Clinical Advisor V

Overview

Goldbelt Apex, a part of the Healthcare Technology Transformation Group, is a data-focused company dedicated to process and quality in every aspect. As experts in healthcare IT experts, Apex is committed to building systems for healthcare organizations to seamlessly communicate and exchange data across different systems and devices.

Summary:

Goldbelt Apex LLC is seeking a qualified Clinical Advisor V to support our Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear (JPEO-CBRND) Joint Project Manager for Medical Countermeasure Systems (JPM MCS) client at our Ft. Detrick, MD location. This position requires an active Secret clearance. You must be a U.S. citizen.

Responsibilities

Essential Job Functions:

• Serve as the clinical representative on project teams and support risk planning efforts in developing medical countermeasures for chemical and biological WMD threats

• In collaboration with project team members, write clinical development plans

• Develop drafts and assist the project team in coordinating responsibilities, overseeing quality management, and encouraging the timeliness of completion of clinical study reports, IND applications, investigator brochures, CTAs, ISSs, ISEs, and other regulatory submissions and clinical expert reports

• 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.)

• 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

• Review draft clinical protocols and provide feedback.

• Review and search medical literature and databases to identify clinical and technical information and to provide references to support clinical plans.

• Author, edit, and contribute to the preparation of technical reports, such as overall project concepts and descriptions, test plans, and technical reports

• Work closely with nonclinical teams to bridge nonclinical outcomes to the clinical disease course. Develop a basic understanding of critical assays to establish a correlate of protection.

• 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)

• 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

• Ensure that clinical data are being correctly collected

• Participate in audits/site visits as needed

• Maintain current technical knowledge and skills, applying them to the job as necessary

• Work with Integrated Product Teams (IPTs) comprised of civilians, military and non-government personnel, and matrix support staff with diverse areas of expertise, including program managers, budget analysts, regulatory specialists, acquisition analysts, and logisticians

• Work with diverse product development teams, including Government personnel and the CRO or other performers, such as statisticians, biologists, toxicologists, clinicians, pharmacologists, and formulation scientists

• Represent the organization, communicating with individuals both in and outside the organization, including customers, the public, other Government agencies, and external sources

• Maintain communication with supervisors, peers, or subordinates via telephone, e-mail, or in person, as required

• Develop and maintain constructive and cooperative working relationships with others

• 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:

• Knowledge of disease pathology in humans and linking that to the nonclinical efforts, specifically in the areas of filoviruses, plague, botulinum, and chemical nerve agents

• Knowledge of FDA submissions and associated FDA regulations and guidelines. Knowledge of working with CBER is preferred, as well as experience with programs in phase 2 and phase 3 clinical trials

• Strong interpersonal and communication skills, both oral and written, including academic and technical writing experience in the fields of infectious disease and biodefense demonstrated via publications on relevant animal models and clinical trials

• Ability to independently design clinical protocols

• 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

• Ten (10) years of general medicine experience, including five (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

• 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

• Experience working as a principal investigator for clinical trials within the Special Immunization Program (SIP) at USAMRIID

• Active Secret clearance preferred; only candidates eligible for a Secret level clearance will be considered (US Citizenship required)

The salary for this position is a minimum of $155,000 per year.

Pay and BenefitsAt 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.