Director of Clinical Operations
Company: Morphogenesis, Inc.
Posted on: January 15, 2022
DIRECTOR OF CLINICAL OPERATIONS
Morphogenesis, Inc. is a biomedical company focused on the
isolation, growth, and maintenance of hematopoietic stem cells.
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.
- 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
- Design clinical studies to meet the stated objectives. Ensure
clinical trial objectives fit with the clinical program
- 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
- 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
- Support study team in issues resolution, study closeout, audit
responses, and inspection readiness.
- 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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