** Only US Citizens please apply**
** FEDERAL EXPERIENCE IS AN ADDED ADVANTAGE**
BITS is a growing software development company in Washington DC area. We provide database solutions, application development, infrastructure supports, network engineering, and high-end computing using innovative technologies to the health agencies. We are looking for a Senior Drupal Developer for one of our FEDERAL projects.
Position Summary
This role will provide expert-level support in biomedical ontologies, controlled terminologies, semantic modeling, clinical concept mapping, and ontology-driven knowledge representation to improve the accuracy, consistency, and explainability of AI-assisted clinical trial protocol review.
Key Responsibilities
- Lead ontology and controlled terminology activities to support AI-assisted extraction, analysis, and comparison of clinical trial protocol content.
- Identify, evaluate, and apply relevant biomedical ontologies, controlled terminologies, and clinical data standards to support FDA protocol review use cases.
- Develop semantic mappings for clinical protocol concepts, including therapeutic area, indication, drug class, mechanism of action, endpoints, eligibility criteria, safety risks, study population, interventions, dose selection, study design, and regulatory compliance elements.
- Support the augmentation of generative AI queries with domain-specific ontology, terminology, and conceptual model information to improve extraction accuracy and consistency.
- Work with clinical SMEs and FDA reviewers to define the meaning, relationships, hierarchy, synonyms, and context of key protocol concepts.
- Create and maintain concept maps, terminology crosswalks, synonym libraries, value sets, semantic rules, and ontology-driven metadata structures.
- Support the use of static snapshots of required biomedical ontologies within the project environment for POC development and validation.
- Collaborate with data standardization specialists and data modelers to align ontology concepts with structured data elements, metadata, and clinical information models.
- Support matching algorithms that compare new and historical protocols by therapeutic area, indication, drug class, study design, endpoints, and other clinically meaningful attributes.
- Assist LLM/AI engineers in designing prompts, retrieval logic, semantic enrichment strategies, RAG support, and confidence scoring mechanisms.
- Support validation processes by defining ontology-based accuracy checks, terminology validation rules, semantic consistency checks, and human-in-the-loop feedback mechanisms.
- Analyze ontology gaps, terminology conflicts, ambiguous clinical concepts, synonym issues, mapping limitations, and areas requiring reviewer feedback.
- Support POC workflows for protocol information extraction, reviewer dashboard population, protocol comparison, and Elsa-enabled agentic workflow demonstrations.
- Prepare documentation describing ontology sources, mapping assumptions, semantic models, validation rules, limitations, and recommendations for future expansion.
- Contribute to project deliverables, including extraction process documentation, comparison algorithm documentation, validation processes, feedback processes, POC documentation, future direction recommendations, and the final report.
Required Qualifications
- Bachelor’s degree in Biomedical Informatics, Health Informatics, Life Sciences, Computer Science, Data Science, Clinical Research, Pharmacy, Public Health, or a related discipline.
- 8+ years of experience in healthcare ontology, biomedical informatics, terminology management, semantic modeling, clinical data standards, or related fields.
- Expert-level understanding of biomedical ontologies, controlled terminologies, terminology mapping, and semantic interoperability.
- Strong understanding of clinical trial protocol content, clinical research terminology, and regulatory review information needs.
- Experience applying biomedical vocabularies and terminology systems such as MedDRA, SNOMED CT, LOINC, RxNorm, UMLS, NCIt, CDISC terminology, or similar standards.
- Experience developing concept maps, value sets, terminology crosswalks, semantic relationships, synonym mappings, and ontology-based metadata models.
- Strong knowledge of clinical information modeling and the ability to translate clinical concepts into structured semantic representations.
- Familiarity with ICH M11 structured protocol concepts and the role of standardized protocol content in improving regulatory review efficiency.
- Experience supporting AI, NLP, RAG, semantic search, or generative AI initiatives through ontology enrichment, terminology normalization, and concept-level validation.
- Ability to support comparison of structured and unstructured clinical documents using ontology-informed methods.
- Strong analytical skills and ability to identify ambiguity, gaps, inconsistencies, and semantic conflicts in clinical and regulatory content.
- Excellent written and verbal communication skills, including the ability to document complex ontology decisions in a clear and reviewable manner.
- Ability to work effectively with multidisciplinary teams, including clinical SMEs, FDA reviewers, AI engineers, data modelers, developers, and project managers.
Preferred Qualifications
- Master’s or Ph.D. in Biomedical Informatics, Health Informatics, Clinical Informatics, Life Sciences, Data Science, or a related field.
- Prior experience supporting FDA, HHS, NIH, CMS, or other federal health or regulatory programs.
- Experience with FDA regulatory review environments, clinical trial submissions, CDER workflows, or clinical protocol review.
- Familiarity with the FDA Data Standards Catalogue and regulatory data standards used in clinical and healthcare domains.
- Experience with HL7 FHIR, CDISC, OMOP, RDF/OWL, SKOS, SPARQL, graph databases, knowledge graphs, or semantic web technologies.
- Experience supporting ontology-based AI validation, confidence scoring, explainability, and human-in-the-loop feedback workflows.
- Familiarity with AWS GovCloud, Databricks, vector databases, RAG pipelines, or enterprise AI environments.
- Experience contributing to proof-of-concept development, exploratory AI projects, and technology modernization initiatives.
Key Competencies
- Biomedical ontology and controlled terminology expertise
- Clinical concept mapping and semantic modeling
- Clinical protocol content understanding
- ICH M11 structured protocol familiarity
- Clinical data standards and interoperability
- Ontology-enabled AI query augmentation
- Semantic validation and data quality
- Knowledge graph and metadata design
- Cross-functional collaboration
- Clear technical documentation
Job Type: Full-time
Pay: $155,000.00 - $160,000.00 per year
Work Location: Remote
