BioSpace
Website:
biospace.com
Job details:
Build Our Future Together
Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. In doing so, we are pioneering innovative approaches to science, manufacturing, and commercialization, as well as redefining our understanding of health.
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Director, Global Development Solutions to join our Global Development Digital & Technology organization. In this leadership role, you will be responsible for building and scaling Global Development technology capabilities within our Global Capability Center while serving as a strategic partner to business and technology leaders worldwide. You will lead the delivery of innovative technology, data, AI, and digital solutions that support Clinical Operations, Biostatistics & Data Management, Regulatory Affairs, Quality, Medical Affairs, and Drug Safety. This role offers a unique opportunity to shape the future of digital transformation in drug development by combining deep industry expertise, technology leadership, compliance excellence, and organizational growth within a highly collaborative global environment.
When & Where
Hyderabad, India (Hybrid)
Discover Your Role
- Lead and scale the Global Development Digital & Technology organization within the India Global Capability Center, fostering a high-performance, inclusive, and innovation-driven culture.
- Build and expand Global Development technology capabilities through strategic hiring, onboarding, talent development, and organizational design.
- Partner with Global Development and Technology leadership teams to define and implement business-aligned digital strategies that accelerate drug development objectives.
- Lead end-to-end technology, architecture, data, and AI solution delivery across Agile and traditional delivery models.
- Drive operational excellence through delivery governance, performance metrics, delivery predictability, and continuous process improvement.
- Establish and maintain inspection-ready validation programs aligned with GxP requirements, Computer System Validation standards, and data integrity principles.
- Ensure compliance with applicable regulatory requirements, including 21 CFR Part 11, EU Annex 11, ICH guidelines, and evolving global regulatory expectations.
- Drive adoption of AI and Generative AI capabilities by identifying and implementing compliant, value-generating solutions across the drug development lifecycle.
- Act as a strategic advisor to senior collaborators by translating complex scientific and business challenges into scalable technology solutions.
- Communicate effectively with executive leadership and cross-functional teams across global regions, driving alignment and informed decision-making.
This Role Requires
- Bachelor's degree in Computer Science, Information Technology, Engineering, Life Sciences, Business, or a related field; advanced degree preferred.
- Significant leadership experience within pharmaceutical, biotechnology, healthcare, or other highly regulated industries.
- Deep knowledge of pharmaceutical and biotechnology drug development functions, including Clinical Operations, Biostatistics & Data Management, Regulatory Affairs, Quality, Medical Affairs, and Drug Safety/Pharmacovigilance.
- Experience leading large-scale technology organizations and global delivery teams across architecture, engineering, data, and AI rigors.
- Strong understanding of technology platforms supporting Global Development, including CTMS, EDC, Regulatory Information Management systems, Safety systems, Statistical Computing environments, and Clinical Data Repositories.
- Strong knowledge of GxP compliance, Computer System Validation (CSV/CSVa), ALCOA+ data integrity principles, and global regulatory requirements.
- Experience establishing and expanding Global Capability Center (GCC) organizations or similar global operating models.
- Demonstrated experience evaluating, implementing, and governing AI and Generative AI solutions within regulated environments.
- Proven ability to influence senior stakeholders and operate effectively within complex global matrix organizations.
- Strong critical thinking, organizational leadership, problem-solving, change management, and executive communication skills.
- Advanced degree or equivalent experience such as MS, MBA, PharmD, or equivalent.
- Experience leading global digital transformation initiatives within Clinical Development or Research organizations.
- Experience working within highly matrixed global organizations across multiple geographies.
- Strong understanding of emerging technologies, cloud platforms, advanced analytics, and AI-enabled solutions supporting Drug Development functions.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
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