Executive Director Clinical Operations - Permanent - Cambridge MA
Are you ready to make a groundbreaking impact in the world of biotechnology? Join a growing company that's shaping the future of healthcare and science.
娇色导航 is seeking an Executive Director of Clinical Operations to deliver strategic leadership and operational oversight for clinical trial activities within an early-phase drug development setting.
Primary Responsibilities:
In this role, you will lead the Clinical Operations team, ensuring trials are conducted efficiently, effectively, and in compliance with regulatory standards. This position requires a strong focus on cross-functional collaboration, vendor management, and maintaining inspection readiness.
Skills & Requirements:
- Bachelor's degree required; advanced degree in Biomedical or Life Sciences preferred.
- Background in oncology is strongly preferred.
- Expertise in clinical operations across all stages of the clinical trial lifecycle, including regulatory inspection readiness.
- Experience in high-growth, dynamic environments with global, matrixed team management.
- Proficiency in creating and maintaining SOPs, quality documents, and compliant operational environments.
- Familiarity with regulatory document development (e.g., protocols, IBs, CSRs, INDs).
- Experience supporting BLA/NDA submissions and working across early- and late-phase global programs.
- Strong understanding of GCP, ICH guidelines, and clinical documentation standards.
- Proficiency in clinical systems such as Veeva Vault eTMF, RAVE, and SharePoint.
- Excellent organizational skills, attention to detail, and ability to manage multiple priorities.
- Strong verbal and written communication skills.
- Willingness and ability to travel internationally for clinical site engagement and oversight.
The Executive Director, Clin Ops' responsibilities will be:
- Provide strategic leadership and guidance for the clinical operations function to meet corporate goals, timelines, and quality standards.
- Oversee all aspects of clinical trial execution, including study planning, data cleaning, database lock, and regulatory inspection preparedness.
- Integrate clinical operations expertise into clinical development activities, such as protocol design, quality plans, and clinical supply logistics.
- Develop and monitor key performance indicators to ensure successful trial execution.
- Foster cross-functional communication and collaboration to support organizational priorities.
- Represent clinical operations in internal and external stakeholder meetings, providing updates and insights.
- Manage and mentor the Clinical Operations team, supporting professional growth and team success.
- Guide vendor selection, management, and oversight, including the development of vendor oversight plans.
- Identify and mitigate risks associated with clinical trial execution.
- Drive process improvement initiatives to enhance operational efficiency.
Compensation:
- $285,000 to $310,000 per annum.
If you are having difficulty in applying or if you have any questions, please contact Ciara Noble at c.noble@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
娇色导航 is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. 娇色导航 is acting as an Employment Agency in relation to this vacancy.
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