Clinical Trial Director - EPM Scientific - Phaidon International

Job Title: Clinical Trial Director

Location: Boston, Massachusetts

Salary: $180,000-$220,000

Job Summary: The Clinical Trial Director will lead and oversee all clinical trial activities for their lead asset focused in radiopharmaceuticals. This role is critical in ensuring the successful execution of clinical trials, from early-phase studies through to late-stage development. It is also critical in the company's expansion into the US and overseeing their new US sites. The director will report to the Head of Development.

Key Responsibilities:

• Develop and implement clinical operations strategies to support the company's oncology radiopharmaceutical pipeline.
• Provide leadership and direction to the clinical operations team, ensuring alignment with corporate goals and objectives.
• Oversee the planning, execution, and management of clinical trials, ensuring they are conducted in compliance with regulatory requirements and Good Clinical Practice (GCP).
• Manage all aspects of clinical trials, including site selection, patient recruitment, data collection, and monitoring.
• Ensure timely and accurate reporting of trial progress and results to senior management and stakeholders.
• Develop and manage clinical trial budgets, timelines, and resources.
• Ensure all clinical trial activities are conducted in accordance with regulatory requirements and company SOPs.
• Prepare and submit regulatory documents to ethics committees and regulatory authorities.
• Lead, mentor, and develop the clinical operations team, fostering a collaborative and high-performance culture.
• Provide training and support to team members to ensure continuous professional development.
• Collaborate with cross-functional teams, including clinical research, regulatory affairs, data management, and biostatistics, to ensure the successful execution of clinical trials.
• Act as a key liaison between the clinical operations team and other departments within the company.

Qualifications:

• Minimum of 10 years of experience in clinical trial management, with at least 5 years in a leadership role.
• Minimum 7 years of experience in biotech on the sponsor side.
• Excellent organizational, communication, and leadership skills.
• Proven ability to manage multiple projects and priorities simultaneously.

Preferred Qualifications:

• Experience in early-phase oncology trials.
• Radiopharmaceutical experience.