At a Glance
- Tasks: Lead global clinical trials and ensure high-quality, compliant studies.
- Company: Dynamic biotech firm focused on innovative therapies.
- 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 advancing clinical development and patient care.
- 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.
Requirements
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 in London employer: Orchard Therapeutics
As a leading player in the biotech sector, our London-based company offers an exceptional work environment that fosters innovation and collaboration. We prioritise employee growth through continuous learning opportunities and mentorship, ensuring that our team is equipped to excel in their roles. With a strong commitment to patient-focused research and a culture that values integrity and excellence, we provide a rewarding career path for those passionate about making a difference in clinical operations and data management.
StudySmarter Expert Advice🤫
We think this is how you could land VP, Clinical Operations and Data Management in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical operations and data management field. Attend industry events or webinars, and don’t be shy about introducing yourself to key players. You never know who might have the inside scoop on job openings!
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ICH-GCP and global regulatory requirements. Be ready to discuss your experience with managing CROs and external vendors. Show them you’re not just a fit for the role, but that you can lead teams to success!
✨Tip Number 3
Don’t forget to showcase your problem-solving skills! During interviews, share specific examples of how you’ve tackled challenges in clinical trials. This will demonstrate your ability to operate strategically and tactically, which is crucial for a VP role.
✨Tip Number 4
Apply through our website! We want to see your application come through directly. It shows initiative and gives us a chance to connect with you right away. Plus, it’s a great way to stay updated on any new opportunities that pop up!
We think you need these skills to ace VP, Clinical Operations and Data Management in London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the specific skills and experiences that align with the VP, Clinical Operations and Data Management role. Highlight your leadership in clinical trials and any relevant experience in biotech or pharma.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to tell us why you're passionate about clinical operations and how your background makes you the perfect fit for our team. Be sure to mention any experience with CROs and regulatory requirements.
Showcase Your Leadership Skills:We want to see how you've led teams and managed projects in the past. Include examples of how you've driven cross-functional collaboration and delivered high-quality studies on time and within budget.
Apply Through Our Website:Don't forget to submit your application through our website! It’s the best way for us to receive your materials and ensures you’re considered for the role. We can’t wait to hear from you!
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 cross-functional collaboration. Think of specific situations where you successfully led a project or resolved a critical issue.
✨Budget Savvy
Be ready to talk about your experience with budget management and resource planning. Have concrete examples of how you’ve kept projects on track financially while ensuring high-quality outcomes.
✨Build Relationships
Demonstrate your ability to build strong relationships with stakeholders, investigators, and vendors. Share stories that illustrate your communication skills and how you’ve fostered collaboration in past roles.
