At a Glance
- Tasks: Lead a team to manage external data services and ensure compliance with industry standards.
- Company: Join Regeneron, a leader in biotechnology with a commitment to innovation.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Opportunity to work on cutting-edge projects and collaborate with diverse teams.
- Why this job: Shape the future of data management in a dynamic and impactful environment.
- Qualifications: 10+ years in External Clinical Data Management and strong leadership skills required.
The predicted salary is between 70000 - 90000 € per year.
The Associate Director, External Data Services, plays a critical leadership role, overseeing team members to ensure all activities align with Regeneron’s procedures and industry best practices. This position collaborates closely with Clinical Data Management teams and External Data Vendors to deliver structured external data in compliance with Regeneron SOPs. The role also involves coaching, mentoring, and managing the performance of direct reports, while contributing to the department's strategic direction. Additionally, the AD works with senior leadership to define goals, staffing needs, and departmental structure.
A typical day in the life as an Associate Director, External Data Services includes:
- 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.
- Contribute to and execute the External Data Services technology strategy.
- 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, escape issues, and communicate portfolio-level updates to stakeholders.
- Lead or contribute to special projects requiring strategic input and expertise in External Data.
- Serve as a subject matter expert (SME) for complex topics requiring leadership-level commitment.
- 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.
This Role Might Be for You If You:
- Have expert knowledge of regulations like 21 CFR Part 11, ICH-GCP Guidelines, and CDISC standards for data collection.
- Possess deep expertise in Data Management, External Data processes, and industry best practices.
- Demonstrate advanced experience with extracting data in SAS, CSV, and XML formats.
- Can address complex External Data challenges and recommend actionable solutions.
- Have a proven ability to develop best practices and processes to achieve objectives.
- Exhibit strong problem-solving, analytical, and project management skills.
- Thrive in a matrix environment with virtual teams and can motivate others effectively.
- Possess an excellent understanding of cross-functional activities and their intersections with External Data.
- Manage multiple priorities with attention to detail and deliver results within tight timelines.
- Communicate effectively through strong interpersonal, oral, and written skills.
- Adapt quickly in a fast-paced, dynamic environment.
- Are open to travel up to 20%.
To be qualified for this role, you must meet the following 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.
Associate Director, External Data Management in Uxbridge employer: Regeneron
Regeneron is an exceptional employer that fosters a collaborative and innovative work culture, particularly for the Associate Director, External Data Management role. Employees benefit from comprehensive professional development opportunities, a commitment to diversity and inclusion, and the chance to lead impactful projects in a dynamic environment. With a focus on strategic growth and employee well-being, Regeneron provides a supportive atmosphere where your expertise can truly make a difference.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director, External Data Management in Uxbridge
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who work at Regeneron or similar companies. A friendly chat can open doors and give you insider info that could help you stand out.
✨Tip Number 2
Prepare for interviews by practising common questions related to External Data Management. Think about how your experience aligns with Regeneron's needs and be ready to share specific examples of your past successes.
✨Tip Number 3
Showcase your leadership skills! Be ready to discuss how you've coached and mentored teams in the past. Highlighting your ability to manage performance and drive results will resonate well with hiring managers.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you're genuinely interested in joining the team at Regeneron.
We think you need these skills to ace Associate Director, External Data Management in Uxbridge
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter to highlight your experience in External Data Management. We want to see how your skills align with the role, so don’t hold back on showcasing your expertise in regulations and data processes!
Showcase Leadership Skills:Since this role involves managing a team, it’s crucial to demonstrate your leadership experience. Share examples of how you’ve coached or mentored others, and how you’ve contributed to strategic goals in your previous roles.
Be Clear and Concise:When writing your application, clarity is key! Use straightforward language and structure your thoughts logically. We appreciate well-organised applications that make it easy for us to see your qualifications at a glance.
Apply Through Our Website:We encourage you to submit your application through our website. It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it’s super easy to do!
How to prepare for a job interview at Regeneron
✨Know Your Regulations
Make sure you brush up on key regulations like 21 CFR Part 11 and ICH-GCP Guidelines. Being able to discuss these confidently will show that you’re not just familiar with the rules, but that you can apply them in real-world scenarios.
✨Showcase Your Leadership Skills
Since this role involves managing a team, be prepared to share examples of how you've successfully led teams in the past. Highlight your coaching and mentoring experiences, and how you’ve contributed to strategic direction in previous roles.
✨Demonstrate Problem-Solving Abilities
Think of specific challenges you've faced in External Data Management and how you overcame them. This will help illustrate your analytical skills and ability to recommend actionable solutions, which is crucial for this position.
✨Communicate Effectively
Practice articulating your thoughts clearly and concisely. Strong interpersonal and written communication skills are essential, so consider preparing a few key points about your experience that you can convey smoothly during the interview.
