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- Tasks: Lead and manage clinical trials for innovative gene therapies in ophthalmic diseases.
- Company: Join a pioneering European biotech firm focused on transforming eye care through cutting-edge research.
- Benefits: Enjoy competitive salary, flexible working options, and opportunities for professional growth.
- Why this job: Be at the forefront of medical innovation and make a real impact on patients' lives.
- Qualifications: 10+ years in clinical operations, with strong leadership and project management skills required.
- Other info: This is a key leadership role with significant influence on trial design and execution.
The predicted salary is between 72000 - 108000 £ per year.
ARTO is currently partnered with an early stage, European biotechnology company specialising in Ophthalmic diseases using innovative Gene Therapies. With upcoming Phase I clinical trials, they are searching for an experienced Clinical Operations leader to drive these first in human studies. As Head of Clinical Operations, you’ll be responsible for overseeing the planning, execution, and delivery of our clinical trials. You’ll work closely with cross-functional teams and senior leadership to ensure our programs are designed and run efficiently and also meet regulatory requirements. This is a key leadership role.
Key Responsibilities
- Lead the development and execution of clinical operations strategy across all programs.
- Oversee all aspects of clinical trial management, including site selection, vendor oversight, patient recruitment, monitoring, and study close-out.
- Build and manage a high-performing Clinical Operations team.
- Partner with Clinical Development, Regulatory and Quality to ensure alignment on trial design and execution.
- Ensure trials are conducted in compliance with GCP, regulatory requirements, and company SOPs.
- Cultivate strong relationships with investigators, CROs, and other external partners.
- Serve as a key point of contact during regulatory inspections and audits.
Qualifications
- 10+ years of clinical operations experience in biotech or pharma, with at least 5 years in a leadership role.
- Proven track record of successfully leading Phase I and II clinical trials.
- Deep understanding of ICH-GCP, FDA regulations, and international clinical research guidelines.
- Strong leadership skills with the ability to build, mentor, and inspire a growing team.
- Excellent project management, organizational, and communication skills.
- Comfortable operating in a fast-paced, dynamic environment with evolving priorities.
Head of Clinical Operations employer: ARTO
Contact Detail:
ARTO Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Head of Clinical Operations
✨Tip Number 1
Network with professionals in the biotechnology and clinical operations fields. Attend industry conferences, webinars, and local meetups to connect with potential colleagues and leaders who can provide insights or even referrals for the Head of Clinical Operations role.
✨Tip Number 2
Stay updated on the latest trends and advancements in gene therapies and ophthalmic diseases. This knowledge will not only enhance your conversations during interviews but also demonstrate your genuine interest and commitment to the field.
✨Tip Number 3
Prepare to discuss your leadership style and experiences in managing clinical trials. Be ready to share specific examples of how you've successfully led teams and navigated challenges in previous roles, particularly in Phase I and II trials.
✨Tip Number 4
Familiarise yourself with the regulatory landscape relevant to the role, including ICH-GCP and FDA regulations. Being able to speak confidently about compliance and quality assurance will set you apart as a strong candidate for this key leadership position.
We think you need these skills to ace Head of Clinical Operations
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in clinical operations, particularly in biotech or pharma. Emphasise your leadership roles and any successful Phase I and II trials you've led.
Craft a Compelling Cover Letter: In your cover letter, express your passion for ophthalmic diseases and gene therapies. Discuss how your background aligns with the responsibilities of the Head of Clinical Operations role and your vision for leading clinical trials.
Highlight Regulatory Knowledge: Given the importance of compliance in this role, ensure you mention your understanding of ICH-GCP, FDA regulations, and international clinical research guidelines. Provide examples of how you've navigated these in past roles.
Showcase Leadership Skills: Illustrate your leadership abilities by sharing specific examples of how you've built and managed high-performing teams. Highlight your mentoring experiences and how you've inspired others in a fast-paced environment.
How to prepare for a job interview at ARTO
✨Showcase Your Leadership Experience
As a candidate for the Head of Clinical Operations, it's crucial to highlight your leadership experience. Prepare specific examples of how you've successfully led teams in previous roles, particularly in clinical trial settings. This will demonstrate your capability to build and manage a high-performing team.
✨Understand Regulatory Requirements
Familiarise yourself with ICH-GCP, FDA regulations, and international clinical research guidelines. Be ready to discuss how you have ensured compliance in past trials. This knowledge is essential for the role and will show that you are well-prepared for the responsibilities ahead.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills in clinical operations. Think about challenges you've faced in previous trials and how you overcame them. This will help you illustrate your project management and organisational skills effectively.
✨Cultivate Relationships
Since building strong relationships with investigators, CROs, and external partners is key, be prepared to discuss your approach to stakeholder management. Share examples of how you've successfully collaborated with various teams and external partners to achieve trial objectives.
