Vice President, Clinical Operations
Our client is a late-stage clinical pharmaceutical company. They have asked us to assist them in a search for a Vice President, Clinical Operations.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Identifies requirements and obtains bids for clinical research activity providers such as CROs, monitoring, data management, and other specialty vendors.
- Provides practical input to the development of clinical research protocols and other clinical trial related documents.
- Develops and negotiates clinical study budgets and participates in ongoing financial forecasting.
- Ensures quality standards for all studies are met and comply with ICH/GCP standards and regulatory authorities.
- Supports inspection and pre-inspection activities.
- Supervises clinical trial execution, including study metrics and team performance.
- Reviews outcomes and actions related to protocol deviations, supports the identification of trends across sites, and ensures accurate categorization and documentation.
- Ensures effective collaboration of cross-functional activities and clinical study teams with other functional groups.
- Functions as a lead for site audits including defining, scheduling, assessing, evaluating, and resolving outcomes on an ongoing basis.
- Proactively manages site inclusion and termination.
- Ensures study correction action and preventative action implementation, and ensures the necessary resources and tools are available.
- Conducts oversight site visits to help establish, assist, and evaluate operational execution of the study.
- Identifies risks, mitigates, resolves, and escalates operational, compliance, and other problems impacting trial progress and quality.
- Ensures effective external partnerships with study sites, investigators, and pharma trade associations.
- A Bachelor’s degree in life sciences or related scientific discipline is required, a Master’s degree is preferred.
- 10+ years of pharmaceutical or biotech industry experience in clinical research or medical affairs is required.
- Must have significant experience in planning, conducting, and managing clinical programs through Phase I-IV.
- In depth knowledge and understanding of clinical research processes, regulations, and methodology including regulatory experience supporting IND filings, pivotal trial design, and NDA filings is required.
- Requires experience with CRO management and outsourced clinical models.
- Must have demonstrated skills in the development of clinical trial protocols and study documentation.
- Requires an in-depth understanding of FDA regulations and ICH/GCP guidelines, other local guidance, regulation and codes of practices related to clinical research, and medical affairs.
- Must have strong prioritization and problem-solving skills along with the ability to juggle multiple high priority projects and to be flexible as new challenges arise.
- Strong facilitation, organization, analytical, and project management skills are required.
- Must have the demonstrated ability to drive project related activities.
- Must be comfortable working in a fast-paced and evolving company environment.
- Experience leading, managing, coaching, and developing direct reports is required.
- Requires advanced skills with MS Office and Clinical Trial Management Systems.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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