Senior Director of Clinical Operations

Posted 18 days 11 hours ago by Neurana Pharmaceuticals, Inc.

Permanent
Not Specified
Academic Jobs
California, San Diego, United States, 92101
Job Description

POSITION SUMMARY:

Neurana Pharmaceuticals is expanding its Clinical Operations department in order to support the development of tolperisone to treat acute, painful muscle spasms. Working directly with the company's Chief Medical Officer, the Sr Director of Clinical Operations will manage the Phase 1 and pre-clinical program operations to ensure the effective and efficient execution of all operational aspects of clinical study planning, implementation, data delivery and reporting. You will ensure that a robust communication plan, including status and timing of operational deliverables, is in place for all studies and programs.

ESSENTIAL FUNCTIONS:

  • Develop operational strategies for implementation of Phase 1 studies in conjunction with project teams and other cross functional departments
  • Ensure consistent and successful execution of all operational aspects of studies as appropriate, including resourcing, timelines, budget, data delivery and reporting
  • Work with finance department to ensure vendor governance structure, incorporate performance metrics, and contribute to outsourcing discussions
  • As a member of the Clinical Operations leadership team, provide leadership to Clinical Operations staff and to project teams for vendor evaluation, selection, management and quality-based oversight
  • Work in collaboration with Quality Management and Quality Assurance to develop and implement quality activities within Clinical Operations
  • Support the Chief Medical Officer in establishing and maintaining an organizational structure and staffing to effectively accomplish the clinical goals and objectives.
  • Take responsibility for the ongoing leadership support within the Clinical Operations group including recruitment, training, mentoring, career development, work assignments and performance evaluations.
  • Effectively oversee, manage, and influence CROs to ensure successful execution of the studies, and build strong relationships to create strong alliances
  • Effectively negotiate and influence to solve high impact/scope problems and expose organizational problems
  • Understand, identify, mitigate, and communicate risks at the operational level
  • Develop and execute strategies to improve processes and set direction in study management and related areas such as compliance, CRO management and risk management

EXPERIENCE / QUALIFICATIONS:

  • Qualified candidates must have a bachelor's degree from an accredited college or university
  • 10 years relevant experience is required with an advanced degree strongly preferred (PhD)
  • Experience considered relevant includes clinical or basic research in a pharmaceutical company, a medical device / diagnostic company, academic research organization (ARO) or contract research organization (CRO). Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant
  • Demonstrates advanced knowledge of design, development and implementation of Phase 1 studies
  • A minimum of 3 years Phase 1 experience required.
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