Clinical Operations Director (UK)
New Yesterday
The Role: We are seeking a
Clinical Operations Director
with deep expertise in Phase 1 and Phase 2 trials execution and CNS drug development. Experience in sleep-focused clinical studies would be advantageous. This role will provide strategic leadership and operational oversight for clinical trials across the UK, Europe, and potentially Australia and US. You will manage both a virtual team and CRO partners to ensure high-quality, timely, and cost-effective trial delivery. This role is ideal for a seasoned clinical operations professional who thrives in small teams, embraces a can-do attitude, and enjoys taking ownership of projects from strategy through execution.
Key Responsibilities
Strategic & Operational Leadership Reporting to the Chief Medical Officer you will provide hands-on leadership and strategic oversight of all clinical operations activities across assigned regions. Develop and implement operational strategies aligned with AstronauTx’s early-stage CNS/sleep clinical development programs. Ensure studies are conducted in compliance with ICH-GCP, GxP, local regulations, and internal SOPs. Act as senior operational escalation point for study risks, issues, and quality concerns.
CRO & Vendor Oversight Lead selection and management of CROs and vendors, ensuring alignment with company goals and budget. Drive proactive risk management, including mitigation planning and corrective actions. Monitor CRO performance across all study phases, ensuring KPIs for timelines, quality, budget, and site performance are met.
Portfolio & Study Management Maintain accountability for successful study delivery, milestone achievement, and recruitment targets. Oversee clinical trial budgets, forecasting, and reconciliation. Ensure inspection readiness and appropriate documentation in the CTMF/eTMF. Provide executive-level reporting on study metrics and operational performance.
Regulatory & Compliance Oversight Ensure compliance with regional regulatory frameworks (UK MHRA, EMA, TGA, FDA) in collaboration with Regulatory Affairs. Maintain oversight of regulatory submissions, inspections, and reporting obligations. Champion a quality-focused culture and continuous improvement in all clinical operations activities.
Cross-Functional Leadership Collaborate closely with Regulatory, Pharmacovigilance, Data Management, Biostatistics, and Supply Chain teams. Partner with site engagement teams to optimize investigator networks and site selection. Oversee IMP supply strategy to ensure uninterrupted trial conduct.
Team Development & Culture Lead, mentor, and inspire a (virtual) Clinical Operations team, fostering a hands-on, collaborative, and can-do culture with a view to growing internal team as the company expands it’s portfolio of clinical stage programs. Drive adoption of best practices, innovation, and operational excellence in a matrixed cross functional-team environment.
Qualifications & Experience
Education Bachelor’s degree in Pharmacology, Biotechnology, Life Sciences, or related scientific discipline.
Experience 10+ years in clinical operations, ideally within biotech. Proven experience managing Phase 1 and Phase 2 trials, particularly CNS and sleep-focused programs. Strong track record of leading cross functional teams and CRO partnerships. Familiarity with UK, EU, and global regulatory requirements and competence in the application of standard business procedures (SOPs, ICH, Ethics and Compliance). Budget accountability and financial oversight experience at portfolio level. Experience supporting regulatory inspections and audits.
Competencies & Mindset Strategic thinker with strong execution skills. High level of autonomy, accountability, and decision-making authority. Hands-on, can-do attitude with a willingness to roll up sleeves. Comfortable thriving in small, semi-virtual, fast-paced teams. Strong leadership, communication, and stakeholder management skills. Understanding of quality systems and inspection readiness.
Reporting Line Reports to: Chief Medical Officer
- Location:
- United Kingdom
- Job Type:
- FullTime
- Category:
- Biotechnology Research