At a Glance
- Tasks: Lead complex clinical trial programs and ensure operational success.
- Company: Join a leading pharmaceutical company dedicated to innovative oncology solutions.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Collaborative environment with opportunities for mentorship and career development.
- Why this job: Make a real impact in clinical research and drive advancements in oncology.
- Qualifications: Bachelor's degree and extensive experience in clinical operations required.
The predicted salary is between 80000 - 120000 € 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.
For US Locations, this position is on‑site 4 days per week and 1 day from home. For Uxbridge and Dublin, colleagues must be on‑site 3 days per week and 2 days from home. A fully remote role is NOT possible for this position.
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; assists 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.
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, Oncology in Uxbridge employer: Regeneron
Regeneron is an exceptional employer, offering a dynamic work environment where innovation and collaboration thrive. With a strong commitment to employee development, you will have access to numerous growth opportunities while working alongside industry leaders in the heart of Uxbridge or Dublin. Enjoy a balanced work-life culture with flexible remote options, competitive benefits, and the chance to make a meaningful impact in the field of oncology clinical research.
StudySmarter Expert Advice🤫
We think this is how you could land Director Program Operations Leader, Oncology 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 Director Program Operations Leader. Highlight your leadership skills and how you've successfully managed complex clinical programs 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 are proactive about their job search.
We think you need these skills to ace Director Program Operations Leader, Oncology in Uxbridge
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Director Program Operations Leader role. Highlight your experience in clinical operations and how it aligns with the responsibilities mentioned in the job description. We want to see how you can bring your unique skills to our team!
Showcase Leadership Experience:Since this role involves leading teams and managing staff, be sure to emphasise your leadership experience. Share specific examples of how you've successfully managed projects or teams in the past. We love hearing about your journey and how you’ve driven success!
Be Clear and Concise:When writing your application, keep it clear and to the point. Use bullet points where possible to make it easy for us to read. We appreciate a well-structured application that highlights your key achievements without unnecessary fluff!
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 gives you a chance to explore more about what we do at StudySmarter!
How to prepare for a job interview at Regeneron
✨Know Your Clinical Operations Inside Out
Make sure you brush up on your knowledge of clinical trial management, especially in oncology. Be ready to discuss specific strategies you've implemented in past roles that align with the operational strategy for complex programmes.
✨Showcase Your Leadership Skills
As a Director POL, you'll be leading teams and managing staff. Prepare examples of how you've successfully recruited, developed, and mentored team members in previous positions. Highlight your ability to drive functional strategy and decision-making.
✨Be Ready to Discuss Budgets and Timelines
Since budget management and timeline oversight are crucial for this role, come prepared with examples of how you've managed these aspects in past projects. Be specific about the challenges you faced and how you overcame them.
✨Prepare for Scenario-Based Questions
Expect questions that require you to think on your feet. Practice responding to hypothetical scenarios related to risk mitigation and operational challenges in clinical trials. This will demonstrate your problem-solving skills and innovative thinking.
