Scientist V

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 Scientist 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:

• The contractor shall provide expert analysis and advice on the development, management, and improvement of a regulatory organization.
• The contractor shall define and document regulatory strategy; provide analysis of candidate maturity; and draft, review, and approve requisite target product profiles of candidates considered promising for advanced development.
• The contractor shall advise on, review, and evaluate the presentation of data standards in accordance with current regulatory guidance.
• The contractor shall implement quality systems and procedures to ensure compliance with all applicable laws, regulations, and organizational quality standards in support of advanced development activities.
• The contractor shall define, draft, and implement the regulatory and quality infrastructure necessary to support all research and development efforts.
• The contractor shall participate as a regulatory point of contact during product development efforts in order to facilitate cross-communication. In addition, the contractor shall present, orally and in writing, the outcome of these efforts in a timely manner.
• The contractor shall determine which studies require GLP and provide contract oversight, as well as those studies not requiring GLP yet appropriate quality levels.
• The contractor shall participate in medical systems acquisition management activities (e.g., IPT meetings, reviewing acquisition documentation, etc.) and present the outcome, orally and in writing, in a timely manner.
• The contractor shall travel for presentations and seminars and conduct and provide oversight of supplier evaluation visits (e.g., due diligence, mock audits, vendor qualifications, etc.). This will include the following:
• Inspection of contract laboratories or other facilities, providing data in support of GLP studies to assure compliance with GLP guidelines, applicable protocols, and SOPs
• Periodic facility audits of facilities, equipment, and records required by GLPs
• QMS audits of ISO/FDA elements related to the control of documents and data
• Regulatory agency inspections, including sponsor/monitor inspections and clinical investigator site inspections
• GCP training and the development and maintenance of GCP-related quality systems
• GCP compliance audits of investigator sites, CRO facilities, and vendors, including clinical sample labs in accordance with audit plans
• Internal and external current GMP audits in support of the supplier evaluation program to identify and evaluate all risks
• In addition, the contractor shall provide expert analysis and advice in the follow-up actions (e.g., formal reports, updates of related databases, etc.) of these audits and inspections.
• The contractor shall assist Headquarters elements in their understanding of the scientific complexity of the research and development efforts and compliance with regulatory and quality regulations surrounding those efforts.
• The contractor shall analyze any regulatory issues, providing corresponding risk assessments and guidance on developmental paths forward and presenting/defending these analyses orally and in writing.
• The contractor shall apply regulatory analyses based on FDA regulations, regulatory policies, and DoD regulations and guidance across the JPEO-CBRND Medical portfolio and present findings, orally and writing.
• The contractor shall assess the JPEO-CBRND Medical portfolio for sound science and regulatory compliance with FDA regulations and provide assessment and analysis of associated risks, orally and in writing, in a timely manner.
• The contractor shall format regulatory submission in the eCTD format.
• The contractor shall assist the Risk Manager in risk identification and analysis, as well as development of mitigation plans.
• The contractor shall plan (i.e., develop meeting agendas), participate in, and provide support (i.e., develop meeting minutes and track action items) to the RA/QA working group.
• The contractor shall review and assess JPEO-CBRND Medical portfolio documents and relevant medical science and technology program documents to assure alignment to advance development efforts (e.g., being able to develop a new drug under FDA rules, and be an advocate for drug development based on FDA rules/regulations, etc.).
• The contractor shall attend relevant briefings, presenting the outcome and providing reviews and assessments, orally and in writing, in a timely manner.
• The contractor shall assist in the design, development, and implementation of an electronic document management system that will manage (i.e., draft, edit, and approve) documentation, as well as serve as a repository for approved documents with search and retrieve capabilities.
• The contractor shall provide statistical oversight of ongoing clinical and non-clinical studies and manufacturing development (e.g., process validation, sample sizes, stability studies, etc.).
• The contractor shall develop innovative statistical methods for non-clinical and clinical study protocols to support investigational and marketing applications.
• The contractor shall propose, develop, evaluate, and verify statistical methodologies performed to support non-clinical and clinical projects (e.g., study designs, sample size calculations, data quality, randomization, etc.).
• The contractor shall propose, develop, evaluate, and verify statistical methodologies performed to qualify and validate assays, manufacturing processes, and stability studies.
• The contractor shall review study reports, published literature, and project documents as needed to develop white papers and position papers to support historical perspectives or present and support innovative statistical methodologies.
• The contractor shall provide statistical training for non-statistical groups.
• The contractor shall educate and advise non-statisticians (e.g., project management, clinicians, scientists, etc.) on statistical methodologies and approaches, analytical issues to findings, and the process to identify and discuss risks.
• The contractor shall participate as the statistical subject matter expert during IPT meetings, providing guidance to scientific and non-scientific personnel on the planning of clinical and non-clinical studies.
• The contractor shall participate as the statistical subject matter expert during official and unofficial meetings with regulatory agencies (e.g., FDA, etc.) and be capable of defending the proposed statistical plan.
• The contractor shall develop Statistical Analysis Plans (SAPs) for studies to support approval of new drugs, biologics, and/or medical devices.
• The contractor shall analyze data and study reports and provide statistical interpretations for regulatory submissions (e.g., integrated summary of safety and integrated summary of efficacy submissions, etc.).

Necessary Skills and Knowledge:

• Expert knowledge in bioengineering, biology, chemistry, and related scientific fields, and have previous experience applying this knowledge to CBD and bio-surveillance efforts, as well as complex technical problems, with minimal supervision.
• The ability to work on a multi-disciplined team in a DoD acquisition environment.
• The ability to perform multiple task simultaneously and rapidly redirect efforts based on changing requirements.
• Strong writing and oral communication skills.

Minimum Qualifications:

• Master's degree in Engineering, Science, Business Management, Systems Management, or a related discipline, as well as fifteen (15) years of general experience and ten (10) years of relevant experience.
  • Tradeoff Requirement: Bachelor's degree in Engineering, Science, Business Management, Systems Management, or a related discipline, as well as twenty (20) years of general experience and fifteen (15) years of relevant experience.
• Only candidates eligible for a Secret level clearance will be considered (US Citizenship required).

Preferred Qualifications:

• Active Secret clearance preferred

The salary range for this position is $130,000 to $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.