• Full Time (Salaried)
  • Remote,

Company:  Confidential

Job Title: VP of Clinical Operations

Job Number: 34630

Location: Remote, 

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.

 

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