Full-Time
Design & Innovation Director
Updated on 9/12/2026
Amgen
10,001+ employees
Biotech company creating biologic medicines
No salary listed
Hyderabad, Telangana, India
In Person
Master's, PhD
 Biology & Biotech (1) |
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- A Master's degree or higher in Statistics, Biostatistics, Computer Science, Mathematics, Life Sciences, or a related scientific discipline.
- At least 8 years of experience in the pharmaceutical, biotechnology, or medical research industry.
- Demonstrated experience in people management, including direct reports.
- Strong written and verbal English communication skills.
- Experience working effectively in a globally distributed, cross-cultural environment.
- Strong foundational understanding of clinical statistical principles and/or clinical data standards.
- Ability to guide and challenge teams on fit-for-purpose approaches without needing to be the deepest technical expert in every area.
- Ability to communicate complex topics clearly and credibly to varied audiences.
- Ability to build trust and effective partnerships across functions and geographies.
- Ability to influence without formal authority.
- Provide leadership for Design & Innovation functions based in India, ensuring delivery of high-quality, compliant, and value-added outputs aligned with global standards and strategy.
- Serve as the primary people leader and managerial owner for India-based staff across Biomedical Data Stewardship, Centralized Statistical Monitoring, Safety Statistics, and Global Randomization and Blinding.
- Act as a strategic partner to global Design & Innovation leaders, supporting execution of the global vision while representing India capabilities, capacity, and growth opportunities.
- Drive adoption of innovative design, statistical, data stewardship, centralized statistical monitoring, safety monitoring, and randomization and blinding approaches in collaboration with global function heads.
- Ensure consistent application of company policies, standard operating procedures, and controlled documents across India-based Design & Innovation activities.
- Support capability development, talent pipeline growth, and succession planning for Design & Innovation functions in India.
- Provide oversight of resourcing, prioritization, and workload balancing across India-based teams.
- Translate global Design & Innovation strategy into executable plans for India-based teams.
- Support delivery of innovative statistical methodologies, data standards, centralized statistical monitoring, safety monitoring, and randomization and blinding services.
- Partner with global leaders to identify opportunities for expanding Design & Innovation capabilities and scope in India.
- Ensure operational excellence, quality, and regulatory compliance across supported functions.
- Recruit, develop, coach, and retain Design & Innovation staff in India.
- Build a leadership bench across Biomedical Data Stewardship, Centralized Statistical Monitoring, Safety Statistics, and Global Randomization and Blinding in alignment with future-state organizational needs.
- Oversee performance management, development planning, and career progression for direct reports.
- Act as the primary liaison between India-based Design & Innovation, CfDA teams, and global counterparts.
- Collaborate with Development Therapeutic Areas, Global Biostatistics, Global Patient Safety, Dev IS, CfOR, PMED, and other partners as needed.
- Support global and local initiatives related to innovation, process improvement, technology adoption, and standards implementation.
- Ensure adherence to regulatory expectations, internal controls, and quality standards.
- Support development, review, and implementation of policies, standard operating procedures, and standards relevant to Design & Innovation activities.
- Participate in audits, inspections, and quality reviews as required.
- A doctorate degree in Statistics, Biostatistics, or a related field.
- Experience in statistical innovation, data stewardship, safety statistics, centralized statistical monitoring, or randomization and blinding.
- Working knowledge of drug development across multiple phases.
- Experience with regulatory submissions and interactions.
- Demonstrated success leading multidisciplinary teams in a matrixed organization.
- Experience driving innovation, process improvement, or capability build-out.
- Experience developing or implementing policies, standard operating procedures, and standards.
- Budget, resource planning, and vendor oversight experience.
- External visibility through industry groups, forums, or professional organizations.
- Appreciation for innovative methods and emerging industry trends.
- Proven ability to lead, develop, and motivate diverse teams.
- A strong coaching mindset with a track record of growing talent.
- Experience leading through influence in a matrixed, global environment.
- Understanding of how Design & Innovation capabilities support broader development and business objectives.
- Ability to balance innovation, quality, speed, and operational efficiency.
- Sound judgment in prioritization and resource allocation.
- Ability to influence without formal authority.
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 rose 10% to $10.1 billion, and guidance increased to $38.2 billion-$39.4 billion.
- Repatha sales jumped 37% to $953 million in Q2 2026, with U.S. prescriptions up 50%.
- MariTide advanced through multiple Phase 3 studies in 2026, supporting a 2027 obesity catalyst.
What critics are saying
- Prolia sales fell 32% in Q2 2026 as biosimilars attack Amgen’s legacy cash cow.
- FDA proposed withdrawing Tavneos in April 2026, signaling regulatory risk from integrity and efficacy issues.
- Olpasiran now faces Novartis pelacarsen failure scrutiny; a negative 2028 OCEAN(a) readout would crush Lp(a) upside.
What makes Amgen unique
- Repatha, Evenity, and Uplizna diversify Amgen beyond one blockbuster, per August 2026 sales.
- MariTide targets quarterly or eight-week dosing, unlike Lilly and Novo Nordisk weekly injections.
- Amgen’s 2027 Hyderabad Science and Innovation Center expands AI-enabled drug discovery globally.
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Company News
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.
Amgen faces heightened scrutiny for its experimental heart drug olpasiran after rival Novartis's pelacarsen failed to reduce major cardiovascular events in a Phase 3 trial, despite successfully lowering lipoprotein(a) levels. The setback demonstrates that improving laboratory biomarkers may not translate to better patient outcomes. Amgen's OCEAN(a) outcomes study has enrolled 7,297 participants and is tracking heart-related deaths and procedures over roughly five years. While olpasiran uses a different design and may target different patients, pelacarsen's failure removes assumptions about the commercial value of lowering Lp(a). Amgen's shares traded at $437.23, sitting 19.54% above its estimated fair value of $365.76. The company reported $10.1 billion in second-quarter revenue and $3.5 billion in free cash flow.
Jim Cramer highlighted Amgen's cholesterol drug Repatha as a key driver behind the company's 31% year-to-date rally, calling it an overlooked catalyst by Wall Street. The injectable treatment, administered every two weeks, reduces death risk by 20% in patients at high risk for heart attack or stroke. Repatha generated $953 million in second-quarter sales, up 37% year-over-year. US new prescriptions surged over 50%, split evenly between cardiologist use and primary-care adoption for high-risk patients. Cramer noted the drug works against diabetes and high cholesterol, though insurance reimbursement has posed challenges. Amgen trades at a forward PE of 19, compared to Eli Lilly's 32, whilst outperforming Lilly's 10% gain this year. Repatha is one of six growth drivers representing nearly 70% of Amgen's product sales. The company raised full-year revenue guidance to $38.2-$39.4 billion.
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.