Position Overview
The Director of Clinical Operations will lead the strategic planning, execution, and oversight of clinical research programs, ensuring compliance with regulatory standards and advancing oncology clinical trials. This role requires a deep understanding of clinical research, regulatory submissions, and technical documentation to support high-quality study outcomes.
Key Responsibilities
* Oversee the management and execution of oncology clinical trials from initiation to completion, ensuring adherence to timelines, budgets, and regulatory guidelines.
* Lead and mentor cross-functional teams, including clinical research associates, project managers, and regulatory specialists.
* Develop and implement operational strategies to optimize clinical trial efficiency and effectiveness.
* Manage regulatory submissions, including Investigational New Drug (IND) applications, Clinical Trial Applications (CTA), and other required documentation.
* Ensure compliance with GCP, FDA, EMA, and other relevant regulatory requirements.
* Collaborate with investigators, sponsors, and external partners to ensure seamless trial execution and alignment with research objectives.
* Oversee technical document writing and editing, ensuring clarity, accuracy, and compliance with industry standards.
* Monitor and evaluate trial performance, implementing improvements to enhance operational efficiency and study integrity.
* Stay up to date with industry trends, emerging technologies, and regulatory changes impacting clinical research.
Qualifications & Experience
* Bachelor’s or Master’s degree in life sciences, clinical research, or a related field.
* Minimum of 10 years of experience in clinical research, with a strong focus on oncology trials.
* Proven expertise in regulatory submissions, including INDs, CTAs, BLAs, MMAs.
* Strong technical writing and editing skills, with experience in developing regulatory and clinical documents.
* In-depth knowledge of GCP, FDA, EMA, and other regulatory frameworks.
* Leadership experience with the ability to mentor and develop teams.
* Excellent problem-solving and decision-making skills with a proactive and strategic mindset.
* Strong communication and collaboration skills to work effectively with internal and external stakeholders.