At a Glance
- Tasks: Lead complex clinical trial programs and ensure operational excellence.
- 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 with 12+ years in pharmaceutical operations 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.
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 London 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 and the chance to lead impactful clinical programs in Oncology. Our supportive culture, combined with flexible working arrangements, ensures that you can achieve a healthy work-life balance while contributing to groundbreaking research.
StudySmarter Expert Advice🤫
We think this is how you could land Director Program Operations Leader, Oncology in London
✨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 us that you’re not just another candidate; demonstrate your passion for oncology and how your experience aligns with their goals.
✨Tip Number 3
Practice your pitch! Be ready to explain how your leadership style and operational strategies can drive success in clinical trials. We want to hear how you can make an impact right from the start.
✨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 us you’re genuinely interested in being part of our team.
We think you need these skills to ace Director Program Operations Leader, Oncology in London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the specific skills and experiences that align with the Director Program Operations Leader role. Highlight your leadership in clinical operations and any relevant achievements that demonstrate your ability to manage complex programmes.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to tell us why you're passionate about oncology and how your experience makes you the perfect fit for this role. Be sure to mention your understanding of clinical trial management and operational strategy.
Showcase Your Leadership Skills:As a POL, you'll be leading teams and driving strategies. In your application, emphasise your experience in managing teams, mentoring staff, and making impactful decisions. We want to see how you've successfully led projects in the past!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us you're serious about joining our team at StudySmarter!
How to prepare for a job interview at Regeneron
✨Know Your Stuff
Make sure you thoroughly understand the role of a Director Program Operations Leader in Oncology. Brush up on clinical trial management, ICH/GCP regulations, and the specific operational strategies that are crucial for success in this position.
✨Showcase Leadership Skills
Prepare examples that highlight your leadership experience, especially in managing clinical operations teams. Be ready to discuss how you've successfully recruited, developed, and mentored staff in previous roles.
✨Be Proactive with Problem-Solving
Think about potential challenges that might arise in clinical program management and come prepared with innovative solutions. This shows that you can think ahead and are ready to tackle issues before they escalate.
✨Engage with Stakeholders
Since the role involves interaction with senior management and external vendors, practice how you would communicate updates and manage relationships. Highlight your experience in stakeholder engagement and how you ensure alignment across teams.