Senior Director managing Brookings plant operations for medical products at Solventum. Driving operational excellence and fostering a supportive culture for over 1200 employees.
About the role
- Associate Director overseeing External Data Management at Regeneron. Leading teams and ensuring compliance with industry best practices and standards.
Responsibilities
- Oversee team members to ensure all activities align with Regeneron’s procedures and industry best practices.
- Collaborate closely with Clinical Data Management teams and External Data Vendors to deliver structured external data in compliance with Regeneron SOPs.
- Shape and implement the strategy for External Data Services.
- Lead and manage a team of External Data Services Managers and Specialists.
- Oversee the development and maintenance of all DTS documents, ensuring alignment with Regeneron standards, processes, and timelines.
- Drive the External Data Vendor Oversight model, establishing effective communication, partnership-level processes, and portfolio-level transparency on DTS status and escalations.
- Represent External Data Services in leadership forums and technology discussions.
- Provide expert-level guidance to CROs, stakeholders, and external vendors on External Data Services.
- Identify process gaps and lead initiatives to improve processes.
- Track milestones and deliverables, escalate issues, and communicate portfolio-level updates to stakeholders.
- Lead or contribute to special projects requiring strategic input and expertise in External Data.
- Develop SOPs, Work Instructions, Guidance Manuals, and other DTS development tools.
- Provide coaching, mentoring, and performance management for direct reports.
- Manage resource allocation and planning for External Data Services.
Requirements
- A minimum of 10+ years of experience in External Clinical Data Management, with expert knowledge of database structures in biotechnology, pharmaceutical, or health-related industries.
- At least 4 years of people management experience.
- A Bachelor’s degree in Science, Health, Computing, or a related field.
- Hands-on experience with Imaging Data is required.
- Advanced knowledge of Biomarker data types and/or Imaging Data for oncology and non-oncology studies is a plus.
- Expert knowledge of database structures is preferred.
Benefits
- Health and wellness programs (including medical, dental, vision, life, and disability insurance)
- Fitness centers
- 401(k) company match
- Family support benefits
- Equity awards
- Annual bonuses
- Paid time off
- Paid leaves (e.g., military and parental leave) for eligible employees at all levels
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