Reports to: Vice President of Clinical Development
Job Summary: The Director of Clinical Operations will lead and oversee all clinical trial activities for oncology programs. This role is critical in ensuring the successful execution of clinical trials, from early-phase studies through to late-stage development. The Director will work closely with cross-functional teams, including clinical research, regulatory affairs, and data management, to drive the development of innovative cancer therapies.
Key Responsibilities:
Leadership and Strategy:
Develop and implement clinical operations strategies to support the company's oncology 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).
Trial Management:
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.
Vendor and CRO Management:
Select and manage Contract Research Organizations (CROs) and other vendors.
Monitor vendor performance to ensure quality and compliance with contractual obligations.
Regulatory Compliance:
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.
Team Leadership and Development:
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.
Cross-Functional Collaboration:
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:
Advanced degree in life sciences, nursing, or a related field (PhD, MD, or equivalent preferred).
Minimum of 10 years of experience in clinical trial management, with at least 5 years in a leadership role.
Minimum 10 years of oncology therapeutic area and clinical development processes.
Excellent organizational, communication, and leadership skills.
Proven ability to manage multiple projects and priorities simultaneously.
Preferred Qualifications:
Experience in early-phase oncology trials.
Experience with in-house model.
Benefits:
Competitive benefits package (401k match, medical health care 100% covered, PTO).