VP of Clinical Operations

The Role of the VP of Clinical Operations

The Vice President of Clinical Operations will lead all Clinical Development Operations to achieve program objectives and ensure all successful completion of all clinical trials and related clinical trial milestones within established timelines and budgets. The Vice President will oversee the development of study protocols, clinical study execution, submissions, patient recruitment, and clinical study monitoring, clinical compliance, SOP’s, safety evaluations, preparation of statistical analysis and study data reports, data and vendor management. In addition, the Vice President will play a leadership role internally and with external stakeholders.

Qualifications:

  • Degree in health-related discipline with applied training relevant to the clinical trials or health research environment (SOCRA and its’ equivalent)

  • 15 years of relevant work experience in pharma and/or CRO

  • Master’s Degree or PhD required

  • Proven experience in contributing to the overall strategic direction of a company or business unit.

  • Experience in industry with expertise in the areas of clinical operations, development and strategic planning in early to late stage clinical trials

  • Excellent knowledge of FDA and ICH/GCP regulations and guidelines

  • Experience working in a global organization

  • Excellent organization skills and ability to multi-task in an extremely fast paced environment with changing priorities.

  • Ability and a willingness to be both strategic and tactical

  • Excellent written and verbal communication skills

  • Technical skills understanding and experience in EDC and mobile platforms (a plus)

  • PMP certification a plus

Responsibilities:

  • Responsible for strategically planning clinical trials, resourcing, and providing oversight and execution to achieve program objectives and high-quality deliverables within established timelines and budgets.

  • Lead and/or participate in the development and review of department policies, SOP’s and other controlled documents.

  • Implement processes and build a Clinical Development Operations to successfully plan and conduct multiple clinical trials in early to late stage to achieve corporate objectives.

  • Develop and implement resource management and trial metric tracking tools and establish performance goals by role. Develop and maintain systems for effectively managing service provider relationships.

  • Responsible for ensuring operational excellence in our clinical stage programs by applying high industry standards, policies, systems, and processes across all trials

  • Lead the budget negotiation process and finalize with key clinical vendors. This role will be accountable to Senior Management for ensuring studies stay within their approved clinical project budgets.

  • Lead the clinical team to ensure execution of clinical trials

  • Evaluate and monitor resources and develop resource allocation plan for all projects

  • Stay abreast of the latest developments in the fields of project management and clinical monitoring in drug development. Maintain and improve professional knowledge of technological advancements in project management and clinical monitoring.