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Director of Clinical Operations

Company: Morphogenesis, Inc.
Location: Zephyrhills
Posted on: January 15, 2022

Job Description:

DIRECTOR OF CLINICAL OPERATIONS

LOCATION

Tampa, Florida

COMPANY

Morphogenesis, Inc. is a biomedical company focused on the isolation, growth, and maintenance of hematopoietic stem cells.

JOB SUMMARY

The primary role of the Director of Clinical Operations is to provide clinical and medical expertise to advance the Morphogenesis oncology pipeline. S/he is a key member of the senior staff and contributes to the clinical strategy and execution of clinical programs. The Director of Clinical Operations partners with the Vice President of Product Development and Product Management along with the Senior Medical Director and Regulatory Affairs associates to provide medical monitoring, strategic input, and overall clinical trial leadership and support, while collaborating with external partners including contract research organizations (CROs), principal investigators, clinical site personnel, key opinion leaders and funding agencies. Success in this role requires self-motivation, creativity, integrative thinking, and a strong work ethic. The candidate is expected to thrive in a dynamic, changing environment of biotechnology.

RESPONSIBILITIES

  • Provide leadership for medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site, and patient level.
  • Lead development of and adherence to safety review. Perform and document regular review of individual subject safety data and cumulative safety data.
  • Monitor study safety issues and provide input to serious adverse events (SAEs) reports.
  • Communicate safety information to sites across the study and provide responses to questions on safety. Provide medical leadership during the creation of the clinical development plan.
  • Design clinical studies to meet the stated objectives. Ensure clinical trial objectives fit with the clinical program strategy.
  • Review and ensure that documents (protocol, Informed Consent Document [ICD], etc.) meet regulatory requirements and company policy and has been reviewed by IRB/IECs.
  • Provide medical input into site and feasibility
  • Provide medical monitoring of clinical trials, with focus on subject eligibility, safety assessments, and data integrity.
  • Provide clinical input to protocol / study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, and data quality planning as needed.
  • Develop and maintain peer-to-peer relationships with healthcare professionals at clinical trial sites.
  • Advise and contribute to contract research organization / vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines, including ensuring medical/technical requirements for data integrity are applied.
  • Work with study team to ensure high quality of data, e.g. appropriate patient population, adequacy of clinical assessments as study is ongoing.
  • Conduct medical review and interpretation of efficacy and safety data from clinical trials, including delivery of top-line report in collaboration with study statistician and delivery of clinical study report in collaboration with medical writer; accountable for overall quality and timeliness of analysis and reporting.
  • Responsible for medical and scientific validity of study report, especially conclusions regarding efficacy and safety. Responsible for disclosure of appropriate safety and efficacy data and conclusions (e.g. ClinicalTrials.gov, EudraCT.).
  • Provide protocol specific training to study team, investigators, clinical research associate, and others.
  • Interact with healthcare professionals at sites during the conduct of the study to enable quality, compliance and patient safety at the trial, site and patient level.
  • Participate with Data Monitoring Committees and Steering Committees as required.
  • Monitor investigator compliance with protocol and regulatory requirements.
  • Support study team in issues resolution, study closeout, audit responses, and inspection readiness.
    QUALIFICATIONS
    • 10+ years clinical trial operations experience
    • Experience in pre-cancer and/or oncology, vaccines, pharmacovigilance, and clinical development preferred.

Keywords: Morphogenesis, Inc., Brandon , Director of Clinical Operations, Executive , Zephyrhills, Florida

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