SciPro are partnered with a leading, privately held biopharmaceutical company and leading their search for a Director of Clinical Operations based in the UK to oversee and drive global clinical trial activities for a late-stage development program in rare diseases. This pivotal leadership role focuses on managing complex outsourced trials, ensuring timelines, quality, and regulatory compliance in a fast-paced environment.
The company is committed to advancing a best-in-class monoclonal antibody therapy to address unmet clinical needs in rare macrophage-driven diseases. By combining deep scientific expertise with patient-centred innovation, the organization strives to significantly improve patient outcomes and quality of life.
Key Responsibilities
- Clinical Trial Oversight: Lead end-to-end global trial planning and execution, managing multiple CROs and vendors, and ensuring delivery on time and within budget.
- Stakeholder & Team Leadership: Act as a key liaison between cross-functional teams and senior leadership, while mentoring team members and guiding resource allocation.
- Compliance & Risk Management: Ensure adherence to GCP, ICH, and regulatory guidelines, maintain trial documentation readiness, and proactively manage operational risks.
Key Requirements
- Experience: Proven track record in clinical project management, ideally within biotech or fast-paced start-up environments; extensive knowledge of trial regulations and processes.
- Skills: Strong leadership, communication, and analytical skills; adept with tools like CTMS, eTMF, EDC (preferably Medidata RAVE), and Microsoft Project.
- Mindset: Highly organized, proactive, and flexible with a hands-on approach; comfortable working autonomously and contributing across functional areas when needed.
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