At a Glance
- Tasks: Lead clinical operations and oversee the execution of innovative clinical trials.
- Company: Join Draig Therapeutics, a pioneering biotech focused on neuropsychiatric disorders.
- Benefits: Competitive salary, remote work options, and a collaborative culture.
- Other info: Dynamic environment with opportunities for continuous improvement and career growth.
- Why this job: Make a real impact in a new biotech company with cutting-edge research.
- Qualifications: 10+ years in clinical operations with strong leadership and problem-solving skills.
The predicted salary is between 72000 - 108000 € per year.
The Director of Clinical Operations will lead the clinical operations function at Draig Therapeutics. This is a hands-on role, responsible for overseeing the planning, execution, and delivery of clinical trials through a fully outsourced model to ensure successful planning, execution, management and oversight of all clinical trial operations.
Draig Therapeutics is focused on developing medicines to address unmet medical needs in neuropsychiatric disorders by developing highly targeted neuromodulators that redefine the known treatment paradigm. The company has recently launched in stealth mode and is advancing a multi-asset pipeline, with the lead asset completing Phase 1 and preparing for Phase 2.
Role Summary
This role holds a low level requirement of domestic and/or international travel, as directed by business needs to proactively identify and resolve site-level issues. The ideal candidate will bring extensive experience in clinical operations, a strategic mindset, and a hands-on approach to drive our clinical programs forward.
Key Responsibilities
- Leadership and Management: Lead a small clinical operations team consisting of Clinical Operations Leads and Assistant Project Managers, fostering a collaborative and high-performance culture.
- Clinical Trial Oversight: Oversee the planning, initiation, execution, and close-out of clinical trials. Ensure trials are conducted in compliance with regulatory requirements, Good Clinical Practice (GCP), and company SOPs. May act as a Clinical Lead as required.
- Vendor Management: Manage and oversee Clinical Contract Research Organizations (CROs). Ensure high-quality deliverables and adherence to timelines and budgets.
- Regulatory Compliance: Ensure all clinical activities comply with relevant regulatory requirements. Review and provide clinical operations content to clinical and regulatory documents. Review regulatory documents as designated by the CMO.
- Budget Management: Develop and manage clinical trial budgets. Monitor expenditures and ensure cost-effective use of resources.
- Risk Management: Identify potential risks in clinical trials and develop mitigation strategies. Ensure proactive problem-solving and issue resolution.
- Patient Recruitment: Develop and implement strategies for patient recruitment and retention. Collaborate with clinical sites to ensure timely enrolment.
- Data Management: Oversee data collection, management, and analysis. Ensure data integrity and quality throughout the trial process.
- Stakeholder Communication: Serve as the primary point of contact for clinical operations for internal and external stakeholders. Provide regular updates on trial progress and key milestones.
- Investigator relations: Establish and maintain strong relationships with investigative sites to support enrolment, build engagement, and proactively address challenges. Travel to domestic and/or international sites as directed by business needs.
- Continuous Improvement: Drive continuous improvement initiatives within the clinical operations function. Implement best practices and innovative approaches to enhance efficiency and effectiveness.
- Collaborative working: Work cross-functionally within Draig and with external consultants.
Qualifications and key requirements
- Advanced degree in life sciences, pharmacy, nursing, or a related field.
- Minimum of 10 years of experience in biotech or pharmaceutical industry clinical operations.
- Experience designing and implementing new procedures to ensure regulatory compliance, ideally within a small/new biotech company.
- Proven track record of successfully managing large Phase 2 multinational clinical trials (including US and European sites) from start to finish. Strong knowledge of GCP and ICH guidelines.
- Experience with submissions in the EU and US and knowledge of regulatory requirements.
- Experience in neuroscience/neuropsychiatry therapeutic area is a plus.
- Excellent leadership, communication, and interpersonal skills.
- Ability to work effectively in a fast-paced, dynamic environment.
- Strong problem-solving and decision-making abilities.
- Experience with budget management and financial oversight.
- Travel as directed by business needs.
Why Join Draig Therapeutics?
- Opportunity to make a significant impact in a new biotech company.
- Collaborative and innovative work environment.
- Competitive salary and benefits package.
- Remote working with team meetings in Cardiff.
Director Clinical Operations employer: Draig Therapeutics
Draig Therapeutics offers an exceptional opportunity for the Director of Clinical Operations to lead a dynamic team in a collaborative and innovative environment focused on addressing unmet medical needs in neuropsychiatric disorders. With a competitive salary and benefits package, along with the flexibility of remote working and team meetings in Cardiff, employees are empowered to make a significant impact while enjoying a supportive culture that fosters professional growth and development.
StudySmarter Expert Advice🤫
We think this is how you could land Director Clinical Operations
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical operations field, especially those who might have insights into Draig Therapeutics. A friendly chat can sometimes lead to opportunities that aren’t even advertised.
✨Tip Number 2
Prepare for interviews by diving deep into Draig's mission and recent developments. Show us you’re not just another candidate; demonstrate your passion for neuropsychiatric disorders and how your experience aligns with their goals.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, drop a quick thank-you note to express your appreciation. It keeps you on their radar and shows your enthusiasm for the role.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re genuinely interested in being part of the Draig team. Let’s get you that dream job!
We think you need these skills to ace Director Clinical Operations
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Director of Clinical Operations role. Highlight your relevant experience in clinical operations, especially any hands-on leadership roles you've had. We want to see how your background aligns with our mission at Draig Therapeutics!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about neuropsychiatric disorders and how your skills can help us drive our clinical programs forward. Keep it engaging and personal – we love to see your personality come through!
Showcase Your Achievements:When detailing your experience, focus on specific achievements in managing clinical trials. Use metrics where possible to demonstrate your success. We’re keen on seeing how you’ve made an impact in previous roles, especially in a fast-paced environment.
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 the role. Plus, it gives you a chance to explore more about Draig Therapeutics and what we stand for!
How to prepare for a job interview at Draig Therapeutics
✨Know Your Clinical Operations Inside Out
Make sure you brush up on your knowledge of clinical operations, especially in the context of managing outsourced models. Be ready to discuss your past experiences with clinical trials, particularly Phase 2 studies, and how you've navigated challenges in compliance and execution.
✨Showcase Your Leadership Skills
As a Director, you'll be leading a team, so it's crucial to demonstrate your leadership style. Prepare examples of how you've fostered collaboration and high performance in previous roles. Think about specific situations where you resolved conflicts or motivated your team to achieve goals.
✨Be Ready for Regulatory Discussions
Since regulatory compliance is key in this role, brush up on GCP and ICH guidelines. Be prepared to discuss how you've ensured compliance in past projects and any experience you have with submissions in the EU and US. This will show that you understand the importance of regulations in clinical trials.
✨Prepare for Stakeholder Communication Scenarios
You'll need to communicate effectively with various stakeholders, so think about how you've managed these relationships in the past. Prepare to share examples of how you've kept stakeholders informed about trial progress and how you've handled any issues that arose during the process.
