[Hiring] Director, Clinical Operations @Alfasigma

Role Description

As Director, Global Clinical Operations, you will provide both strategic and operational leadership for the execution of global clinical development programs. You will be responsible for ensuring that clinical trials are delivered on time, within budget, and in full compliance with regulatory, quality, and company requirements.

• Provide strategic oversight and operational leadership for one or more global clinical programs across Phase I-IV studies.
• Ensure clinical trials are delivered according to timelines, budgets, quality standards, and applicable regulatory requirements.
• Lead the planning, execution, monitoring, and delivery of clinical studies to achieve program and departmental objectives.
• Partner closely with Clinical Development, Medical, Regulatory Affairs, Biostatistics, Data Management, Pharmacovigilance, and other key functions to align operational execution with development goals.
• Serve as the Clinical Operations representative within Clinical Development Teams and Program Teams.
• Drive study feasibility assessments, operational planning, risk identification, and mitigation activities.
• Oversee and manage Contract Research Organizations (CROs) and vendors, ensuring performance, governance, budget control, and issue resolution.
• Lead contract oversight and CRO governance activities across complex global programs.
• Monitor study progress through key performance indicators and proactively address operational challenges.
• Ensure compliance with ICH-GCP guidelines, FDA, EMA, and other applicable global regulatory requirements.
• Provide direct line management, coaching, mentoring, performance development, and resource planning for Clinical Operations team members.
• Champion a culture of quality, accountability, collaboration, and continuous improvement across teams.
• Contribute to departmental process enhancements, inspection readiness activities, and strategic Development initiatives.
• Review and contribute to study protocols, clinical study reports, operational plans, and other critical study documentation.
• Present study and program updates to senior leadership and external stakeholders as required.
• Support organizational goals by promoting a strong "One Team" mindset focused on patients, science, and business success.

Qualifications

• Bachelor's degree in a scientific or health-related field; advanced degree preferred.
• 10+ years of experience in Clinical Operations, including at least 5 years within a pharmaceutical or biotech sponsor organization.
• Previous people management experience, with a passion for coaching and developing talent.
• Proven expertise in managing Phase I-IV clinical trials and global clinical programs.
• Strong knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements.
• Demonstrated success managing CROs, vendors, budgets, timelines, and study risks.
• Excellent leadership, project management, communication, and stakeholder management skills.
• Experience working effectively in global, cross-functional, and matrix organizations.
• Proficiency with clinical trial systems (eTMF, EDC, Veeva) and Microsoft Office applications.
• A proactive, collaborative, and solution-oriented mindset, with a strong commitment to quality and continuous improvement.
• Fluent English and willingness to travel internationally (approximately 15%).

Benefits

• Competitive salary.
• Comprehensive benefits.
• Extensive opportunities for professional growth and development.