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For Companies At a Glance
- Tasks: Lead complex clinical programs and ensure successful delivery of clinical research studies.
- Company: Join a leading biopharmaceutical 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 culture with a focus on inclusivity and career development.
The predicted salary is between 54000 - 90000 £ 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 communicates 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 integrates 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.
- Drives the strategy and oversight for vendor selection and management within a clinical program(s).
- Manages 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.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.
Director Program Operations Leader, Specialty Medicine, Rare Disease in Cambridge 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 Cambridge
✨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 on the role.
✨Tip Number 2
Prepare for interviews by diving deep into the company’s culture and values. Show us how your experience aligns with the Regeneron Way and be ready to discuss how you can contribute to their mission.
✨Tip Number 3
Practice your pitch! Be clear about your achievements and how they relate to the Director Program Operations Leader role. We want to hear how you’ve tackled challenges and driven success in clinical operations.
✨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 serious about joining the team at Regeneron.
We think you need these skills to ace Director Program Operations Leader, Specialty Medicine, Rare Disease in Cambridge
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 operations and 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. Let us know how your skills can drive our operational strategy forward.
Showcase Your Leadership Skills: As a POL, you'll be leading teams and managing projects. Be sure to include examples of how you've successfully led teams or managed complex projects in your application. We love seeing those leadership qualities!
Apply Through Our Website: Don't forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy to do!
How to prepare for a job interview at Regeneron Pharmaceuticals
✨Know Your Program Inside Out
Before the interview, dive deep into the specifics of the clinical programs you’ll be managing. Understand the operational strategies, timelines, and budgets that are crucial for success. This will not only show your expertise but also demonstrate your commitment to the role.
✨Showcase Leadership Skills
As a Director POL, you'll be leading teams and making critical decisions. Prepare examples from your past experiences where you've successfully managed teams, resolved conflicts, or driven projects to completion. Highlight your coaching and mentoring abilities to illustrate how you can develop your staff.
✨Be Ready for Scenario Questions
Expect questions that ask how you would handle specific challenges in clinical trial management. Think about potential risks and how you would mitigate them, or how you would ensure quality and compliance. Practising these scenarios will help you articulate your thought process clearly.
✨Understand the Company Culture
Research Regeneron’s values and culture, especially their emphasis on collaboration and inclusivity. Be prepared to discuss how your personal values align with theirs and how you can contribute to fostering a positive work environment. This will show that you’re not just a fit for the role, but for the company as well.
