Strategic CDM Program Lead – Associate Director

Regeneron Pharmaceuticals Inc.; Cambridge (MA); Híbrido; USD 157.000 - 257.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. is seeking an Associate Director, Clinical Data Management, Program Lead to steer strategic CDM activities across assigned clinical programs, ensuring quality, timelines and budgets while collaborating with senior leadership, study teams, CROs and partners.

You will lead deliverables, oversee timelines and resources, promote data standards, and support inspection readiness. The role offers mostly onsite work with hybrid flexibility and the chance to influence

Formación

• Bachelor's degree in Mathematics, Science, or a related field is required.
• 10+ years of clinical data management experience in biotech/pharma/health.
• 5+ years of people management experience in a matrix environment.
• Strong knowledge of 21 CFR Part 11, ICH-GCP, and CDISC standards.

Responsabilidades

• Lead the overall success of CDM deliverables across studies and programs.
• Communicate program status, risks, and issues to collaborators and develop mitigation strategies.
• Provide CDM expertise during protocol design, start-up, and conduct, promoting standards and best practices.
• Oversee program timelines, resources, budgets, and act as escalation point for issues.
• Track metrics and KPIs, and manage Quality Events, CAPAs, and deviations.
• Represent CDM in review committees, CRO governance, and meetings with collaborators.
• Drive inspection readiness and coordinate CDM during regulatory inspections.
• Mentor and coach team members and manage recruitment, development, and performance.

Conocimientos

CDM leadership

Cross-functional collaboration

Regulatory knowledge

Project management

Communication skills

Educación

Bachelor's degree in Mathematics/Science/related field

Herramientas

CDISC standards

Descripción del empleo

Regeneron Pharmaceuticals, Inc. is seeking an Associate Director, Clinical Data Management, Program Lead to steer strategic CDM activities across assigned clinical programs, ensuring quality, timelines and budgets while collaborating with senior leadership, study teams, CROs and partners.

You will lead deliverables, oversee timelines and resources, promote data standards, and support inspection readiness. The role offers mostly onsite work with hybrid flexibility and the chance to influence