RHO

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Vice President, Clinical Operations

Vice President, Clinical Operations

ID 
2017-1363
Job Location 
US-NC-Chapel Hill
Type 
Regular Full-Time

More information about this job

Overview

Reporting to the CEO, the Vice President, Clinical Operations will provide strategic oversight for all clinical operations activities at Rho.

Responsibilities

  • Serving as a point of escalation for clinical operations and clinical project team issues.
  • Mentoring, developing, and training clinical personnel and teams.
  • Providing leadership in the area of clinical operations, including supporting the development of sound enrollment/subject recruitment plans and site feasibility approaches, assisting with clinical research associate challenges, and facilitating the resolution of investigator site issues.
  • Collaborating effectively across clinical research disciplines including statistics, data management, interactive response systems, investigational product management, regulatory, medical writing, etc.
  • Growing Rho’s full-service business through networking, leading proposal strategies, acting as the senior clinical expert in bid defenses, participating in business development activities, and creating clinical content for marketing purposes.
  • Acting as a visible industry expert in clinical operations, ensuring that industry trends in clinical operations are disseminated in a way that supports incorporation of relevant practices into Rho’s operations.

Qualifications

  • BS required and minimum of 15 years of bio/pharmaceutical development experience in clinical trial operations; CRO experience strongly preferred
  • Broad experience in drug/biologics development with expertise in clinical trial conduct from Phase 1 through Phase 3 including IND and NDA/BLA/MAA submissions
  • Experience in strategic planning of clinical trials
  • Demonstrated leadership capabilities, effective organizational skills, and excellent verbal and written communication
  • Expertise in building infrastructure to support clinical research, including recommending policies and procedures, best practices, and impactful process and systems improvements for a growing organization
  • Demonstrated interest in and ability to mentor and develop personnel
  • Excellent working knowledge of FDA, EMA & ICH/GCP regulations and guidelines
  • Ability to work in a team environment, meet deadlines, and prioritize and balance workloads
  • Ability to motivate individuals and teams
  • Ability to recognize, anticipate, and analyze complex problems and create successful solutions
  • Willingness and ability to travel as required