At a Glance
- Tasks: Lead complex clinical programs and ensure successful delivery of clinical research studies.
- Company: Join Regeneron, a leader in innovative pharmaceutical solutions.
- Benefits: Comprehensive health benefits, 401(k) match, paid time off, and equity awards.
- Other info: Collaborative culture with opportunities for professional growth and development.
- Why this job: Make a real impact in clinical operations and drive innovative healthcare solutions.
- Qualifications: Bachelor's degree with 12+ years in pharmaceutical experience and 8+ years in clinical operations.
The predicted salary is between 80000 - 100000 £ per year.
The Director 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 integrate 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; assist in preparing scenarios for creative solutions to operational challenges.
- Drive the strategy and oversight for vendor selection and management within a clinical program(s).
- Manage 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.
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.
A fully remote role is NOT possible for this position.
Director Program Operations Leader, Internal Medicines in Uxbridge employer: Regeneron Pharmaceuticals
Regeneron is an exceptional employer that fosters a collaborative and inclusive work culture, providing comprehensive benefits tailored to support employee well-being and professional growth. With a strong emphasis on mentorship and development, employees in the Director Program Operations Leader role can expect to thrive in a dynamic environment that values innovation and operational excellence, all while contributing to meaningful advancements in clinical research.
StudySmarter Expert Advice🤫
We think this is how you could land Director Program Operations Leader, Internal Medicines in Uxbridge
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage with professionals on platforms like LinkedIn. We all know that sometimes it's not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values and how they align with your own. We want you to shine, so practice common interview questions and think about how your experience fits the role of Director Program Operations Leader.
✨Tip Number 3
Showcase your leadership skills! As a potential Director, you'll need to demonstrate your ability to manage teams and drive projects. Share specific examples from your past experiences where you've successfully led initiatives or improved processes.
✨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 our team. So, take that step and submit your application today!
We think you need these skills to ace Director Program Operations Leader, Internal Medicines in Uxbridge
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter to highlight your experience in clinical operations and program management. We want to see how your skills align with the Director Program Operations Leader role, so don’t hold back on showcasing your relevant achievements!
Showcase Leadership Skills:As a POL, you'll be leading teams and managing projects. Use your application to demonstrate your leadership experience, especially in clinical trial management. Share examples of how you've successfully guided teams through challenges and achieved project goals.
Be Clear and Concise:When writing your application, clarity is key! Keep your language straightforward and avoid jargon unless it's industry-specific. We appreciate a well-structured application that gets straight to the point while still reflecting your personality.
Apply Through Our Website:We encourage you to apply directly through our website for the best chance of being noticed. It’s super easy, and you’ll be able to track your application status. Plus, it shows us you’re genuinely interested in joining our team!
How to prepare for a job interview at Regeneron Pharmaceuticals
✨Know Your Stuff
Make sure you’re well-versed in the specifics of clinical trial management and operational strategies. Brush up on ICH/GCP regulations and company SOPs, as these will likely come up during your interview. Being able to discuss how you've applied these in past roles will show you're the right fit.
✨Showcase Leadership Skills
As a Director POL, you'll be leading teams and managing staff. Prepare examples that highlight your leadership style, how you've developed and mentored team members, and how you've driven successful outcomes in previous projects. This will demonstrate your capability to lead effectively.
✨Be Ready for Scenario Questions
Expect questions that ask how you would handle specific challenges in clinical operations. Think about potential risks in clinical studies and how you would mitigate them. Having a few scenarios prepared will help you articulate your problem-solving skills and operational insight.
✨Engage with Questions
Prepare thoughtful questions to ask your interviewers about their current projects, team dynamics, and the company's vision for clinical trial management. This shows your genuine interest in the role and helps you assess if the company culture aligns with your values.
