Overview Goldbelt Professional Services specializes in providing expert resources for Public Health missions including scientific, technical, and administrative support from junior staff to high-level subject matter experts. Research and data driven, Goldbelt Professional Services’ experts create solutions customized to the client’s needs. Summary: The Clinical Trialist (Clinical Advisor) for the JPM CBRN Task Order 3 contract in the CMO Program Office shall serve as the clinical representative on project teams and support risk planning efforts in the context of development of medical countermeasures for chemical and biological WMD threats. Responsibilities Essential Job Functions: In collaboration with project team members, the contractor shall lead the writing of clinical development plans. The contractor shall develop drafts and assist the project team to coordinate responsibilities, oversee quality management, and encourage timeliness of completion of clinical study reports, IND applications, investigator brochures, CTAs, ISSs, ISEs, and other regulatory submissions and clinical expert reports. The contractor shall collaborate with both internal and external partners, contributing to data analyses to draft and submit clinical study results to publications or the FDA; participate in the evaluation of safety results in clinical studies; assist in formulating the emerging safety and risk/benefit profile of products in development for clinical trials and regulatory documents (e.g., IND, investigator brochure, informed consent, etc.). The contractor shall assist the regulatory team in developing a robust product development plan to support FDA approval under the Animal Rule, assisting the regulatory team in establishing a link between clinical and non-clinical efficacy. The contractor shall review draft clinical protocols and provide feedback. The contractor shall review and search medical literature and databases to identify clinical and technical information and to provide references to support clinical plans. The contractor shall author, edit, and contribute to preparation of technical reports, such as overall project concepts and descriptions, test plans and technical reports The contractor shall work closely with nonclinical teams to bridge nonclinical outcomes to the clinical disease course. Basic understanding of key assays needed to establish a correlate of protection. The contractor shall provide consultation to clients in the design of experimental studies and protocols, interpretation of experimental results, review of study reports, and recommendations from the Clinical Research Organization (CRO) or other performer(s) The contractor shall review the CRO’s or other performers’ implementation of activities to ensure compliance with good clinical practices, standard operating procedures, protocols, and regulations related to ethics of clinical trial execution The contractor shall ensure that clinical data are being properly collected The contractor shall participate in audits/site visits as needed The contractor shall maintain current technical knowledge and skills, applying them to the job as necessary The contractor shall work with Integrated Product Teams (IPTs) comprised of civilians, military and non-Government personnel, and matrix support staff with diverse areas of expertise, to include program managers, budget analysts, regulatory specialists, acquisition analysts, and logisticians The contractor shall work with diverse product development teams, to include Government personnel and the CRO or other performers, such as statisticians, biologists, toxicologists, clinicians, pharmacologists, and formulation scientists The contractor shall represent the organization, communicating with individuals both in and outside the organization, to include customers, the public, and other Government agencies, and external sources The contractor shall maintain communication with supervisors, peers, or subordinates via telephone, e-mail, or in person, as required The contractor shall develop and maintain constructive and cooperative working relationships with others The contractor shall work independently and as part of a team, and must have strong interpersonal and communication skills, both oral and written. Qualifications Necessary Skills and Knowledge: Shall have knowledge of FDA submissions and associated FDA regulations and guidelines. Knowledge working with CBER is preferred as well as experience with programs in phase 2 and phase 3 clinical trials. Must have strong interpersonal and communication skills, both oral and written, including academic and technical writing experience in the fields of infectious disease and biodefense via publications on relevant animal models and clinical trials. Shall possess and demonstrate the ability to independently design clinical protocols. Shall possess strong critical thinking, analytical, and problem-solving skills, as well as good organization skills to balance and prioritize work. Minimum Qualifications: Doctor of Medicine or Doctor of Osteopathy degree, board certified in Internal Medicine and infectious diseases by the American Board of Internal Medicine -AND- >10 years of general medicine experience -INCLUDING- 5 years conducting or supporting clinical trials within multiple government agencies (DOD, NIH, BARDA). Experience managing occupational exposures to Biological Select Agents and Toxins (BSAT) at BSL-3/BSK-4 labs. Shall have in depth senior level experience in clinical protocol development from early vaccine development to late-stage vaccine development, informed consent, IRB approval process, and safety monitoring board. Must have experience working as a investigator for clinical trials within the Special Immunization Program (SIP) at USAMRIID. Clearance: Secret Pay and Benefits The salary range for this position is $170,000 to $270,000 annually. At Goldbelt, we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.