Position Overview:

The Head of Clinical Operations is responsible for overseeing and managing all aspects of clinical trial operations. This role includes strategic planning, execution, and management of clinical studies across various phases (I-III) to ensure regulatory compliance, efficiency, and achievement of company objectives. The role involves leadership in process development, team management, budget oversight, and collaboration with cross-functional teams including regulatory, medical affairs, and commercial departments.

Reporting directly into the CMO, you are involved in key strategic decsions, have automony in your role but with the support of a world class leadership team.

Key Responsibilities:

1. Leadership & Strategy:

• Provide strategic leadership to the clinical operations team, ensuring alignment with corporate goals and clinical development plans.
• Develop and execute operational strategies for clinical trial management, ensuring optimal delivery of clinical programs on time and within budget.
• Lead efforts to streamline clinical processes, improve operational efficiencies, and foster innovation within the clinical operations team.

1. Clinical Trial Oversight:

• Oversee the planning, initiation, and execution of global clinical trials, including vendor selection and management, site selection, monitoring, data collection, and analysis.
• Ensure all clinical operations are conducted according to Good Clinical Practice (GCP), regulatory requirements (FDA, EMA, etc.), and company SOPs.
• Provide oversight on patient recruitment strategies to meet enrollment goals within expected timelines.

1. Team Management:

• Lead, mentor, and develop a high-performing clinical operations team, including clinical trial managers, clinical research associates, and other relevant staff.
• Foster a culture of collaboration, continuous learning, and professional development within the clinical operations group.
• Manage resources, including staffing and training, to support clinical programs.

1. Vendor & Stakeholder Management:

• Manage relationships with Contract Research Organizations (CROs), clinical sites, and other external vendors involved in the conduct of clinical trials.
• Negotiate and manage contracts, budgets, and timelines with external partners to ensure successful delivery of clinical studies.
• Collaborate with internal cross-functional teams including regulatory, biostatistics, and medical writing to ensure seamless integration of clinical operations.

1. Regulatory Compliance & Risk Management:

• Ensure compliance with global regulatory requirements and ethical standards for the conduct of clinical research.
• Monitor and mitigate risks related to clinical trial execution, including patient safety, data integrity, and timeline deviations.
• Prepare and review clinical operations sections of regulatory submissions (IND, NDA, BLA, etc.) and audits/inspections.

1. Budget & Financial Oversight:

• Oversee clinical trial budgets, ensuring cost-effective resource allocation and adherence to financial constraints.
• Track and report on clinical operations performance, including budget variances, trial timelines, and key performance indicators (KPIs).
• Ensure accurate and timely financial forecasting for clinical trials, and report progress to senior management.

1. Innovation & Process Improvement:

• Implement best practices, tools, and technology solutions to enhance clinical trial management and operational efficiency.
• Drive continuous improvement initiatives to optimize clinical trial processes and patient engagement strategies.
• Stay updated on industry trends, regulatory changes, and advancements in clinical trial operations to ensure cutting-edge practices.

Qualifications:

• Advanced degree in Life Sciences (MD, PhD, PharmD, or equivalent) or a related field preferred.
• Minimum of 12 years of experience in clinical operations, with at least 5 years in a leadership role.
• Proven track record in Oncology.
• Proven track record of managing global clinical trials across multiple phases (I-III).
• Strong understanding of GCP, ICH guidelines, and regulatory requirements.
• Experience working with CROs, vendors, and cross-functional teams.
• Excellent leadership, communication, and organizational skills.
• Ability to manage multiple complex clinical programs simultaneously.
• Strong financial acumen and experience in budget management.

Preferred Skills:

• Proficiency in clinical trial management systems (CTMS) and other relevant software.
• Experience in regulatory submissions and clinical development in a biotech or pharmaceutical environment.