At a Glance
- Tasks: Lead complex clinical programs and ensure successful delivery of clinical trials.
- Company: Join a leading pharmaceutical company focused on innovation in healthcare.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Dynamic role with potential for travel and collaboration with top industry professionals.
- Why this job: Make a real impact in clinical research and drive operational excellence.
- Qualifications: Bachelor's degree with extensive experience in clinical operations.
The predicted salary is between 80000 - 100000 € per year.
Location: Uxbridge
Work Mode: Hybrid (3 days on-site, 2 days from home)
Employment Type: Full time
The Program Operations Leader (POL) is responsible for leadership of and setting and implementation of the operational strategy for delivery of one or more complex programs in Clinical Trial Management (CTM). This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s).
The POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. The POL is responsible for line management of clinical trial management staff (including AD POL), and has responsibility for staff recruitment, development, coaching, mentoring and performance management. Plays a key role in driving the functional strategy of Clinical Trial Management in partnership with Functional leadership. The Director POL is expected to operate with autonomy and high‑degree of independence.
In a typical day, you will:
- Be responsible for the overall success of the clinical study team(s) within a program(s).
- Maintain an overview of clinical program(s) status and issues and proactively communicate progress, risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level updates to stakeholders as requested.
- Provide operational insight into feasibility, timeline and cost estimates during clinical program/study development.
- Oversee clinical study timelines within a clinical program(s).
- Provide input and operational insight into Clinical Study Concepts (CSC).
- Be responsible for development and implementation of operational strategy, driving early study planning budget and timelines from Clinical Study Concept through Final Protocol Review plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases of studies.
- Ensure consistency within the program and development of best practices within CTM.
- Oversee clinical study budgets within a program: ensures review, presentation and approval of initial study budget and manages the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriate.
- Ensure timely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s).
- Drive decision making and integrates all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation.
- Act as point of contact for clinical program and study level escalation.
- Review key metrics and Key Performance Indicators (KPIs) across studies and within clinical program(s) to track study progress.
- Provide proactive creation and implementation of risk mitigation strategies.
- Provide innovative and flexible operational solutions and options to the cross functional and development teams; assists in preparing scenarios for creative solutions to operational challenges.
- Drives the strategy and oversight for vendor selection and management within a clinical program(s).
- Manages the Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level deliverables and relationship with key CRO (functional and project) and vendor counterparts.
- May require up to 25% travel.
Requirements
To be considered, you must possess a Bachelor's degree and a minimum of 12 years of related in‑house sponsor‑side pharmaceutical experience, with 8 years in clinical operations.
Director, Program Operations Leader - Ophthalmology/Renal in Uxbridge employer: Regeneron
Regeneron is an exceptional employer that fosters a collaborative and innovative work culture, particularly in the dynamic field of clinical trial management. With a hybrid work model based in Uxbridge, employees benefit from a balanced approach to work-life integration, alongside ample opportunities for professional growth and development through mentorship and leadership roles. The company prioritises quality and operational excellence, ensuring that team members are empowered to drive impactful clinical research while enjoying a supportive environment that values diversity and inclusion.
StudySmarter Expert Advice🤫
We think this is how you could land Director, Program Operations Leader - Ophthalmology/Renal in Uxbridge
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who work in clinical operations. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by researching the company and its recent projects. Show them you’re not just another candidate; you’re genuinely interested in their work and how you can contribute to their success.
✨Tip Number 3
Practice your pitch! Be ready to explain how your experience aligns with the role of Program Operations Leader. Highlight your leadership skills and how you've successfully managed clinical trials in the past.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take that extra step to connect with us directly.
We think you need these skills to ace Director, Program Operations Leader - Ophthalmology/Renal in Uxbridge
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of Director, Program Operations Leader. Highlight your experience in clinical operations and any leadership roles you've held. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this position. Share specific examples of your achievements in clinical trial management that demonstrate your ability to lead complex programmes.
Showcase Your Leadership Skills:As a POL, you'll be leading teams and managing budgets. Make sure to highlight your leadership experience and any successful projects you've overseen. We love seeing how you’ve driven success in previous roles!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application 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 Stuff
Make sure you’re well-versed in the specifics of clinical trial management and the operational strategies relevant to ophthalmology and renal programmes. Brush up on ICH/GCP regulations and company SOPs, as these will likely come up during your chat.
✨Show Leadership Skills
As a Director, you'll need to demonstrate your ability to lead teams effectively. Prepare examples of how you've successfully managed clinical operations, mentored staff, and driven strategic initiatives in previous roles. This will show that you can operate with autonomy and independence.
✨Be Ready for Scenario Questions
Expect questions that ask how you would handle specific challenges in clinical operations. Think about potential risks, budget management, and timeline issues. Having a few scenarios prepared will help you showcase your problem-solving skills and operational insight.
✨Engage with Stakeholders
Since the role involves interaction with senior management and external vendors, be prepared to discuss how you’ve effectively communicated with various stakeholders in the past. Highlight your experience in providing updates and managing expectations, as this is crucial for the role.
