Full-Time
Associate Director, Database Design
Clinical Development, Data Management
Updated on 8/23/2026
Amgen
10,001+ employees
Biotech company creating biologic medicines
No salary listed
Hyderabad, Telangana, India
In Person
Bachelor's, Master's, PhD
 Biology & Biotech (1) |
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- A doctorate degree and 10 years of relevant experience, or a master's degree and 13 years of relevant experience, or a bachelor's degree and 15 years of relevant experience.
- At least 5 years of people management experience, including managing managers, leading global teams, portfolios, organizational strategy, or enterprise resource planning activities within clinical development organizations.
- Leadership experience with Vault CDMS, Medidata Rave, and enterprise clinical data ecosystems.
- Expertise in metadata-driven design and analytics-ready data solutions.
- Experience defining operating models, governance frameworks, and enterprise database delivery strategies.
- Experience building and leading high-performing global organizations and leadership teams.
- Portfolio leadership experience across complex global therapeutic area programs.
- Strong understanding of CDISC, SDTM, RBQM, inspection readiness, and regulatory compliance frameworks.
- Experience influencing executive stakeholders and enterprise-level strategic decisions.
- Expertise in automation, metadata-driven design, interoperability, AI-enabled validation, and scalable clinical data ecosystems.
- Ability to lead organizational transformation and enterprise modernization initiatives.
- Ability to influence enterprise decisions across highly matrixed global organizations.
- Strong risk management, inspection readiness, and compliance leadership capabilities.
- Demonstrated ability to build scalable, high-performing global organizations and delivery models.
- Own and drive enterprise database design strategy across therapeutic area portfolios.
- Lead adoption and evolution of governance frameworks, reusable libraries, and validation methodologies.
- Lead workforce planning, talent development, and succession planning activities.
- Drive enterprise standardization and scalability of database design practices.
- Lead modernization initiatives including artificial-intelligence-enabled validation and automation.
- Partner with Digital and Technology organizations and cross-functional stakeholders.
- Provide strategic oversight of portfolio-level delivery, quality, compliance, and inspection readiness.
- Develop Senior Managers and functional leaders.
- Drive organizational design and capability development strategies.
- Lead continuous improvement and operational excellence initiatives.
- Lead leaders and Senior Managers across therapeutic areas to ensure alignment with enterprise objectives.
- Drive organizational design strategies and workforce evolution plans to support future-state database design capabilities.
- Influence enterprise clinical data strategy, operating models, and future-state clinical data capabilities.
- Lead governance forums and resolve complex database design, integration, and compliance issues across programs and portfolios.
- Mentor and develop Senior Managers and functional leaders while driving workforce planning and succession planning initiatives.
- Own enterprise database design operating model evolution for strategy, governance, modernization, and operational excellence across global portfolios.
- Ensure delivery of scalable, compliant, inspection-ready, and analytics-enabled database solutions across studies and programs.
- Lead and develop Senior Managers and functional leadership teams while driving standardization, automation, innovation, and organizational capability development.
- Influence enterprise database operating models, governance frameworks, digital transformation, and future-state clinical data capabilities.
- Drive portfolio-level operational performance, scalability, modernization, and continuous improvement initiatives aligned with enterprise objectives.
- Establish enterprise and therapeutic area database design strategy and governance frameworks.
- Approve portfolio-wide metadata standards, reusable libraries, validation methodologies, and modernization initiatives.
- Influence enterprise clinical technology roadmaps and automation strategies related to database design.
- Allocate leadership resources and prioritize portfolio-level database delivery activities.
- Escalate and resolve enterprise-level operational, compliance, and database design risks.
- Define organizational priorities, leadership expectations, and capability development strategies.
- At least 15 years of clinical research, clinical data management, or database design experience.
- Proven experience leading enterprise-scale transformation initiatives.
- Demonstrated success leading organizational change and digital transformation initiatives.
- Strategic thinking combined with strong operational execution orientation.
- Strong executive communication, stakeholder management, and organizational influence skills.
- Strong leadership development, mentoring, succession planning, and talent management capabilities.
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 $10.1 billion, up 10%, and guidance rose to $39.4 billion.
- Repatha, Evenity, and Uplizna surged 37%, 38%, and 90% in Q2 2026.
- Amgen presented Repatha VESALIUS-CV data for ESC August 2026, expanding cardiovascular adoption.
What critics are saying
- FDA proposed withdrawing Tavneos on April 27, 2026; EMA echoed revocation on June 26.
- Prolia sales fell 32% in Q2 2026 as biosimilars attack Amgen’s legacy franchise.
- Harbour BioMed won a June 2026 willful patent verdict; MariTide failure would crush growth.
What makes Amgen unique
- Amgen’s portfolio spans cardiovascular, bone, immunology, oncology, and biosimilars.
- MariTide targets monthly or less frequent obesity dosing, unlike weekly GLP-1 rivals.
- Amgen runs seven research labs plus Hyderabad’s 2027 science and innovation center.
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Company News
Amgen shares jumped 3.5% to $440.08 on Wednesday as healthcare stocks reached record highs. The biotech company reported second-quarter revenue of $10.1 billion, up 10%, whilst GAAP earnings surged 65% to $4.37 per share. Twenty-two of Amgen's medicines posted double-digit sales growth, with seventeen products generating over $1 billion in annualised sales. Six key growth products climbed 26% and now account for nearly 70% of product revenue. The rally came as investors rotated into healthcare following excitement around Merck and Moderna's melanoma breakthrough. However, Amgen now trades at a 19% premium to its fair value estimate of $365.04, putting pressure on execution as some products like Prolia face headwinds.
Amgen and Regeneron could benefit from surging demand for GLP-1 drugs, which traditionally treated diabetes but now address obesity and obstructive sleep apnea. Amgen's stock is up 27% this year, with second-quarter revenue rising 10% year-over-year to $10.1 billion. The company is testing MariTide, an investigational GLP-1 medicine, in phase 3 studies for weight management and diabetes. MariTide could be administered monthly or less frequently, offering a convenience advantage over current daily or weekly treatments. Regeneron is also positioned to capitalise on the GLP-1 market expansion. Both companies present alternatives to current market leaders Eli Lilly and Novo Nordisk for investors seeking exposure to the growing GLP-1 drug category.
Amgen announced plans to open a new Science and Innovation Center in Genome Valley, Hyderabad, expected to be operational in 2027. The facility will join Amgen's global Research and Development network of seven research laboratories, expanding the company's scientific capabilities. The center will bring together scientists and technologists across discovery chemistry, drug metabolism and pharmacokinetics, and precision medicine. It will integrate experimental science with data and digital innovation to accelerate the discovery and development of medicines. "The new center in Genome Valley expands the way we integrate experimental science with data and technology across our global research capabilities," said Jay Bradner, executive vice president of Research and Development, Artificial Intelligence and Data at Amgen. The facility will complement Amgen's existing technology and innovation site in Hyderabad.
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.