Vice President of Clinical Operations

Vice President of Clinical Operations oversees all facets of a company’s clinical operations, providing oversight for all U.S. and international clinical trials, including managing sites, human protections and IRB oversight, patient safety, interactions with regulatory authorities as well as contributing to IND and NDAs submissions. A Vice President of Clinical Operations may be found at a pharmaceutical, medical device, biotech, clinical trial site or a Clinical Research Organization (CRO). Some companies may rely on a CRO for Phase 1 and Phase 2 studies and therefore do not have their own VP of Clinical Operations.

Contribution to Business Success

The Vice President of Clinical Operations serves as the nexus of your studies, especially phase 3 studies. The VP of Clinical Operations steers your team to avoid the potential pitfalls below and avoiding costly rework of studies. For example, FDA can and has required companies to repeat Phase 3 studies for mishaps. With an average price tag of over $200 Million for a Phase 3 studies, strong VPs of Clinical Operations pay for themselves by avoiding mishaps and insuring your studies run smoothly and on time.

Because of the nature of research, even a perfectly-designed study with no mishaps can fail to result in a marketable product. For this reason, the list of Achievements below is short while the list of Pitfalls is long.

Major Achievements (examples)

  • Successfully met all study milestones and endpoints.
  • On-time and on-budget completion of clinical trial.
  • Lead the development of the Clinical Development Plan
  • Designed clinical study (Phases I-IV) and wrote all SOPs.
  • Created and/or critically edited clinical regulatory documents including
    • protocols
    • amendments
    • clinical study reports
    • statistical analysis plans
    • investigator brochures
    • clinical sections for IND

Potential Pitfalls

  • Inability to issue clear and succinct SOPs in a timely manner.
  • Neglect to ensure SOPs are followed to the letter.
  • Failure to meet FDA deadlines.
  • Unable to anticipate FDA requirements.
  • Failure to meet regulatory requirements. (Examples include early release of data, failure to ensure patient confidentiality, failure to ensure patient safety, failure to ensure staff safety, incomplete documentation.)
  • Poor ethics.
  • Deficient budgeting or failure to avoid cost overruns.
  • Inferior choices in vendor selection.
  • Bad study design. This may include studies being put on clinical hold and FDA having a significant amount of follow up questions, which will require additional time, money and resources to answer.
  • Loss of critical staff on the clinical team. (More than half of the employees at a Phase 3 clinical-stage company may report to the VP of Clinical Operations. New study staff must be trained on the study’s SOPs incurring significant time and jeopardizing timelines.)
  • Poor people skills. This includes failure to build strong working relationships with the FDA, IRB, Chief Medical Officer, and heads of Regulatory, Quality, R&D or Biostatistics.

If your VP of Clinical Operations has hit more than one of these pitfalls it may be time for a confidential search.



MEIRxRS aims to provide three top-notch candidates in 21 business days. We vet candidates closely, interviewing them, checking with their peers and assessing each candidate for abilities to help you achieve your business objectives.

Good ClinOps candidates will not be trolling job boards looking for their next position. They will be too busy insuring their studies are running smoothly and coordinating between all the stakeholders. If there is a vacancy, your company may want to use a consultant until a replacement starts.

Confidential Searches

Your company may wish to conduct a confidential search through MEIRxRS for a number of reasons. One is to keep a faltering leader on the job until a replacement can be found. Second is that the candidate pools for such position may be small and your company may not wish for its competitors to know that you may be interviewing their employees.

Retained Searches

Retained searches are less expensive if you are committed to filling a position. A portion of the fee is paid up front, a second payment is due during the interview stage and the final payment is due after the candidate starts work. Your retained search gets first priority over contingency searches.

Contingency Searches

Companies sometimes engage multiple agencies concurrently in an effort to speed the search up. Unfortunately, this results in a barrage of agencies submitting poor-quality resumes in an effort to get their candidates in first (and earn the fee) in case they are good. Resumes may be submitted even if the candidate hasn’t been interviewed or told that their resume is being submitted to your company. Recruiters place multiple calls and emails to get the resume in first, diverting attention of hiring managers from their other responsibilities. All this undermines our goal of providing top-notch candidates for our clients. Because of this MEIRxRS will not conduct a contingency search if other agencies are working the search at the same time.

Requirements for a Vice President of Clinical Operations

Requirements usually include PhD, PharmD, or MD. Experience in a therapeutic area that the company is conducting clinical trials for is a common requirement as well. Generally, one will have held several clinical trial positions and proven their leadership, interpersonal and logical skills prior to reaching Vice President of Clinical Operations.


  • Write clear and well-understood SOPs that are easy for clinical trials staff to follow.
  • Serve as a representative to domestic and foreign regulatory bodies.
  • Contribute to the writing of INDs and NDAs
  • Manage project timelines.*
  • Manage clinical processes.*
  • Ensure staff safety and patient safety in coordination with the IRB for all stages of the investigation.
  • Manage external vendors such as Clinical Research Organizations (CROs)
  • Prepare, submit and disseminate reports internally and to regulatory bodies.
  • Represent organization at regulatory meetings.

* a project has a start and end and can be managed with a timeline while a process repeats multiple times identically.

Suggested Readings


If you would like to be confidentially contacted when we have a relevant search please contact a talent manager today.

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