The National Institute of Allergy and Infectious Diseases (NIAID) has mobilized its major research networks under the collaboration of the COVID-19 Prevention Network (CoVPN) to work together in the rapid evaluation of COVID-19 treatment and prevention strategies. This approach leverages the well-established infrastructure, expertise, and on-going partnership of these networks with the resources of the National Institutes of Health (NIH) and developers of vaccines, monoclonal antibodies, drugs, and other potential interventions for COVID-19 treatment and prevention.
The Leadership and Operations Center (LOC) of the NIAID-funded HIV Prevention Trials Network (HPTN), housed at FHI 360, will oversee the development of monoclonal antibodies (mAb) for COVID-19 prevention within the CoVPN. Responsibilities of the CoVPN LOC at FHI 360 include:
- Protocol Development and Coordination
- Protocol Specific Training of Clinical Research Sites
- Oversight of Clinical Research Sites prior to and during study conduct
- Dissemination of study results
- Communication, Community Education, and Information Dissemination
The COVID-19 Prevention Network (CoVPN) seeks a physician who will consult on clinical matters for CoVPN. This position is at least 50% effort (20 or more hours per week). Responsibilities include:
- Provide scientific review and input into concept and protocol development.
- Collaborate with protocol team leadership to develop systematic methods of providing guidance to clinical research site teams on clinical management, ensuring consistency and harmonization across studies.
- Be knowledgeable of all assigned study protocols, including study drug profiles.
- Represent the Network in interactions with investigators and pharmaceutical manufacturers as needed
- Manage queries to the clinical management committees (CMCs) for CoVPN mAb studies, per the requirements of the protocol, and ensure all queries from sites to the CMC are resolved
- Review and identify trends and signals in study-specific clinical and laboratory events.
- Collaborate with protocol team leadership to create and revise regulatory documents that pertain to clinical management issue such as Serious Adverse Events (SAE) reporting.
- Collaborate with team leadership and statistical center on Study Monitoring Committee/Data and Safety Monitoring Board review activities as they pertain to relevant clinical issues.
- Collaborate with protocol team leadership to conduct site trainings and re-trainings for clinical and safety management
- Keep abreast of relevant scientific literature and clinical trial designs to build capacity
- Serve as a resource for training of clinical and scientific topics to Network staff
- Assist with creating and/or reviewing abstracts, manuscripts and conference presentations as necessary
- Other duties as assigned.
- Medical Doctor (M.D or equivalent degree) or International Equivalent in Obstetrics and Gynecology, Family Planning, Public Health, or a Related Medical Specialty / Sub Specialty or equivalent related education and experience.
- Licensed MD; Board Certification in internal medicine, family practice or infectious diseases is preferred
Experience and Skills:
- Typically requires 12+ years of experience in clinical trial experience in a non-governmental organization (NGO), academia, CRO, or pharmaceutical industry.
- Experience working with infectious diseases, particularly respiratory diseases (treatment, prevention, related clinical trials)
- Proven leadership experience in a cross-functional global team environment, ability to interact externally and internally to support CoVPN.
- Comprehensive knowledge of theories, concepts and practices used in analysis of clinical research studies and clinical trials.
- Demonstrated knowledge of medical clinical pharmacology.
- Extensive knowledge of clinical trial methodology and development process, regulatory requirements governing clinical trials.
- Strong critical thinking and problem-solving skills to plan, organize, and manage resources for successful completion of projects.
- Ability to handle multiple concurrent projects
- Ability to take initiative, demonstrating creative problem-solving skills and decisiveness.
- Ability to motivate, influence and collaborate with others across all levels of the organization.
- Excellent oral and written communication skills.
Problem Solving & Impact:
- High-level analytical skills to identify appropriate courses of action. Identifies potential risks to portfolio execution and recommends corrective actions.
- Identifies and incorporates constraints into the portfolio process and recommends solutions.
- Decisions and actions have a significant impact on management and division operations. Problems encountered are complex and highly varied.
- Exercises judgment to meet business strategies and develops objectives that align with organizational goals.
Typical Physical Demands:
- The ability to work in an office environment sometimes long hours on a computer. An employee needed for 50% or more time.
Technology to be Used:
- Typical office environment. Ability to spend long hours looking at computer screen and doing repetitive work on a keyboard. Ability to sit and stand for extended periods of time. Ability to lift 5 - 25 lbs
- 10% - 25%
This job description summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.
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