Lead the clinical development strategy for antibody-drug conjugates (ADCs) across multiple tumor types, from early-phase through registrational trials and market launch. Drive integrated clinical and translational research, represent the asset at key governance forums, and shape portfolio-level decision-making in oncology. Work across global cross-functional teams to advance innovative therapies within a matrixed biopharma environment.
Leads the clinical development strategy for antibody-drug conjugates (ADCs) in oncology, spanning early- to late-phase trials across multiple tumor types. Responsible for end-to-end asset development, including regulatory approval and launch readiness, with a focus on scientific rigor, innovation in trial design, and cross-functional collaboration. Engages with global health authorities, governance bodies, and external experts to shape clinical and translational strategies.
This role involves leading and executing phase-appropriate bioanalytical strategies for immunogenicity and ligand binding assays (LBA) within Moderna’s mRNA-LNP therapeutic pipeline. The Principal Scientist will oversee assay development, validation, and sample analysis, ensuring regulatory compliance and scientific rigor across clinical programs. The position emphasizes collaboration with cross-functional teams, integration of emerging technologies including AI-enabled tools, and contribution to regulatory submissions and data interpretation in a GcLP-compliant environment.
The Central Monitor (CM) is responsible for overseeing clinical trials through centralized monitoring, ensuring data quality, identifying risks, and enhancing trial oversight. They collaborate with cross-functional teams, configure monitoring technology, and communicate findings to stakeholders.
The Central Monitor (CM) is responsible for overseeing clinical trials through centralized monitoring, ensuring data quality, identifying risks, and collaborating with cross-functional teams. Key responsibilities include executing monitoring strategies, conducting data surveillance, and supporting risk management processes.
Develops and validates ligand-binding and cell-based assays to support clinical programs for mRNA medicines. Performs pharmacodynamic and immunogenicity testing in compliance with GcLP, using platforms like Thermo Watson LIMS. Contributes to assay development, reagent management, and regulatory documentation in a fast-paced, innovative lab environment.
The Quality Systems Manager will lead the Quality Management System (QMS) and compliance function within an aseptic compounding unit, ensuring robust processes, strong compliance, and continuous improvement. Key responsibilities include managing document control, monitoring quality KPIs, overseeing CAPAs, and leading internal and external audits.
This role involves testing raw materials, in-process, stability, and finished product samples using approved analytical methods in a busy GMP laboratory. You will work closely with Production, QA, and Technical teams, supporting investigations, method validation, and continuous improvement.
The Quality Manager will lead the implementation and maintenance of an ISO 13485 Quality Management System, working closely with the science and engineering teams to ensure compliance and continuous improvement. This hands-on role involves document control, internal audits, and supplier management, with a focus on building a strong quality culture in a growing start-up.
Leads global pharmacovigilance and safety strategy for gene therapy products, overseeing signal management, risk assessment, and benefit-risk profiling across investigational and marketed phases. Provides medical oversight for clinical trials, including safety data review, SAE evaluation, and regulatory submissions. Collaborates cross-functionally to ensure compliance with global safety regulations and supports health authority interactions on product safety matters.
This role involves leading the development and validation of bioanalytical methods, managing a laboratory team, and ensuring compliance with GLP and VICH guidelines. Responsibilities include method optimization, troubleshooting, staff training, and regulatory support.
This role involves leading the Clinical Method Development and Validation team, overseeing bioanalytical method delivery, and ensuring compliance with GLP standards. Responsibilities include optimizing analytical systems, managing a team, and driving continuous improvement in a cutting-edge research environment.
This role involves leading the Quality Systems and Compliance function, ensuring GMP and GDP compliance, managing quality records, and overseeing internal and external audits. You will also manage a team of three, drive continuous improvement, and champion risk management.
This role involves deploying and integrating generative AI models into pharmaceutical and biotech customers' scientific workflows. The engineer will lead end-to-end technical deployments, build production-grade API integrations and data pipelines, and act as a technical liaison between customers and internal research teams. A strong background in ML infrastructure, cloud platforms, and customer-facing delivery in life sciences is essential.
This role involves leading and managing a team of scientists in the development of inhalation and respiratory drug products. Responsibilities include providing technical expertise, mentoring team members, and ensuring project success and regulatory compliance.
