Director Clinical Operations in London

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.

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.

• 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.

• 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.

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.