Clinician
A Subject Matter Expert in medical and drug safety with clinical development experience in vaccines and therapeutics is needed to provide contracted support to the Biomedical Advanced Research and Development Authority (BARDA), within the US Department of Health and Human Services in Washington, DC.
The mission of BARDA is to develop and procure medical countermeasures (MCM) that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases.
Specifically, BARDA supports the advanced development and procurement of drugs, vaccines and other products that are considered priorities for national health security.
For more information on BARDA please visit their website at:
Major Duties &
Responsibilities:
Provide medical and product safety clinical development subject matter expertise for advanced development of therapeutics, vaccines, diagnostics, and devices related to COVID-19.
Special emphasis of this position will be on COVID-19 clinical research and medical management aspects of interventional clinical trial design and execution leading to regulatory approval for advanced products, and on bringing this perspective to project teams at all developmental stages.
Review contract proposal and related documents.
Assist in contract negotiations on technical matters.
Deliverables:
Deliverables would include work products related to the development and management of clinical studies and programs within current and planned COVID-19 vaccine, therapeutic, diagnostics, and devices advanced development and acquisition contracts.
Requirements:
Application of Doctoral Degree in Medicine and US Board Certification or equivalent with relevant experience in clinical development Established reputation as a subject matter expert as evidenced by peer reviewed publications, leadership positions and membership in professional associations.
Expert in development of medical countermeasure products, anti-virals, anti-infectives, monoclonal antibodies for infectious diseases.
Vaccines, with particular expertise in clinical development from pre-IND through advanced development, NDA/BLA submissions, and post-licensure phases of activity.
Please be advised that Tunnell employees are required to be fully vaccinated against COVID-19 as per CDC guidelines and subject to legal requirements.
In accordance with Tunnell's COVID-19 Vaccination Policy, employees need to confirm that they are fully vaccinated or engage in an interactive dialogue with Human Resources to determine eligibility for a religious or medical exception, and whether making such an exception would pose an undue burden or undue risk of harm.
Additionally, client-facing employees are also expected to comply with all current and future client requirements for COVID-19 safety, including but not limited to surveillance testing, masking requirements, social distancing, and any other requirements.
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Estimated Salary: $20 to $28 per hour based on qualifications.
The mission of BARDA is to develop and procure medical countermeasures (MCM) that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases.
Specifically, BARDA supports the advanced development and procurement of drugs, vaccines and other products that are considered priorities for national health security.
For more information on BARDA please visit their website at:
Major Duties &
Responsibilities:
Provide medical and product safety clinical development subject matter expertise for advanced development of therapeutics, vaccines, diagnostics, and devices related to COVID-19.
Special emphasis of this position will be on COVID-19 clinical research and medical management aspects of interventional clinical trial design and execution leading to regulatory approval for advanced products, and on bringing this perspective to project teams at all developmental stages.
Review contract proposal and related documents.
Assist in contract negotiations on technical matters.
Deliverables:
Deliverables would include work products related to the development and management of clinical studies and programs within current and planned COVID-19 vaccine, therapeutic, diagnostics, and devices advanced development and acquisition contracts.
Requirements:
Application of Doctoral Degree in Medicine and US Board Certification or equivalent with relevant experience in clinical development Established reputation as a subject matter expert as evidenced by peer reviewed publications, leadership positions and membership in professional associations.
Expert in development of medical countermeasure products, anti-virals, anti-infectives, monoclonal antibodies for infectious diseases.
Vaccines, with particular expertise in clinical development from pre-IND through advanced development, NDA/BLA submissions, and post-licensure phases of activity.
Please be advised that Tunnell employees are required to be fully vaccinated against COVID-19 as per CDC guidelines and subject to legal requirements.
In accordance with Tunnell's COVID-19 Vaccination Policy, employees need to confirm that they are fully vaccinated or engage in an interactive dialogue with Human Resources to determine eligibility for a religious or medical exception, and whether making such an exception would pose an undue burden or undue risk of harm.
Additionally, client-facing employees are also expected to comply with all current and future client requirements for COVID-19 safety, including but not limited to surveillance testing, masking requirements, social distancing, and any other requirements.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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