Non-Clinical Advisor V / Animal Model

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 Non-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.

Essential Job Functions:

• Serve as the technical interface between non-clinical stakeholders and contractors to establish study designs and achieve regulatory quality standards.
• Perform a leadership role, problem-solving technical issues related to nonclinical studies and communicating solutions and emerging risks accurately and timely to the Vaccine Manager, Deputy JPM, and other staff members.
• Work with IPTs comprised of civilians, military and non-government personnel, and matrix support staff with diverse areas of expertise (i.e., PMs, budget analysts, regulatory specialists, acquisition analysts, and logisticians).
• Work with diverse product development teams, including Government personnel and other performers (e.g., statisticians, veterinary anatomic pathologists, veterinary clinical pathologists, toxicologists, clinicians, pharmacologists, formulation scientists, etc.).
• Represent the organization, communicating with individuals both inside and outside the organization, including customers, the public, and other Government agencies and external sources.
• Derive interpretations from data and design subsequent experiments with minimal oversight in support of non-clinical testing of vaccines under the Animal Rule.
• Review all aspects of testing and data analysis to generate detailed and well-documented recommendations that will provide guidance for a path forward.
• Contribute critical scientific and regulatory elements for high-quality nonclinical study protocols, including:
  • Reviewing proposals for advising PMs and external performers of expectations in the forthcoming study protocol content
  • Ensuring that relevant, Industry-standard scientific practices are included to prevent both a)
  • critical data gaps at the time of interpretation and b) excess, unnecessary efforts that do not serve the furtherance of study objective(s)
  • Ensuring that the study protocol uses correct scientific and regulatory designations, terminology, and section formatting to serve as the framework for the report
• * Conduct draft report reviews of non-clinical studies based on exhaustive data review to ensure:
  • Technical and scientific data integrity
  • Correct or defensible written interpretation of data (as indicated)
  • Reporting limited to the scope of data within the study
  • Appropriate written explanation is provided for each data set
  • Adherence to compliance with appropriate regulatory standards
• Provide consultation to clients in the design of experimental studies and protocols, interpretation of experimental results, review of study reports, and recommendations from other performer(s).
• Interpret the meaning of information for others, to include:
  • Translating or explaining what the information means and how it can be used
  • Generating, interpreting, and communicating results from in vivo nonclinical studies to teams, including other advanced development scientists, PMs, and non-scientists)
• Review other performers' implementation of activities to ensure they comply with Good Laboratory Practice, standard operating procedures, protocols, and regulations related to ethics and animal welfare.
  • Ensure that experimental data are being correctly collected
  • Participate in performer site visits and on-site audits as needed
• Maintain current technical knowledge and skills, applying them as necessary.
• Maintain communication with supervisors, peers, or subordinates via telephone, e-mail, or in person.
• Work independently and as part of a team.
• Ensure appropriate subject matter experts (e.g., biostatisticians, toxicologists, biologists, clinicians, pharmacologists, etc.) are involved in the day-to-day management of non-clinical studies.
• Participate in source selection panels as a subject matter expert in reviewing relevant sections of submitted proposals for vaccine development.

Necessary Skills and Knowledge:

• The ability to independently design, critically evaluate, and execute non-clinical studies.
• Familiarity and understanding of regulatory guidelines (i.e., FDA GLP and/or GMP) and regulatory/quality compliance requirements. Experience in a regulated laboratory environment is preferred.
• Strong interpersonal and communication skills, both oral and written.
• Strong critical thinking, analytical, and problem-solving skills and good organization skills to balance and prioritize work.

Minimum Qualifications:

• PhD in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, as well as Fifteen (15) years of general experience and ten (10) years of relevant experience.
  • Tradeoff Requirement: The contractor shall possess a Master's degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, as well as Twenty (20) years of general experience and ten (15) years of relevant experience.
• Strong technical training in non-clinical studies to support medical countermeasures in preclinical studies for an IND.
• Five (5) years of experience designing and conducting medical countermeasures in non-clinical studies for an IND.
• 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 Benefits
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.