At a Glance
- Tasks: Lead global clinical trials, ensuring quality and compliance while managing budgets and timelines.
- Company: Join Orchard Therapeutics, a pioneering biotech firm focused on innovative therapies.
- Benefits: Competitive salary, professional development, and a dynamic work environment.
- Other info: Opportunity to work with cutting-edge therapies and mentor high-performing teams.
- Why this job: Make a real impact in the biotech field and advance your career in clinical operations.
- Qualifications: Extensive experience in clinical operations and strong leadership skills required.
The predicted salary is between 100000 - 150000 £ per year.
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 London employer: Meeveem Limited
Orchard Therapeutics is an exceptional employer, offering a dynamic work environment in London that fosters innovation and collaboration in the biotech sector. With a strong commitment to employee development, we provide ample opportunities for growth and mentorship, ensuring our teams are equipped to lead high-quality clinical trials that make a meaningful impact on patients' lives. Our inclusive culture prioritises integrity and excellence, making Orchard Therapeutics a rewarding place to advance your career in clinical operations and data management.
StudySmarter Expert Advice🤫
We think this is how you could land VP, Clinical Operations and Data Management London
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We think you need these skills to ace VP, Clinical Operations and Data Management London
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Meeveem Limited!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Meeveem Limited that you're not just a fit for the job but also a safety-conscious candidate!
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