Jobs at Allucent

Leads pharmacometric modeling and simulation, population PK analyses, clinical pharmacology study design, and regulatory documentation. Provides strategic guidance to clients, represents them in regulatory interactions, mentors pharmacometricians, supports business development, and advances PK/PD methodologies. The role requires deep drug development, clinical pharmacology, pharmacometrics, regulatory submission, and client relationship expertise.

Build and maintain scalable AI applications and microservices using Python, FastAPI, Azure OpenAI, and modern web technologies. Design RAG pipelines with Azure Cognitive Search and Cosmos DB, integrate external search APIs such as Perplexity and Bing, and support AI-driven data-processing workflows. Manage version control and CI/CD with Git and Azure DevOps, optimize prompts, embeddings, and generative models, and document APIs and AI workflows.

Designs, deploys, manages, and optimizes cloud and IT infrastructure across Azure, AWS, Azure DevOps, and Microsoft 365. Responsibilities include monitoring performance, troubleshooting, ensuring high availability, strengthening security and compliance, supporting disaster recovery, leading infrastructure projects, and mentoring junior engineers. The role also develops automation and infrastructure best practices, supports hybrid cloud integration, and contributes to team learning and standardization.

Provides independent medical monitoring and clinical safety oversight for assigned biopharmaceutical trials. Reviews adverse events, safety reports, clinical data, protocols, and study documents; supports DSMBs, dose-escalation meetings, risk planning, protocol deviation reviews, regulatory compliance, and medical training. Serves as a medical resource for investigators, study teams, clients, and clinical sites, provides urgent safety advice, and contributes to therapeutic conferences, client evaluations, and bid presentations.

Leads regulatory affairs projects for drug, biologic, and medical device development. Advises clients on global regulatory strategies, health authority interactions, submissions, and CTD requirements. Oversees regulatory teams, reviews and authors scientific and regulatory documents, mentors staff, and translates regulations into practical development and lifecycle plans.

Independently monitor oncology clinical trials across study phases, including site initiation, routine monitoring, and close-out visits. Ensure compliance with protocols, ICH-GCP, SOPs, and regulations; maintain investigator relationships; support high-quality data collection; identify and resolve site issues; escalate risks affecting trial integrity and patient safety; and mentor junior team members. The six-month, half-time contractor role is remote with travel throughout Hungary and the United States.

Leads enterprise business application engineering, Salesforce Sales Cloud administration, product ownership, support triage, solution design, integrations, and release delivery. Partners with stakeholders to prioritize roadmaps, translate requirements, configure and optimize applications, coordinate testing and deployments, resolve complex issues, maintain compliance, improve business processes, and mentor engineers. The role includes Salesforce configuration, security, reporting, data quality, integration troubleshooting, documentation, governance, and technical leadership across corporate systems.

Lead population PK/PD modeling and simulation projects, design and interpret clinical pharmacology studies, mentor pharmacometricians, provide strategic regulatory guidance and author regulatory documents, manage client relationships, and support business development to advance drug development programs.

Lead population PK/PD modeling and simulation efforts, design and interpret clinical pharmacology studies, provide strategic guidance to clients, author regulatory documents, represent clients in regulatory interactions, mentor pharmacometricians, and support business development and process improvement.

Lead and manage clinical data management for studies from database design and set-up through cleaning, validation and database lock. Coordinate with cross-functional teams and external vendors, develop DM plans and standards (CDISC/CDASH), oversee UAT, data transfers/reconciliation, metrics reporting, quality reviews, audits, training and mentoring, and contribute to process and tool improvements and client interactions.

Coordinates local clinical trial start-up activities in Germany, including regulatory authority and ethics committee submissions, essential document collection, site contracts, budgets, regulatory communications, and site readiness through Site Initiation Visit. Maintains study tracking systems and electronic trial master files, supports document review and discrepancy resolution, monitors local regulatory updates, and coordinates investigational product shipment authorization. Requires pharmaceutical or biotechnology regulatory affairs experience and fluency in English and Spanish.

Lead monitoring activities for clinical trials across all phases, ensuring compliance with ICH-GCP, protocols, SOPs and regulations. Manage site relationships, site activation/start-up tasks, resolve site issues, and travel throughout Germany to perform initiation, routine monitoring, and close-out visits.

Independently lead monitoring for assigned clinical trials (initiation, routine, close-out), ensure compliance with protocol, ICH-GCP, SOPs and regulations, build strong site relationships, identify and resolve site issues, and support regulatory affairs, site activation, contracting, and study-startup. Frequent travel across Germany and collaboration with sponsors and investigators.

Lead and manage clinical data management for studies from database design and eCRF development through cleaning, UAT, transfers, locking and close-out. Develop DM documents, ensure regulatory compliance, coordinate cross-functional teams, mentor staff, support proposals/RFPs, and improve DM processes and standards.

Serve as the local pharmacovigilance contact for post-marketing programs: liaise with local regulators, monitor safety and legislation changes, support audits, perform local literature screening, manage risk-minimization and local PV records, report to the EU QPPV, provide PV training, and deliver monthly activity reports for freelance engagements in Poland.

Lead and manage CRAs and clinical functions for global or regional trials, ensuring planning, implementation, monitoring, timelines, budgets, quality, training, mentoring, and cross-functional coordination with Project Management and sponsors.

Lead global clinical trials from start-up through closeout, manage cross-functional teams and vendors, ensure GCP and regulatory compliance, control budgets and risks, maintain inspection-ready Trial Master File and stakeholder communication to deliver high-quality multispecialty studies.

Independently monitor and manage assigned clinical trial sites across phases, ensure compliance with protocol, GCP/ICH and SOPs, build site relationships, identify and resolve issues, mentor junior CRAs, and travel throughout the United States to support study integrity and patient safety.

Lead and oversee global oncology clinical trial projects, manage budgets and proposals, ensure quality and compliance (ICH-GCP, privacy, local regs), serve as primary client contact, lead project teams, drive customer satisfaction and continuous process improvement.