Job Title: Head of Clinical Operations
Location: Cambridge, Massachusetts
Salary: $250,000-$290,000
Job Summary: The Head of Clinical Operations will lead and oversee all clinical operations activities, ensuring the successful execution of clinical trials for radiopharmaceutical related trials. This role requires a strategic leader with extensive experience in clinical operations, project management, and regulatory compliance. The successful candidate will work closely with cross-functional teams to drive clinical development programs from initiation to completion.
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 15 years of experience in clinical trial management, with at least 8 years in a leadership role.
- Minimum 5 years of experience in radiopharmaceuticals, 10 years in early phase oncology.
- Excellent organizational, communication, and leadership skills.
- Proven ability to manage multiple projects and priorities simultaneously.
