Senior Manager Clinical Sciences

By Admin ยท Clinical Research & Clinical Operations

HYDERABAD (IN)HYBRIDPOSTED: 8/27/2026
PHARMAFull-time
HIRING ORGANIZATIONREGENERONBiopharmaceuticals
Regeneron

ROLE DEFINITION & RESPONSIBILITIES

Role Summary

Lead and manage a centralized pool of Clinical Data Reviewers (CDRs) and Medical Narrative Reviewers (MNRs) within Regeneron's Global Capability Center in Hyderabad.
Provide high-quality clinical review support across the development portfolio while managing onboarding, training, performance, resource allocation, capacity planning, and operational excellence.
Partner with Clinical Scientists, Medical Directors, Clinical Program Leads, and other cross-functional stakeholders.

Clinical Operations & Review Responsibilities

Lead day-to-day functional management of centralized CDR and MNR resources and act as the primary point of contact for resource coordination across studies and programs.
Translate portfolio-level study assignments into resource-prioritization plans and monitor delivery against achievements and operational objectives.
Personally perform clinical data review, query management, and medical narrative review when needed for coverage gaps, onboarding, workload surges, or quality-remediation activities.
Ensure continuity of clinical-review operations during team transitions, turnover, protocol changes, and study closeouts.

Quality, Governance & Performance

Establish, monitor, and report key performance indicators (KPIs).
Ensure compliance with SOPs, Restricted Data Handling requirements, and quality standards.
Drive operational excellence and maintain consistent reviewer practices across the clinical development portfolio.
Support knowledge management, institutional learning, and quality/process-improvement initiatives.

People Leadership & Workforce Planning

Lead onboarding and training, including SOP assignment, systems-access support, and reviewer-readiness assessments.
Partner with Clinical Scientists and Study Medical Directors to ensure reviewers are appropriately trained and ready for study activities.
Drive capacity forecasting and workforce planning with Clinical Scientist Leads and Clinical Program Leads to align resources with study timelines and business needs.
Manage, coach, and develop clinical and medical professionals in a matrixed and cross-functional environment.
Influence and lead distributed teams while maintaining strong communication, collaboration, and stakeholder relationships.

Scientific & Technical Requirements

Advanced degree in a scientific or medical field required; MD, PhD, PharmD, or equivalent strongly preferred.
Minimum 7 years of experience in clinical research, drug development, pharmaceutical operations, or related healthcare environments.
Hands-on experience in 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.
Strong scientific and medical competence to understand, evaluate, and communicate complex clinical-development concepts.
Strong analytical, critical-thinking, problem-solving, operational-leadership, quality-governance, and stakeholder-management capabilities.
High integrity, professionalism, and discretion when handling sensitive information.

Work Environment

Hyderabad-based hybrid position within Regeneron's Global Capability Center.
Role contributes to Regeneron's global medicine-development portfolio and science-driven patient-focused mission.

REQUIRED VERIFIED SKILLS

Advanced Degree in Scientific or Medical Field
MD/PhD/PharmD or equivalent
7+ years clinical research experience
Drug Development
Pharmaceutical Operations
Clinical Data Review
Medical Narrative Review
EDC Systems
Clinical Data Review Tools
Query Management
SOP Compliance
Restricted Data Handling
Quality Standards
KPI Management
Capacity Planning
Workforce Planning
Clinical Development

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting

ORGANIZATION CONTEXT & CULTURE

Regeneron is actively hiring for this position.

INDUSTRY: Biopharmaceuticals

READY TO SUBMIT?

Verify your capability profile and matching credentials before submitting direct applications.