Director of Clinical Operations
Responsible for overseeing the conduct of the company's clinical studies. Sets strategic and functional plans for managing clinical operations activities for product approval. The position interacts with various groups within the company and external to the business in the execution of clinical operations activities. This role requires strategic thinking, solution-finding, and agility as evidenced by flexibility, adaptability to change, curiosity, and ability to lead and drive change.
Essential Duties and Responsibilities:
- Oversees and supervises clinical operations staff and contract staff/contract research organizations (CROs) and ensures that these activities are conducted in accordance with applicable regulatory requirements and guidelines including the company's standard operating procedures, ICH-GCP guidelines, regulatory authority regulations, and patient safety standards, as applicable.
- Creates, executes, and proactively manages clinical study processes.
- Ensures successful and timely recruitment of appropriate clinical study participants in line with corporate goals.
- Ensures the identification, recruitment, and selection of appropriate clinical investigators and CROs as well as the appropriate negotiation of contracts.
- Provides leadership, strategic oversight, and guidance of clinical operations to ensure quality, timeline, resources, and budget goals are met.
- Leads and mentors clinical operations staff to support successful internal training and its implementation and serve as an advocate for professional development of clinical operations staff.
- Develops clinical study protocols, investigator brochures and CRFs, study monitoring plans, and data management plans and execution.
- Establishes performance indicators to ensure the successful execution of clinical studies in line with corporate timelines.
- Conducts assessment and disposition of study adverse events in conjunction with Medical Affairs during ongoing clinical studies.
- Oversee, plan and implement all activities required for the generation of high-quality data deliverables on time and on budget (e.g., development of case report forms, collaboration with statisticians, collaboration with data managers, data overview, clinical study reports, etc.).
- Analyzes, interprets and presents results of clinical studies to internal and external stakeholders.
- Provide periodic status updates and effectively communicates with the Management Team, Project Teams, Board of Directors, and other key internal stakeholders. Ensures cross-functional alignment for clinical operations across medical affairs, regulatory, product development, and commercial.
- Develop and maintain strong relationships with CROs, external experts, and Investigators to ensure effective execution of internal and external clinical projects.
- Provide support for regulatory submissions, supporting dossier development, and participating in interactions with applicable worldwide regulatory agencies.
- Remains up-to-date with current information on clinical study regulations, guidelines, and practices to ensure consistent best practices across all activities.
- Ability to travel extensively to clinical sites in North America.
- Bachelor's degree in a scientific discipline, preferably life sciences, biomedical or other related discipline; advanced degree (MS or Ph.D., or MD) a plus.
- 15+ years of experience leading clinical development activities in the biotech industry. Extensive previous managerial experiences in conducting IVD clinical studies required.
- Extensive knowledge of medical device and IVD clinical development and should include prior experience with clinical development planning, regulatory requirements and documents, study design, biostatistics, monitoring, data handling, data analysis, report writing and scientific presentation of data.
If interested in learning more, please contact Bria Gaber at email@example.com or (646) 430-1191 for more information.