Careers



Associate Director / Director, Clinical Operations

Reporting to the CEO, the Associate Director / Director, Clinical Operations would manage operational aspects of the Company’s pre-clinical and clinical development programs. This is a full-time position in the company’s San Diego headquarters. The position’s title will be determined by experience level.
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Specific responsibilities of the position include:


  • Oversees and coordinates all operational aspects of ongoing projects to ensure corporate goals of time, cost, and quality performance expectations are met.

  • Input into selection of CROs (and other vendors) and creates of contracts and/or work orders, ensures adequate oversight of vendors, identifies risks, mitigates, resolves and escalates as needed.

  • Maintaining and creating, as necessary, operational infrastructure that optimizes program efficiency, timeliness and cost

  • Optimizing, implementing and maintaining SOPs, and processes

  • Anticipating and developing strategic planning activities and ensure translation of strategic decisions into operational plans

  • Working with corporate systems to choose, integrate and maintain systems, as necessary

  • Representing pre-clinical and clinical plans and status, both internally and externally

  • In conjunction with project team, helping to direct and assure consistency with regard to all aspects of timeline/fiscal management, analyses, compliance, and conducting global and domestic clinical trials to ensure delivery of company goals on time, within budget and in compliance with Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) and International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines

  • Partnering collaboratively with key internal / external functions such as Medical, Regulatory, CMC, and Program Management to implement the Company’s pre-clinical and clinical operations and drive organizational success

  • Performing related duties as assigned

  • Maintaining compliance with all company policies and procedures

Requirements:


  • 4 year life sciences or health care related degree

  • Minimum 3 years of project management and/or clinical operations management experience

  • Experience with oversight of direct reports

  • Proficient in MS Office software

  • Excellent verbal and written communication skills



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