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.
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 employer: Orchard Therapeutics - U.S.
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 mentorship and development opportunities, ensuring that our teams are equipped to excel in their roles while contributing to groundbreaking clinical trials. With a strong commitment to quality and compliance, we foster a culture of excellence that empowers our employees to make a meaningful impact in the field of clinical operations and data management.
Contact Detail:
Orchard Therapeutics - U.S. Recruiting Team
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 biotech and pharma sectors. Attend industry events or webinars, and don’t be shy about introducing yourself. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its recent projects. Tailor your responses to highlight your experience in clinical operations and data management. Show them how your skills align with their goals, especially in managing CROs and ensuring compliance with global regulations.
✨Tip Number 3
Don’t just apply and wait! Follow up on your applications through our website. A quick email expressing your enthusiasm can set you apart from other candidates. It shows you're proactive and genuinely interested in the role.
✨Tip Number 4
Practice your leadership stories! Be ready to discuss how you've led teams and managed projects in fast-paced environments. Use specific examples that demonstrate your problem-solving skills and ability to drive cross-functional collaboration.
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 any relevant experience with CROs or regulatory requirements to catch our eye!
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. Share your passion for clinical trials and how your background aligns with our mission at StudySmarter.
Showcase Your Achievements:Don’t just list your responsibilities; showcase your achievements! Use metrics where possible to demonstrate how you’ve successfully led clinical studies on time and within budget. We love numbers that tell a story!
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, it shows us you’re keen on joining the StudySmarter team!
How to prepare for a job interview at Orchard Therapeutics - U.S.
✨Know Your Clinical Operations Inside Out
Make sure you brush up on your knowledge of clinical operations and data management. Understand the key elements of ICH-GCP and be ready to discuss how you've applied these principles in your previous roles. This will show that you're not just familiar with the theory, but that you can also implement it effectively.
✨Showcase Your Leadership Skills
As a VP, you'll need to demonstrate strong leadership capabilities. Prepare examples of how you've led teams through challenging projects or managed cross-functional collaborations. Highlight your experience in mentoring and developing high-performing teams, as this is crucial for the role.
✨Be Ready to Discuss Budget Management
Since overseeing study budgets is a key responsibility, come prepared to talk about your experience managing budgets and resources. Share specific examples of how you've successfully delivered projects on time and within budget, and be ready to discuss any challenges you faced and how you overcame them.
✨Understand the Regulatory Landscape
Familiarise yourself with global regulatory requirements and be prepared to discuss your experience with regulatory submissions. This includes IRB/ethics committees and local authorities. Showing that you have a solid understanding of compliance will reassure the interviewers that you can maintain high-quality standards in clinical trials.
