Senior Manager Clinical Sciences

Lead and manage a centralized pool of Clinical Data Reviewers (CDRs) and Medical Narrative Reviewers (MNRs) within Regeneron's Global Capability Center (GCC) in Hyderabad.

Provide high-quality clinical review support across the development portfolio while partnering with Clinical Scientists, Medical Directors, and other cross-functional stakeholders.

Own functional management, onboarding, training, performance management, resource allocation, capacity planning, quality governance, and operational excellence.

Lead day-to-day functional management of Clinical Data Reviewers and Medical Narrative Reviewers.

Serve as the primary point of contact for resource coordination across studies and clinical programs.

Translate portfolio-level study assignments into resource-prioritization plans.

Monitor delivery against achievements, operational objectives, study requirements, and timelines.

Personally perform clinical data review, query management, and medical narrative review when necessary to address coverage gaps, onboarding periods, workload surges, or quality-remediation activities.

Establish, monitor, and report key performance indicators (KPIs).

Ensure adherence to SOPs, Restricted Data Handling requirements, and applicable quality standards.

Maintain quality governance and operational continuity during team transitions, employee turnover, protocol changes, and study closeouts.

Promote consistent reviewer practices and high-quality clinical review execution across the portfolio.

Handle sensitive information with a high level of integrity, professionalism, confidentiality, and discretion.

Lead onboarding and training programs for reviewers.

Coordinate SOP assignments and systems-access support.

Conduct or support reviewer-readiness assessments in partnership with Clinical Scientists and Study Medical Directors.

Support development of reviewer capabilities and consistent application of clinical review processes.

Drive capacity forecasting and workforce-planning activities.

Collaborate with Clinical Scientist Leads and Clinical Program Leads to align resources with study timelines and business requirements.

Prioritize resources across studies and programs based on portfolio needs.

Ensure appropriate resource continuity throughout changing study demands.

Support knowledge management and institutional learning across the Clinical Sciences organization.

Promote consistency of reviewer practices across the clinical-development portfolio.

Represent the Clinical Sciences function within the GCC.

Contribute to strategic initiatives focused on quality, operational efficiency, and process improvement.

Manage, coach, and develop clinical and medical professionals in a matrixed and cross-functional environment.

Influence and lead distributed teams through strong communication and collaboration.

Partner closely with Clinical Scientists, Medical Directors, Study Medical Directors, Clinical Scientist Leads, Clinical Program Leads, and other stakeholders.

Balance functional leadership responsibilities with hands-on clinical review activities when required.

Advanced degree in a scientific or medical field required; MD, PhD, PharmD, or equivalent is strongly preferred.

Minimum 7 years of experience in clinical research, drug development, pharmaceutical operations, or related healthcare-industry environments.

Hands-on experience performing clinical data review and/or medical review of patient narratives.

Practitioner-level knowledge of EDC systems, clinical data review tools, query-management processes, and medical narrative review activities.

Demonstrated experience managing, coaching, and developing clinical or medical professionals.

Strong operational leadership, quality governance, and stakeholder-management capabilities.

Strong analytical, critical-thinking, problem-solving, communication, collaboration, and interpersonal skills.

Scientific and medical competence to understand, evaluate, and communicate complex clinical-development concepts.

Willingness to perform hands-on review activities when required for quality, continuity, and timely delivery.

Location: Hyderabad, Telangana, India.

Hybrid work arrangement.

The role is part of Regeneron's Global Capability Center and Global Development organization.

Regeneron states that compensation is determined within the applicable country and role range based on role level, skills, and experience.

Depending on country and role, total rewards may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, health and wellness programs, insurance benefits, paid time off, and family-support benefits.

Specific India compensation and benefits details are to be provided during the recruitment process.