Company:  Confidential

Job Title: VP of Clinical Operations

Job Number: 76494

Location: Remote, US

Job Description

As a VP Clinical Operations you will lead the clinical programs while supporting quality and compliance, strong focus on strategy and operations. Reporting to the CEO Experience executing pre-clinical and clinical programs for medical devices, biologics, or combination products ideal  

Responsibilities

* Design and implement strategic plans for clinical programs, to ensure alignment with company objectives and regulatory requirements. * Partner closely with the Regulatory team on study design elements, such as protocols and study plans with FDA. * Oversee the design, execution, and monitoring of clinical trials * Work with KOLs on protocol designs including endpoints and strategy. * Manage pre-clinical efforts in conjunction with the Regulatory organization. * Engage Ethics Committees and Institutional Review boards for expedient approvals. * Highly involved with data management – planning, partnering with CROs, SAPs, and prepare study reports to FDA * Work closely with statisticians, involved in statistical analyses, as needed, to assess if trials are achieving objectives. Assess if correct statistical methods are used in both pre-clinical and clinical efforts. * Oversee and manage CROs, including establishing and managing budgets  * Partner with Quality and Regulatory leads to support the establishment and implementation of a robust quality management system (QMS)  * Conduct audits of clinical sites for FDA inspection readiness. * Collaborate closely with R&D and Manufacturing teams to integrate clinical, quality, and regulatory considerations into all aspects of product development. * Stay abreast of changes in clinical, quality, and regulatory requirements and proactively advise the organization on potential impacts.

Required Skills

* Experience in designing and executing medical device and/or combination product clinical trials, quality assurance, and regulatory affairs within the biotech or pharmaceutical industry. * Strong leadership experience overseeing clinical operations teams, while managing all aspects of clinical trial design and implementation including CRO oversight for multiple successful clinical studies. * Advanced degree in a relevant scientific discipline (MD, PhD, or equivalent) preferred. Equivalent professional experience will be considered in lieu of formal education. * Solid understanding of both device and drug regulations, combination products a plus! * Proven track record of successful leadership in managing and directing cross-functional teams. * Extensive experience and in-depth knowledge of global regulatory requirements, with a proven track record of successful interactions with regulatory agencies on a global scale. * Experience working with quality control, statistics, and biostatistics required. * Understanding of the processes of pooling data across sites, demographics, and study Phases. * ~15 years of experience across various medical disciplines falling within orthopedic indications * Excellent communication and interpersonal skills, with the ability to influence and negotiate effectively.

Application Deadline: 2024-05-13

 

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