At a Glance
- Tasks: Lead global clinical trials, ensuring quality and compliance while managing budgets and timelines.
- Company: Dynamic biotech firm focused on innovative therapies and patient-centric solutions.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Fast-paced environment with a focus on rare diseases and cutting-edge therapies.
- Why this job: Make a real impact in clinical operations and contribute to groundbreaking medical advancements.
- Qualifications: Extensive experience in clinical operations and strong leadership skills required.
The predicted salary is between 100000 - 150000 € per year.
Reporting to: Chief Medical Officer
Location: London
Job Summary
The Vice President of Clinical Operations and Data Management (CODM) provides strategic leadership for the planning, execution, and oversight of global clinical trials. This role is accountable for delivering high-quality, compliant, patient-focused studies on time and within budget, while advancing the organization’s clinical development strategy and supporting global regulatory and commercialization objectives.
Key Elements and Responsibilities
- Provide strategic and operational leadership for clinical operations and data management across programs, from study start-up through close-out, in compliance with ICH-GCP.
- Ensure the quality, integrity, and inspection-readiness of all clinical and data management activities globally.
- Drive cross-functional collaboration to deliver clinical trials on time and within budget.
- Lead planning, execution, and reporting of clinical studies, ensuring alignment on timelines, deliverables, and resources.
- Act as the primary escalation point for critical study and vendor issues.
- Oversee study budgets, timelines, resources, and financial tracking.
- Partner with Clinical Science, Biostatistics, and external vendors to ensure seamless delivery of clinical documentation and data management activities.
- Ensure effective coordination of regulatory submissions (e.g., IRB/ethics committees, local authorities).
- Oversee data management strategy and execution, including database design, build, maintenance, and database lock activities, in alignment with biostatistics.
- Ensure robust data integrity, accurate record-keeping, and compliant archiving practices.
- Provide oversight of clinical sites, academic partners, and vendors (e.g., CROs, labs) to ensure performance, quality, and compliance.
- Build and maintain strong relationships with investigators and key opinion leaders.
- Lead, develop, and mentor high-performing teams.
- Ensure delivery of high-quality study documentation to meet program timelines.
Experience, Skills & Knowledge
- Extensive experience in clinical operations leadership within biotech/pharma.
- Strong clinical project and program management expertise.
- Proven track record managing CROs and external vendors.
- Solid understanding of global regulatory requirements (ICH-GCP).
- Experience managing budgets and resource planning.
- Strong problem-solving skills with the ability to operate strategically and tactically.
- Excellent leadership, communication, and stakeholder management skills.
- Ability to thrive in a fast-paced, evolving biotech environment.
- Experience in rare/orphan diseases and/or academic collaborations is a plus.
Education
- Bachelor’s degree in Life Sciences required.
- Advanced degree (MS, PhD, or equivalent) preferred.
- Substantial experience leading Clinical Operations and Data Management teams.
- Experience in rare disease; gene and cell therapy experience is a plus.
VP, Clinical Operations and Data Management employer: Orchard Therapeutics
As a leading player in the biotech sector, our company offers an exceptional work environment in London, where innovation meets collaboration. We prioritise employee growth through continuous learning opportunities and mentorship, fostering a culture that values integrity and excellence in clinical operations. Join us to be part of a dynamic team dedicated to advancing patient-focused studies while enjoying competitive benefits and a supportive workplace.
StudySmarter Expert Advice🤫
We think this is how you could land VP, Clinical Operations and Data Management
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical operations and data management field. Attend industry events, webinars, or even local meet-ups to make those valuable contacts that could lead to your next big opportunity.
✨Tip Number 2
Prepare for interviews by researching the company and its recent projects. Show them you’re not just another candidate; demonstrate your passion for their mission and how your experience aligns with their goals in clinical trials and data management.
✨Tip Number 3
Practice your pitch! You need to be able to clearly articulate your experience in managing clinical operations and working with CROs. Make sure you can highlight your leadership skills and problem-solving abilities in a way that resonates with the interviewers.
✨Tip Number 4
Don’t forget to apply through our website! We’ve got some fantastic opportunities waiting for you, and applying directly can sometimes give you an edge. Plus, it shows you’re genuinely interested in being part of our team!
We think you need these skills to ace VP, Clinical Operations and Data Management
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the specific skills and experiences mentioned in the job description. Highlight your leadership in clinical operations and data management, and don’t forget to showcase any relevant experience with CROs and regulatory requirements.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for the VP role. Mention your strategic vision for clinical trials and how your past experiences align with our goals at StudySmarter.
Showcase Your Problem-Solving Skills:In your application, give examples of how you've tackled challenges in clinical operations. We want to see your ability to think strategically and tactically, especially in fast-paced environments like biotech.
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 this exciting opportunity at StudySmarter!
How to prepare for a job interview at Orchard Therapeutics
✨Know Your Stuff
Make sure you’re well-versed in the latest trends and regulations in clinical operations and data management. Brush up on ICH-GCP guidelines and be ready to discuss how you've applied them in your previous roles.
✨Showcase Your Leadership Skills
Prepare examples that highlight your leadership experience, especially in managing teams and driving cross-functional collaboration. Think of specific instances where you successfully led a project or resolved a critical issue.
✨Be Budget Savvy
Since this role involves overseeing study budgets, come prepared with insights on how you’ve managed budgets in the past. Be ready to discuss your approach to financial tracking and resource planning.
✨Build Relationships
Emphasise your ability to build strong relationships with investigators and key opinion leaders. Share examples of how you’ve fostered collaboration with external vendors and academic partners to ensure successful trial outcomes.
