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- Tasks: Lead complex clinical programs and ensure successful delivery of clinical research studies.
- Company: Join a leading pharmaceutical company dedicated to innovative medicine.
- Benefits: Comprehensive health benefits, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact in rare disease research while working with top professionals.
- Qualifications: Bachelor's degree and extensive experience in clinical operations required.
- Other info: Collaborative environment with a focus on inclusivity and career development.
The predicted salary is between 43200 - 72000 £ 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.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way!
We have an inclusive culture that provides comprehensive benefits, which vary by location.
Director Program Operations Leader, Specialty Medicine, Rare Disease in Newry employer: Regeneron Pharmaceuticals
Contact Detail:
Regeneron Pharmaceuticals Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director Program Operations Leader, Specialty Medicine, Rare Disease in Newry
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who work at Regeneron or similar companies. A friendly chat can open doors and give you insider info that could help you stand out.
✨Tip Number 2
Prepare for interviews by diving deep into the company’s culture and values. Show us how your experience aligns with the role of Director Program Operations Leader and be ready to discuss specific examples from your past that highlight your leadership skills.
✨Tip Number 3
Don’t just wait for job postings! Be proactive and reach out directly through our website. Express your interest in the role and share how you can contribute to the team’s success in clinical trial management.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can leave a lasting impression. Use this opportunity to reiterate your enthusiasm for the position and remind us why you’re the perfect fit for the Director role.
We think you need these skills to ace Director Program Operations Leader, Specialty Medicine, Rare Disease in Newry
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Director Program Operations Leader role. Highlight your experience in clinical trial management and operational strategy, as well as 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 passionate about specialty medicine and rare diseases. Share specific examples of how you've successfully managed complex programmes and led teams in the past. Let us know why you’re the perfect fit for this role!
Showcase Your Leadership Skills: As a Director, you'll be leading teams and making key decisions. Make sure to highlight your leadership experience in your application. Talk about how you've coached and developed staff, and how you've driven successful outcomes in previous roles. We love to see strong leaders!
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, you’ll find all the details about the role and our company culture there. Don’t miss out on this opportunity!
How to prepare for a job interview at Regeneron Pharmaceuticals
✨Know Your Stuff
Make sure you have a solid understanding of clinical trial management and the specific responsibilities of the Director Program Operations Leader role. Brush up on ICH/GCP regulations and company SOPs, as these will likely come up during your interview.
✨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 of scenarios where you've had to implement risk mitigation strategies or innovative solutions in clinical operations. This will demonstrate your ability to drive decision-making and manage challenges effectively.
✨Engage with Stakeholders
Since this role involves interaction with senior management and external vendors, prepare to discuss how you've successfully communicated progress and issues in past projects. Highlight your experience in maintaining relationships and providing updates to stakeholders.
