Sitero

Medical Director

• Provide strategic input into current and potential clinical projects
• Support site investigators
• Manage medical monitoring and all medical aspects of clinical trials
• Provide strategic input for proposal writing and bid-defense meetings
• Support data review and medical writing for protocols and study-specific reports, including regulatory annual reports and clinical study reports
• Support FDA interactions, including IND and IDE support and related meetings
• Review and address site and CRA queries regarding inclusion/exclusion criteria
• Prepare listings of protocol deviations and adverse events for regular meetings
• Perform initial review for coding and reconcile coding based on clinical and medical team input
• Develop strategies for FDA submissions
• Develop protocols
• Prepare drafts of appropriate study plans
• Assist medical monitoring in clinical trial management

Medical Director – Contract

Vice President

• Define and execute the go-to-market strategy for Sitero's integrated AI-powered technology and clinical services offering
• Set global revenue targets and own pipeline, forecasting, and bookings across service and technology offerings
• Partner with product, medical, and delivery leadership to keep the commercial motion ahead of the market
• Design distinct sales motions, processes, and team structures for software and clinical services sales cycles
• Engage CTOs, CMOs, and VPs of Clinical Operations evaluating eClinical solutions and Phase I-IV trials
• Lead complex, multi-stakeholder deal cycles from first engagement through close
• Bring SiteroAI to market and articulate efficiency gains across the clinical development lifecycle
• Collaborate with product and science teams to ground the AI narrative in demonstrated outcomes
• Recruit, develop, and lead a global commercial team spanning business development, account management, marketing, and commercial operations
• Build scalable commercial infrastructure, including processes, tools, compensation plans, and forecasting
• Own executive-level relationships with key sponsors and partners
• Position Sitero as a long-term strategic partner rather than a transactional vendor

Vice President, Commercial

• Define and execute the go-to-market strategy for Sitero's integrated AI-powered technology and clinical services offering
• Set global revenue targets and own pipeline, forecasting, and bookings across service and technology offerings
• Partner with product, medical, and delivery leadership to keep the commercial motion ahead of the market
• Design distinct sales motions, processes, and team structures for software and clinical services sales cycles
• Engage CTOs, CMOs, and VPs of Clinical Operations evaluating eClinical solutions and Phase I-IV trials
• Lead complex, multi-stakeholder deal cycles from first engagement through close
• Bring SiteroAI to market and articulate efficiency gains across the clinical development lifecycle
• Collaborate with product and science teams to ground the AI narrative in demonstrated outcomes
• Recruit, develop, and lead a global commercial team spanning business development, account management, marketing, and commercial operations
• Build scalable commercial infrastructure, including processes, tools, compensation plans, and forecasting
• Own executive-level relationships with key sponsors and partners
• Position Sitero as a long-term strategic partner

Clinical Operations

• Own end-to-end delivery of clinical programs across Sitero’s client portfolio
• Oversee CRAs, CTMs, and project management staff across Phase I–IV programs
• Ensure delivery against timelines, budgets, quality, and protocol adherence commitments
• Serve as executive sponsor and escalation point for complex, high-risk, or high-value studies
• Define and refine clinical operations SOPs, working practices, and quality standards
• Build resourcing models, capacity planning frameworks, and portfolio performance metrics
• Lead selection, implementation, and optimization of EDC, CTMS, eTMF, and risk-based monitoring systems
• Recruit, develop, and retain the clinical operations team
• Establish career pathways and competency frameworks for clinical operations
• Partner with Business Development on proposals, bid defense meetings, and scope development
• Serve as senior sponsor contact from kickoff through closeout
• Translate sponsor needs into realistic, risk-aware, adequately staffed operational plans
• Champion risk-based monitoring and quality by design
• Ensure inspection readiness and lead preparation for sponsor audits and regulatory inspections
• Monitor emerging FDA, EMA, and ICH E6 R3 guidance and ensure organizational alignment

Senior Director, Clinical Operations

Product Manager

• Lead the product vision and roadmap across Sitero's eClinical and eCompliance technology portfolio
• Own the end-to-end product lifecycle for Sitero's platforms
• Define and champion a multi-year product roadmap aligned with customer needs and Sitero's single-vendor, full-transparency model
• Lead and develop a team of product managers
• Collaborate with clinical operations, drug safety, biostatistics, data management, engineering, and commercial teams
• Accelerate adoption of SiteroAI and Ash AI across study configuration, data management, and portfolio insights
• Maintain relationships with sponsor and site stakeholders and serve as a voice of the customer
• Monitor the CRO and eClinical technology competitive landscape
• Build and lead the Customer Advisory Board program
• Represent product leadership in EBC meetings, QBRs, client settings, and industry conferences
• Partner with commercial and account management teams to drive customer value and identify expansion opportunities
• Support business development through RFP responses, client presentations, and partnership discussions
• Ensure platform compliance across North American and global markets

Vice President, Product Management

AI Engineer

• Design robust, scalable architectures for cloud-native AI-powered applications
• Deploy and manage foundation models using AWS Bedrock
• Orchestrate complex prompt workflows
• Build and maintain secure, high-performance APIs and microservices using Python, Java, or Node.js
• Implement Retrieval-Augmented Generation (RAG) pipelines connecting internal corporate data with language models
• Optimize application latency, token throughput, and compute costs for AI inference
• Partner with product teams to build AI agents
• Mentor junior engineers on engineering best practices

Senior AI Developer

Medical Reviewer

• Analyze, review, and interpret non-clinical and clinical safety data
• Perform medical review of ICSRs and other drug safety information from clinical trials, spontaneous and solicited reports, aggregate reports, and literature reports
• Provide technical and medical expertise in ICSR causality assessment and assess quality within the ICSR process
• Identify process improvement opportunities and drive changes
• Contribute to aggregate safety reports, including development safety update reports and periodic benefit-risk evaluation reports
• Provide medical input on new and existing safety documents to ensure regulatory compliance
• Contribute to Standard Operating Procedures, Working Instructions, and guidance documents
• Contribute to safety and pharmacovigilance training programs
• Provide safety training at investigator meetings
• Collaborate with Regulatory Affairs on reporting pharmacovigilance and drug safety information to regulatory agencies and prescriber communities
• Serve as a subject matter expert for drug safety and pharmacovigilance service vendors
• Train and mentor Pharmacovigilance Physicians and Specialists
• Ensure compliance with global PV regulations and guidelines, including CIOMS, FDA, PMDA, EMA, and ICH
• Maintain medical knowledge and current knowledge of drug safety, pharmacovigilance regulations, safety surveillance, and risk-management practices
• Collaborate with Sitero safety teams, CROs, and partners on benefit-risk assessment and safety communication

Medical Director – Contract

Vice President, Commercial

Vice President, Commercial

Senior Director, Clinical Operations

Vice President, Product Management

Senior AI Developer

Medical Reviewer – ICSR