Careers
Join Harbour BioMed and be part of shaping the future of next-generation antibody therapeutics.
Harbour Medical is seeking Clinical Research Associates (CRAs) to join our clinical operations team in support of HM's clinical trials.
As a key liaison between the company and clinical research sites, you will ensure that trials are conducted in compliance with ICH GCP and applicable regulations.
• Site Management
• Independently conduct Site Selection Visits(SSV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and
• Close-Out Visits (COV)
• Build and maintain strong working relationships with Principal Investigators (PIs) and site staff
• Assess site compliance with study protocols, data quality standards, and regulatory requirements
• Support the full lifecycle of clinical projects
• Assist investigators in preparing and submitting IRB/IEC application materials
• Track project progress and provide regular status updates and risk reports
• Data & Document Management
• Perform Source Data Verification (SDV) to ensure consistency between CRF/EDC entries and source records
• Maintain the completeness and accuracy of Investigator Site Files (ISF) and Trial Master File (TMF)
• Prepare monitoring visit reports and follow-up letters; track resolution of outstanding issues
• Safety & Compliance
• Identify and report Adverse Events (AEs) and Serious Adverse Events (SAEs) in a timely manner
• Monitor the integrity of the Informed Consent process
• Oversee Investigational Product (IP) receipt, storage, dispensing, return, and temperature monitoring at site
• Support site readiness for regulatory inspections and sponsor audits
• Ensure all trial activities comply with ICH GCP, NMPA regulations, and company SOPs
• Bachelor's degree or above in Medicine, Pharmacy, Life Sciences, or a related field
• Minimum 2 years of CRA experience with independent monitoring capability
• Strong cross-functional communication and multi-site management skills
• Prior experience with IIT projects is a strong plus
• Experience in oncology, immunology, or biologics is preferred
• Solid knowledge of ICH GCP and NMPA regulations
• Strong written and verbal communication skills in both Chinese and English
• Willingness to travel as required
This role is responsible for building and managing strategic partnerships with multinational pharmaceutical companies (MNC) on behalf of Harbour Medical. Working in complement with the existing BD team's strength in biotech client relationships, this position focuses specifically on engaging top-tier global pharma as co-development partners, licensees, and platform clients.
• Identify, develop, and close co-development and clinical service partnerships with global MNC pharma companies (e.g., AstraZeneca, BMS, Lilly, Roche, Novartis, Pfizer etc)
• Serve as the primary relationship owner for MNC accounts — building trust at VP/SVP BD level within target companies
• Structure and negotiate deal terms (co-dev, fee-for-service, sweat equity, milestone-based) tailored to MNC partnering models
• Develop and maintain a robust MNC pipeline: from initial outreach → due diligence → term sheet → close
• Collaborate with internal teams (Medical, Clinical Ops, Regulatory) to build compelling proposals demonstrating HM's differentiated value vs. traditional CROs
• Represent Harbour Medical at global partnering conferences (BIO, JPM, DIA, ASCO side meetings) and proactively create MNC touchpoints
• Provide market intelligence on MNC outsourcing trends, clinical development strategies, and partnership preferences to inform HM's go-to-market approach
• 12+ years in biopharma BD, licensing, or alliance management — with significant MNC-facing experience
• Established personal network at VP+ level within 3+ global pharma companies
• Track record of closing clinical-stage partnerships or co-development deals with MNC (not just discovery-stage)
• Understanding of clinical development process (IND → Phase 3), regulatory pathways, and CRO/CDMO landscape
• Experience working in or partnering with China-based clinical operations (understanding of China speed/cost advantage for global programs)
• Excellent English communication; Mandarin a plus
• MBA or PhD in life sciences preferred
As the head of AI engineering and product delivery, you will lead the technical architecture, engineering execution, and product strategy for AI-powered clinical trial solutions. You are both a technical leader and a product visionary—responsible for building high-availability, scalable, and compliant AI systems, while also translating cutting-edge AI capabilities into tangible product value that addresses real customer pain points, and driving commercial success through cross-functional leadership.
Product Strategy & Roadmap
• Own the overall product strategy and roadmap for AI-powered clinical trial solutions, defining product positioning, core features, and differentiation based on market insights, customer needs, and competitive landscape.
• Establish product prioritization frameworks, balancing short-term delivery with long-term technology investments to ensure continuous alignment with business objectives.
Engineering Architecture & Technical Leadership
• Lead the overall technical architecture design of AI products, building high-performance, secure, and compliant RAG pipelines, Agent workflows, and microservices architectures.
• Oversee technology stack selection, system performance optimization, and technical debt management, ensuring scalability, stability, and maintainability of the system.
• Lead the full lifecycle engineering of LLM applications (e.g., intelligent document processing, automated query generation, monitoring assistants, protocol writing assistance) from proof-of-concept to large-scale production deployment.
Team Development & Management
• Build and lead cross-functional engineering and product teams, including backend, frontend, DevOps, product managers, and UI/UX designers.
• Establish efficient product development processes (e.g., Agile/Scrum), driving continuous improvement in quality, efficiency, and innovation.
• Own team recruitment, development, performance management, and career growth.
Compliance, Quality & Safety
• Lead the design and implementation of AI safety guardrails, evaluation frameworks, and observability solutions to ensure AI outputs meet the stringent accuracy, traceability, and compliance requirements of the life sciences industry (e.g., GCP, 21 CFR Part 11, FDA guidance).
• Drive the adoption of CI/CD and MLOps/LLMOps best practices to ensure reliable system delivery.
Customer & Commercial Engagement
• Partner closely with customer success, business development, and clinical operations teams, participating in key client demos and requirements discussions to translate technical capabilities into customer-perceived value.
• Monitor industry trends and competitive intelligence, continuously refining product positioning and competitiveness.
Education
• Master's degree or above in Computer Science, Software Engineering, Information Technology, or a related field (exceptional candidates with a Bachelor's degree may be considered).
Experience
• 8+ years of experience in software engineering or AI product development, with at least 3+ years in engineering or product team management roles.
• Proven experience leading AI-driven products from 0 to 1, particularly in life sciences, clinical research, or healthcare, is highly preferred.
Technical Skills
• Expert-level proficiency in Python, Java, or TypeScript, with deep understanding of cloud-native architectures (AWS/Azure/GCP), microservices, and RESTful API design.
• Deep expertise in LLM application development frameworks (e.g., LangChain, LlamaIndex), vector databases, and Agent architecture design.
• Familiarity with MLOps/LLMOps toolchains and methodologies, with hands-on experience in architecting and operating production-grade AI systems.
• Knowledge of clinical data systems (e.g., EDC, CTMS, ePRO) and 21 CFR Part 11 compliance requirements is a plus.
Core Competencies
• Strong combination of technical depth and product mindset, with the ability to bridge technology and business needs across domains.
• Exceptional cross-functional leadership and communication skills, capable of building consensus and driving execution across engineering, product, clinical, and commercial teams.
• Strong customer orientation and results-driven mindset, with genuine passion for applying AI to solve real-world challenges in healthcare and life sciences.
As a key leader in AI and computational sciences, you will be responsible for building and leading the team that applies cutting-edge machine learning, deep learning, and generative AI technologies across the entire clinical trial lifecycle. You will not only drive the R&D and innovation of complex algorithms but also define the technology roadmap from a strategic perspective, advancing AI models from research to productization, ultimately achieving a step-change improvement in clinical trial efficiency through data-driven intelligence.
Strategy & Technology Leadership
• Define and execute the mid-to-long-term technology strategy for AI modeling and computational sciences, identifying and evaluating the application potential and business value of emerging AI/ML technologies (e.g., LLMs, multimodal learning, time-series forecasting, graph neural networks) in clinical trial scenarios.
• Lead key technology selection and architectural decisions, ensuring technical excellence, scalability, and regulatory compliance.
Team Development & Management
• Build, mentor, and manage the algorithm team, including recruitment, performance evaluation, career development, and technical capability building.
• Establish efficient R&D processes and collaboration mechanisms, driving continuous improvement in model development, validation, iteration, and knowledge management.
End-to-End Modeling & Productization
• Lead the team through the full modeling lifecycle—from defining clinical pain points, data mining, feature engineering, model training and tuning, to deployment in production environments.
• Ensure model accuracy, robustness, and interpretability in key applications such as patient enrollment prediction, protocol deviation alerts, and real-world evidence generation.
• Drive the translation of research outcomes into product features, working closely with engineering and product teams to embed algorithmic capabilities into the enterprise AI platform.
Cross-Functional Collaboration & Strategic Influence
• Partner closely with clinical operations, biostatistics, medical affairs, data management, and regulatory affairs teams to translate business needs into technical solutions, and influence business decisions with data-driven insights.
• Represent the company at industry conferences, academic forums, and client meetings to showcase AI capabilities and enhance industry presence.
Education
• Ph.D. in Computer Science, Artificial Intelligence, Mathematics, Statistics, Bioinformatics, or a related field (exceptional candidates with a Master's degree may be considered).
Experience
• 8+years of experience in machine learning / deep learning, with at least 3+ years in team management or technical leadership roles.
• Proven track record of successful AI modeling in life sciences, biopharma, or clinical trial settings (e.g., patient stratification, enrollment optimization, clinical endpoint prediction) is highly preferred.
Technical Skills
• Expert-level proficiency in Python and mainstream deep learning frameworks (PyTorch /TensorFlow), with hands-on experience in large-scale data processing and distributed training.
• Deep understanding and practical project experience in at least one of the following: LLMs, RAG, multimodal learning, time-series forecasting, or graph neural networks.
• Familiarity with clinical data standards (e.g., CDISC SDTM/ADaM) and regulatory requirements is a plus.
Core Competencies
• Exceptional strategic thinking and business acumen, with the ability to translate complex technical challenges into clear business value propositions.
• Outstanding cross-functional communication and influencing skills, capable of articulating technical strategy and results to executives, clients, and external partners.
• Entrepreneurial mindset and strong results orientation, with the ability to drive innovation in a fast-paced environment.
