At a Glance
- Tasks: Lead external data acquisition and delivery for groundbreaking clinical trials.
- Company: Join Regeneron, a leader in innovative pharmaceuticals making a real difference.
- Benefits: Competitive salary, bonuses, health benefits, and generous paid time off.
- Other info: Dynamic work environment with opportunities for growth and development.
- Why this job: Be part of a science-driven team transforming patient care with cutting-edge data solutions.
- Qualifications: 10+ years in clinical data management and strong leadership skills required.
The predicted salary is between 72000 - 88000 £ per year.
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Director to join our Clinical Data Management team. As an Associate Director, External Data Acquisition and Delivery (EDAD), you will provide strategic oversight and operational leadership for External Data Acquisition and Delivery activities across Regeneron’s clinical trial portfolio and initiatives. You will ensure readiness of external data collection platforms, data conformance tools, reconciliation processes, and the delivery of high-quality, compliant external data from third-party vendors including laboratory, biomarker, Digital Health Technologies, imaging, ECG, PK, genomics, and specialty data. You will partner closely with Clinical Data Management, CROs, external vendors, and cross-functional partners to drive external data strategy, operational excellence, vendor oversight, digital transformation initiatives, and process improvements. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
Discover your role:
- Leading External Data Acquisition, integration, quality oversight, and delivery strategy across the clinical trial portfolio
- Serving as a portfolio-level lead for external data quality and clinical-data operational strategy
- Reviewing protocol requirements, vendor specifications, and operational data flows
- Leading all aspects of development and maintenance of Data Transfer Specification (DTS) documents to ensure compliance with Regeneron standards and timelines
- Providing expert mentorship on external data services including biomarker, eSource, eCOA, imaging, ECG, PK, genomics, and laboratory data
- Driving external vendor oversight, onboarding, qualification, governance, and ongoing performance monitoring
- Establishing and handling vendor KPIs, SLAs, and quality metrics
- Governing reconciliation activities between EDC systems and vendor data platforms to ensure data integrity and consistency
- Monitoring reconciliation metrics, discrepancy trends, and resolution timelines across studies
- Collaborating with Database Development, Biostatistics, Study Data Managers, and external vendors to resolve complex data discrepancies
- Leading process improvement initiatives, automation opportunities, and implementation of innovative external data solutions
- Managing and developing a team of EDAD Managers, Specialists, and associates through coaching, mentoring, and performance management
- Supporting SOP development, inspection readiness, audit activities, and regulatory compliance
- Representing EDAD in leadership forums, governance committees, and technology discussions
This role requires:
- Minimum 10+ years of experience in Clinical Data Acquisition/Management within biotechnology, pharmaceutical, or healthcare industries
- Minimum 4+ years of people management experience
- Demonstrated experience overseeing external data reconciliation activities between EDC systems and vendor platforms
- Experience driving process improvements and vendor oversight in supervised environments
- Bachelor’s degree in Science, Health, Mathematics, Computing, Information Systems, or a related field
- Advanced degree preferred
- Strong expertise managing multiple clinical external data types including biomarker, imaging, eCOA, ECG, PK, genomics, laboratory, and Digital Health Technology data
- Advanced knowledge of external data reconciliation processes and EDC platforms such as Medidata Rave, Veeva, or Oracle Inform
- Experience working with SAS, CSV, and XML data formats
- Strong understanding of industry regulations including 21 CFR Part 11, ICH-GCP, and CDISC standards
- Proven experience handling external vendor relationships and driving accountability for quality deliverables
- Strong leadership, people management, coaching, and mentoring capabilities
- Strategic thinking, creativity, problem-solving, and analytical skills
- Strong project management and stakeholder management capabilities
- Excellent verbal and written communication skills
- Ability to work effectively in a fast-paced, matrixed, and global environment
We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
Associate Director, External Data Acquisition and Delivery employer: Regeneron Pharmaceuticals
Regeneron is an exceptional employer, offering a dynamic work environment where innovation and collaboration thrive. As a Sales Specialist in Oncology, you will have the opportunity to engage with healthcare professionals and contribute to a growing oncology portfolio while benefiting from a comprehensive rewards package, including competitive bonuses and health programs. With a strong commitment to inclusivity and employee development, Regeneron fosters a culture that empowers you to excel in your career while making a meaningful impact in the healthcare sector.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director, External Data Acquisition and Delivery
✨Get Involved in Local Research Communities
Tap into local biotechnology meetups and research forums. These are great places to mingle with industry professionals, share your passion, and even discover unadvertised job openings. It's all about getting your face known in the field!
✨Leverage University Alumni Networks
If you're a recent grad, don’t underestimate the power of your university’s alumni network! Reach out to alumni working in biotechnology to gather tips about job openings at companies like Regeneron Pharmaceuticals. You'd be surprised how willing people are to help out a fellow grad!
✨Show Off Your Projects
Curate a portfolio showcasing any research projects or internships you've completed in biotechnology. This tangible evidence of your skills can really impress employers when you chat with them at networking events or interviews. It's about making that killer first impression!
✨Stay Up-to-Date with Industry Trends
Biotech is a fast-paced field, so keeping yourself updated with the latest advancements is crucial. Attend industry conferences, webinars, or workshops to broaden your knowledge and meet potential employers. Plus, it’ll give you fantastic talking points for your interviews at places like Regeneron Pharmaceuticals!
We think you need these skills to ace Associate Director, External Data Acquisition and Delivery
Some tips for your application 🫡
Show Off Your Lab Skills:In the biotechnology field, it's super important to highlight your lab experience in your CV. Be sure to mention specific techniques or instruments you've mastered (think PCR, gel electrophoresis, etc.) and any relevant projects you've worked on. This will show Regeneron Pharmaceuticals that you have the hands-on skills they need.
Tailor Your Technical Skills:Make sure to emphasise your technical skills, especially those relevant to the biotechnology sector. Include any software tools or programming languages you've used, like R or Python for data analysis, which could be key for this role at Regeneron Pharmaceuticals.
Craft a Compelling Cover Letter:Since this is a full-time role, your cover letter should reflect not only your passion for biotechnology but also your long-term career ambitions. Share why you're excited about the work that Regeneron Pharmaceuticals does and how you envision contributing to their goals. This shows that you’re not just looking for any job, but you're genuinely invested in this opportunity.
Include Your Papers and Projects:If you've published any papers or contributed to significant projects, mention them! These documents can boost your application and provide tangible evidence of your expertise in the biotechnology field. Don’t forget to link to any relevant publications or project summaries—this can set you apart from other candidates.
How to prepare for a job interview at Regeneron Pharmaceuticals
✨Brush Up on Lab Techniques
Since you're eyeing a full-time gig in biotechnology, make sure you're well-versed in the lab techniques relevant to the role. Be ready to talk about PCR, CRISPR, or any specific methods mentioned in the job description at Regeneron Pharmaceuticals. You might even be asked to demonstrate your understanding of these processes.
✨Know Your Bioinformatics Tools
Get comfortable with bioinformatics tools that are commonly used in the industry, like BLAST or Bioconductor. These are key in biotechnology, and having hands-on experience or at least familiarity can set you apart. Prepare to discuss any relevant projects you've worked on, especially if they involved data analysis or genomic research.
✨Show Your Teamwork Skills
Biotech often involves collaboration across multiple disciplines. Be ready to share stories that highlight your teamwork and communication skills, especially in research projects. Think about working with different teams at university or any internships – this is where you can show how well you fit into Regeneron Pharmaceuticals's culture.
✨Research Recent Biotech Innovations
Stay updated on the latest trends and breakthroughs in biotechnology. Knowing what's happening in the field can help you engage in more meaningful discussions during your interview. Bring up recent articles or advancements that excite you, especially those related to the work being done at Regeneron Pharmaceuticals. This shows your passion for the industry!
