks, and standards-based database design approaches.
- Ensure alignment of database configurations with protocol requirements, Clinical Data Interchange Standards Consortium standards, and downstream analytics needs.
- Lead governance processes and resolve complex database design issues.
- Partner with cross-functional stakeholders and vendors to ensure seamless integration of clinical report form and non-clinical-report-form data.
- Drive implementation of automation, artificial intelligence-enabled validation, and metadata-driven design initiatives.
- Monitor database delivery metrics, validation status, user acceptance testing outcomes, and study readiness.
- Ensure compliance with Good Clinical Practice, standard operating procedures, validation standards, and regulatory expectations.
- Lead continuous improvement initiatives focused on quality, efficiency, and scalability.
- Operationalize governance processes and participate in cross-functional decision-making forums to resolve complex study and program-level database design issues.
- Ensure database configurations align with protocol requirements, Clinical Data Interchange Standards Consortium and Standardized Study Data Tabulation Model standards, downstream analytics requirements, and enterprise data strategy.
- Support resource forecasting, workload prioritization, and operational planning across database design activities.
- Mentor and develop Senior Clinical Database Designers and Clinical Database Designers while establishing performance expectations and development plans.
- Provide program-level leadership and accountability for database design delivery across multiple studies and programs.
- Lead and mentor database design teams, driving standardization, quality, innovation, and operational excellence across the portfolio.
- Build and maintain a high-performing database design organization through coaching, engagement, and talent development.
- Serve as the operational database design leader across assigned portfolios, contributing to enterprise standards, governance discussions, and modernization initiatives.
- Ensure delivery of compliant, validated, interoperable, and analytics-ready databases aligned with organizational and regulatory expectations.
- Drive operational efficiencies through automation, reusable standards, and metadata-driven design methodologies.
- Approve database standards, reusable libraries, and governance processes.
- Allocate and direct database design resources across studies and programs.
- Approve talent development plans, performance objectives, and workforce allocation decisions.
- Escalate and resolve program-level database design risks and operational issues.
- Approve database design performance expectations and operational priorities.
- Drive modernization initiatives and implementation of automation strategies.
- 13+ years of clinical research, clinical data management, or database design experience.
- Strong expertise in metadata-driven database design and clinical data architecture.
- Experience leading global database design delivery across complex portfolios.
- Strong understanding of Clinical Data Interchange Standards Consortium, Standardized Study Data Tabulation Model, Risk-Based Quality Management, and clinical data standards.
- Experience managing external vendors and global delivery models.
- Demonstrated experience driving modernization, automation, and digital transformation initiatives.
- Experience supporting inspection readiness and regulatory audits.
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
- A broad pipeline targets heart disease, obesity, rare disease, inflammation, and cancer.
- Global reach across roughly 100 countries supports scale and diversification.
- Legacy cash flows from mature biologics fund new medicine development.
What critics are saying
- Enbrel faces pricing pressure after Colorado's 70% price-cap challenge.
- Recent Corlanor and Sensipar recalls expose manufacturing and quality-control weaknesses.
- Biosimilar competition threatens mature biologics and compresses future margins.
What makes Amgen unique
- Amgen combines biologics discovery, manufacturing, and commercialization under one integrated platform.
- Its portfolio spans oncology, cardiovascular, inflammation, bone health, and rare disease.
- Human genetics and biology guide its drug discovery strategy.
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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.