Regeneron
Regeneron
Regeneron este o companie de biotehnologie care descoperă, dezvoltă și comercializează medicamente pentru afecțiuni grave și insuficient deservite. Cercetările sale acoperă alergiile, bolile cardiovasculare și metabolice, neuroștiința, oncologia, hematologia, oftalmologia și bolile rare. Prin combinarea cercetării biologice cu tehnologia avansată, Regeneron dezvoltă medicamente biologice și genetice concepute pentru a răspunde unor nevoi complexe de sănătate. Compania pune, de asemenea, accent pe echitatea în sănătate, responsabilitatea față de mediu, educația științifică și practicile corporative etice, ca parte a misiunii sale mai ample de a îmbunătăți îngrijirea pacienților.

Associate Director, Data Validation Strategy — Regeneron Hybrid

Lead Regeneron’s clinical data validation and integrated data review strategy in a hybrid Associate Director role. Drive inspection-ready quality, risk-based review, analytics, and team development.

Descriere

  • Own the implementation and delivery of the Integrated Data Review strategy, operating model, standards, and governance.
  • Oversee Data Review Plan development, execution, quality, issue tracking, escalation, and resolution.
  • Partner with Biostatistics, QISS, Clinical Data Reporting, and study teams on risk-based reviews aligned with critical-to-quality factors.
  • Use KPIs and quality metrics to monitor performance, identify trends, and advance continuous improvement.
  • Help create SOPs, work instructions, templates, and training resources for Integrated Data Review activities.
  • Lead training, coaching, and change management to increase adoption across clinical and external data domains.
  • Advance innovation, automation, and AI-enabled analytics initiatives.
  • Manage, mentor, and develop the Integrated Data Review and Quality team.
  • Work cross-functionally with Clinical Data Management, Biostatistics, Clinical Data Reporting, QISS, and study teams.

Cerințe

  • Bachelor’s degree in life sciences, statistics, computer science, or a related discipline.
  • At least 10 years of Clinical Data Management experience in biotechnology, pharmaceuticals, or healthcare.
  • At least 5 years of experience leading people, teams, and projects.
  • Experience implementing integrated data review, quality management, risk-based data management, or centralized review processes.
  • Strong knowledge of ICH E6 (R3), ICH E8 (R1), GxP, 21 CFR Part 11, and RBDM/RBQM principles.
  • Experience supporting inspection-readiness activities.
  • Experience using data review, visualization, and analytics tools to identify issues proactively.
  • Willingness to work primarily on site with hybrid flexibility.
  • Ability to travel up to 25%.

Beneficii

  • Hybrid work flexibility.
  • Annual bonuses or other incentive opportunities.
  • Equity awards.
  • Pension or retirement benefits.
  • 401(k) company matching.
  • Health and wellness programs.
  • On-site fitness centers.
  • Medical, dental, vision, life, and disability insurance.
  • Paid time off.
  • Family support benefits.
  • Reasonable recruitment-process accommodations where required.

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