Non-Clinical Advisor V

Please note that this position is contingent upon the successful award of a contract currently under bid.

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 Non-Clinical Advisor V shall serve as the technical interface between non-clinical stakeholders and contractors in order to establish study designs and achieve regulatory quality standards.

Essential Job Functions:

• The contractor shall perform a leadership role, problem-solving technical issues related to non-clinical studies and communicating solutions and emerging risks, accurately and timely.
• The contractor shall 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).
• The contractor shall work with diverse product development teams, to include Government personnel and other performers (e.g., statisticians, veterinary anatomic pathologists, veterinary clinical pathologists, toxicologists, clinicians, pharmacologists, formulation scientists, etc.).
• 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 derive interpretations from data and design subsequent experiments with minimal oversight in support of non-clinical testing under the Animal Rule.
• The contractor shall review all aspects of testing and data analysis to generate detailed and well-documented recommendations to be provided as guidance for a path forward.
• The contractor shall contribute critical scientific and regulatory elements for high-quality nonclinical study protocols, to include:
  • Early review of 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 to the report
• The contractor shall 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 explanatory is provided for each data set
  • Adherence to compliance with appropriate regulatory standards
• 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 other performer(s).
• The contractor shall 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)
• The contractor shall review other performers' implementation of activities to ensure they are in compliance with Good Laboratory Practice, standard operating procedures, protocols, and regulations related to ethics and animal welfare.
• The contractor shall ensure that experimental data are being properly collected
• The contractor shall participate in performer site visits and/or on-site audits as needed
• The contractor shall maintain current technical knowledge and skills, applying them to the job as necessary. The contractor shall work independently and as part of a team.
• The contractor shall ensure appropriate subject matter experts are involved in the day-to-day management of non-clinical studies (e.g., biostatistician, toxicologist, biologists, clinicians, pharmacologists, etc.).
• The contractor shall participate in source selection panels as a subject matter expert in reviewing relevant sections of submitted proposals.
• The contractor shall provide technical, scientific, and programmatic support to the program office and project teams, providing advice and assistance for advanced development efforts (i.e., clinical, non-clinical, and manufacturing) related to medical countermeasures for CBR threats.
• The contractor shall assist with Government oversight of development contractor efforts, to include conducting site visits, assisting in monitoring performance and quality standards, and providing technical oversight during study execution.
• The contractor shall establish a link between clinical and non-clinical efficacy, developing a robust manufacturing strategy and defining product development schedules.
• The contractor shall conduct data analyses and create and submit study results to use in market research or publications. The contractor shall provide program office support and participation at conferences and stakeholder meetings.
• The contractor shall participate in internal and external IPTs, to include organizing meetings, preparing agendas, and documenting meeting minutes and action items.
• The contractor shall draft reports, to include executive summaries, significant actions, manuscripts, and other technical documents (e.g., technology transition agreements, concept transition agreements, requests for proposals, statements of work, etc.).
• The contractor shall research and review scientific literature and databases to identify technical information and provide references to support product development efforts.
• The contractor shall review scientific data, reports, and technical submissions.
• The contractor shall effectively communicate results of assigned tasks and efforts, both orally and in written form, in a clear and concise manner, to include executive summaries, meeting presentations, documentation, and reports.
• The contractor shall deliver written work products no later than the assigned suspense (which will be earlier than those established by external sources (e.g., SASI, DSS, higher headquarters suspense dates, etc.) to allow for Government review, revision, and coordination prior to Government approval and submission).
• The contractor will be required to write reports and briefs.
• The contractor will be required to review the reports and briefs of other agencies.
• The contractor shall provide scientific/technology advice, technical oversight, and project management support in the areas of science and technology availability, technology maturity, and applicability of proposed candidate CBRN medical countermeasures through advanced development, production, and fielding.
• The contractor shall provide support at a level commensurate with the educational requirements of the position. The contractor shall provide support to the CTO, including but not limited to the following actions:
  • Representing CTO on IPTs and at other meetings
  • Performing task management
  • Drafting and reviewing documents
  • Summarizing publications and data
• The contractor shall collaborate with project teams and participate in the evaluation of technical results in multiple developmental areas, developing strategies to move the program forward.
• The contractor shall provide written technical opinions to guide the decision making process of the IPT.
• The contractor shall collaborate with both internal and external partners, contributing to data analyses in order to create and submit study results to publications or the FDA.
• The contractor shall assist with outreach activities, including but not limited to the following actions:
  • Organizing visits
  • Preparing agendas
  • Providing information to visitors
  • Documenting meeting summaries and action items
• The contractor shall assist the program managers in assessing schedule risks and developing mitigation strategies.
• The contractor shall author, edit, and contribute in the development of robust product development plans to support FDA approval under the Animal Rule.
• The contractor shall develop drafts and assist the project team to coordinate responsibilities, oversee quality management, and encourage timeliness of completion of protocols, IND applications, other regulatory submissions, and technical reports.
• The contractor shall provide advice for the development of research projects to produce effective solutions for maintaining cost, schedule, and performance parameters.
• The contractor shall provide technical input to acquisition documentation and presentations in support of major milestones, program reviews, or other program presentations.
• The contractor shall develop drafts and/or review and provide edits/comments to technical documentation (i.e., development/technology transfer reports, batch records, standard operating procedures, and regulatory submissions).
• The contractor shall prepare and/or review draft protocols and study plans pertaining to a range of developmental efforts (i.e., manufacturing, non- clinical, clinical, and assay development), providing feedback in support of advanced development efforts.
• The contractor shall prepare documentation/presentations to summarize technical results, to include displaying results in "Layman's" terms, formulating conclusions, and developing technical strategies in response to the data outcomes.
• The contractor shall maintain current knowledge on new technologies and methodologies that may benefit the program, assessing technical proposals critically and effectively, providing written technical opinion on the feasibility of new technologies, and organizing brown bag seminars to allow the Joint Product Offices to review the technologies.
• The contractor shall provide bi-weekly update reports to the CTO.

Necessary Skills and Knowledge:

• Shall possess the ability to independently design, critically evaluate, and execute non-clinical studies.
• The contractor shall possess a familiarity and understanding of regulatory guidelines (i.e., FDA GLP and/or GMP) and regulatory/quality compliance requirements.
• The contractor shall possess strong interpersonal and communication skills, both oral and written.
• The contractor shall possess strong critical thinking, analytical, and problem solving skills, as well as good organization skills to balance and prioritize work.

Minimum Qualifications:

• PhD in Chemistry, Biology, Toxicology or a related discipline, as well as Fifteen (15) years of general experience and ten (10) years of relevant experience.
  • Tradeoff Requirement: Master's degree in Chemistry, Biology, Toxicology, or a related discipline, as well as Twenty (20) years of general experience and ten (15) years of relevant experience.
• Shall possess strong technical training in non-clinical studies to support medical countermeasures in preclinical studies for an IND.
• The contractor shall possess five (5) years of experience designing and conducting non-clinical studies for IND enabling medical countermeasures efforts.
• Clearance: Secret

Preferred Qualifications:

• Experience in a regulated laboratory environment is preferred.

Pay and Benefits

The salary range for this position is $150,000 to $175,000 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.