At a Glance
- Tasks: Lead complex clinical programs and ensure successful delivery of clinical research studies.
- Company: Join a leading pharmaceutical company focused on innovative healthcare solutions.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: On-site work with flexible remote options and potential travel.
- Why this job: Make a real impact in clinical research while working with a dynamic team.
- Qualifications: Bachelor's degree and extensive experience in clinical operations required.
The predicted salary is between 72000 - 108000 € per year.
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.
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 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.
Director, Program Operations Leader - Ophthalmology/Renal in Cambridge employer: Regeneron Pharmaceuticals, Inc
As a leading employer in the pharmaceutical sector, we offer a dynamic work environment that fosters innovation and collaboration. Our commitment to employee development is evident through comprehensive training programs and mentorship opportunities, ensuring that our team members grow alongside the company. With a flexible work arrangement of three days on-site and two days remote for our Uxbridge and Dublin locations, we promote a healthy work-life balance while driving impactful clinical research initiatives.
Contact Detail:
Regeneron Pharmaceuticals, Inc Recruiting Team
StudySmarter Expert Advice🤫
We think this is how you could land Director, Program Operations Leader - Ophthalmology/Renal in Cambridge
✨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 culture. Understand their clinical trial management processes and be ready to discuss how your experience aligns with their operational strategies.
✨Tip Number 3
Showcase your leadership skills during interviews. Talk about your experience in managing teams and driving successful clinical studies. Highlight specific examples where you’ve made a difference in timelines or budgets.
✨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 - Ophthalmology/Renal in Cambridge
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of Program Operations Leader. Highlight your experience in clinical operations, especially any leadership roles you've had. We want to see how your background aligns with the responsibilities outlined in the job description.
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. Mention specific experiences that relate to managing clinical trials and leading teams, as well as your understanding of ICH/GCP regulations.
Showcase Your Leadership Skills:Since this role involves line management and mentoring, be sure to highlight your leadership skills. Share examples of how you've successfully led teams or projects in the past, and how you can bring that expertise to our Clinical Trial Management team.
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you receive updates directly from us. Plus, it shows you're keen on joining our team!
How to prepare for a job interview at Regeneron Pharmaceuticals, Inc
✨Know Your Clinical Operations Inside Out
Make sure you brush up on your knowledge of clinical trial management, especially in ophthalmology and renal fields. Be prepared to discuss specific examples from your past experience that demonstrate your ability to lead complex programmes and manage budgets effectively.
✨Showcase Your Leadership Skills
As a Director, you'll need to exhibit strong leadership qualities. Prepare to share instances where you've successfully managed teams, mentored staff, or driven strategic initiatives. Highlight how you foster collaboration and communication among cross-functional teams.
✨Be Ready for Scenario-Based Questions
Expect questions that assess your problem-solving skills and operational insight. Think about potential challenges in clinical operations and how you would address them. Practising these scenarios can help you articulate your thought process clearly during the interview.
✨Understand the Company’s Culture and Values
Research the company’s mission and values, especially regarding their approach to clinical research. Be ready to discuss how your personal values align with theirs and how you can contribute to their goals, particularly in driving quality and innovation in clinical trials.
