Manager, Local Lab Delivery

Regeneron Pharmaceuticals; Hyderabad; Hybrid; INR 1,800,000 - 2,500,000; Full time

Job summary

Regeneron Pharmaceuticals in Hyderabad is seeking a Manager, Local Lab Delivery to lead end-to-end local laboratory data management for our clinical development portfolio. You will oversee reference ranges, units, conversion factors, and mappings in laboratory systems, while building and guiding a team of Local Lab Delivery Specialists.

The role requires strong leadership, 7+ years in clinical data management, 5+ years in local lab delivery, and deep knowledge of GxP, EDC, and metadata

Qualifications

• Bachelor’s degree in Science, Health, Data Management, Mathematics, Computing, or related field.
• 7+ years of Clinical Data Management experience in biotech, pharma, CRO, or healthcare.
• 5+ years of Local Laboratory Delivery experience and 2+ years of people management.
• Advanced knowledge of local lab reference range management, analyte interpretation, unit conversions, and metadata management.
• Strong knowledge of clinical trial processes, EDC systems, and lab administration systems.
• Experience solving complex lab data issues with root cause analysis and CAPA.
• Familiarity with GxP requirements and inspection readiness.

Responsibilities

• Lead the operational delivery of local laboratory data activities across clinical studies.
• Oversee intake, interpretation, QC, maintenance, and delivery of local lab reference ranges and metadata.
• Ensure accurate configuration and quality oversight of local lab information in the EDC Lab Administration system.
• Provide guidance on study-specific local lab setup requirements and metadata.
• Maintain harmonization of lab metadata assets and reference range information.
• Escalate complex issues, drive root-cause analysis, CAPA, and process remediation.
• Collaborate with Clinical Data Management, Clinical Operations, study teams, vendors, and partners.
• Establish turnaround times, targets, and quality metrics for startup, data management, and DB lock.
• Ensure compliance with SOPs, quality standards, GxP, and inspection readiness.
• Drive continuous improvement and automation, including AI-enabled solutions and metadata classification.

Skills

Leadership

People management

Data management

Analytical skills

Stakeholder management

Cross-functional collaboration

Education

Bachelor's degree in science/related

Tools

EDC systems

Laboratory databases

Job description

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 Manager, Local Lab Delivery to lead the operational delivery, oversight, and continuous improvement of local laboratory reference range data management supporting our clinical development portfolio. In this role, you will oversee the end-to-end local laboratory data process, ensuring reference ranges, units, conversion factors, analyse mappings, and associated metadata are accurately interpreted, quality controlled, maintained, and configured within laboratory management systems. You will also lead and develop a team of Local Lab Delivery Specialists and collaborate across Clinical Data Management, Clinical Operations, study teams, technology teams, and external partners.

When & where:

Hyderabad (hybrid)

Discover your role:

• Lead the operational delivery of local laboratory data activities across clinical studies, ensuring timely execution, quality oversight, issue resolution, and effective study support.
• Oversee the intake, interpretation, quality control, maintenance, and delivery of local laboratory reference ranges and metadata, including units, conversion factors, analyse mappings, and study-specific configurations.
• Ensure accurate and timely configuration, maintenance, and quality oversight of local laboratory information within the EDC Lab Administration system.
• Provide consultation and guidance on study-specific local laboratory setup requirements, metadata, and complex local laboratory data issues.
• Oversee the maintenance, harmonization, and reuse of local laboratory metadata assets, including analyte libraries, laboratory templates, analyte mappings, units of measure, and reference range information.
• Serve as the escalation point for complex local laboratory data issues and lead root cause analysis, CAPA development, issue resolution, and process remediation activities.
• Partner with Clinical Data Management, Clinical Operations, study teams, system owners, technology teams, laboratory vendors, and external partners to drive successful local laboratory delivery.
• Establish and monitor turnaround times, operational targets, and quality metrics supporting study startup, ongoing data management activities, and database lock achievements.
• Ensure local laboratory data processes, systems, and documentation comply with SOPs, work instructions, quality standards, GxP requirements, and inspection-readiness expectations.
• Drive continuous improvement and technology enablement, including opportunities involving automation, AI-enabled solutions, document extraction, unit harmonization, metadata classification, test synonym mapping, and quality review.
• Lead, coach, mentor, and develop a team of Local Lab Delivery Specialists while managing performance objectives, development plans, workload allocation, resource planning, and operational priorities.

This role requires:

• Bachelor’s degree in Science, Health, Data Management, Mathematics, Computing, or a related field.
• 7+ years of Clinical Data Management experience within biotechnology, pharmaceutical, CRO, or healthcare environments.
• 5+ years of direct Local Laboratory Delivery experience and 2+ years of people management experience.
• Advanced knowledge of local laboratory reference range management, including analyte interpretation, unit conversions, conversion algorithms, test synonym mapping, reference range evaluation, and metadata management.
• Strong understanding of local laboratory data collection, validation, maintenance, quality control, and delivery processes supporting Clinical Data Management.
• Strong knowledge of clinical trial processes, Clinical Data Management principles, EDC systems, laboratory administration systems, and related clinical data technologies.
• Experience managing complex laboratory data issues through root cause analysis, CAPA development, issue resolution, and process remediation.
• Knowledge of applicable regulations, GxP requirements, clinical data quality principles, SOPs, and inspection-readiness expectations.
• Demonstrated experience with operational metrics, targets, turnaround times, quality indicators, process improvement, and operational excellence.
• Strong leadership and people-management capabilities, including coaching, mentoring, performance management, resource planning, and staff development.
• Strong analytical, problem-solving, decision-making, stakeholder management, and cross-functional collaboration skills.
• Exposure to automation, AI-enabled solutions, workflow optimization, metadata management, or digital transformation within laboratory data management is preferred.
• Excellent verbal, written, and interpersonal communication skills, with the ability to manage multiple priorities in a fast-paced environment.
• May require up to 25% travel

Does this sound like you? 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.

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 on‑site.

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.