Leads strategic sourcing and evaluation of early-stage innovation in haematology, from preclinical to Phase 1 assets. Drives due diligence, shapes partnering strategies, and executes transactions in collaboration with Business Development. Embedded in the Therapeutic Area Leadership Team to influence portfolio planning and external innovation priorities.
Lead the technical development and implementation of a new labeling and secondary packaging operation at Moderna's Harwell site, ensuring compliance with GxP and safety standards. Establish maintenance strategies, lead capital projects, and drive continuous improvement using engineering excellence principles. Work closely with global teams and support digital integration in a high-growth biotech environment.
This role involves leading CMC regulatory strategies and submissions for international markets, with a focus on mRNA-based products across vaccines, oncology, and rare diseases. The individual will guide global regulatory compliance, interact with health authorities, and support manufacturing and quality teams through regulatory interpretation and change control. It requires deep expertise in CTD-format filings and a proactive approach to managing multi-therapeutic regulatory programs in a fast-paced environment.
Lead the development and execution of nonclinical safety strategies for small molecule drug candidates in oncology and non-oncology programs, integrating AI-driven predictive models with traditional toxicology. Build and scale the nonclinical safety function within an AI-first drug discovery environment, ensuring high-quality data feedback to refine computational models. Collaborate across preclinical, clinical, and regulatory teams to advance compounds through IND and NDA/MAA-enabling studies.
This role leads the planning and execution of translational medicine strategies for GSK’s antibody-drug conjugate (ADC) oncology portfolio. The Director will integrate biomarker and diagnostic development with clinical programs, manage cross-functional teams, and ensure operational readiness for key milestones. They will provide strategic project management oversight, drive governance reporting, and support regulatory compliance across global oncology projects.
This role involves leading pharmacovigilance and risk management strategy for GSK’s global pharmaceutical assets, with a focus on patient safety across clinical development and post-marketing phases. The Medical Director will lead safety governance, drive signal detection and risk mitigation, and represent GSK in regulatory discussions. It requires deep expertise in drug safety, cross-functional leadership in a matrix environment, and strategic input into global safety operations.
This role leads global regulatory CMC strategy for mRNA-based medicines, developing and implementing regulatory plans for international submissions. The individual will guide CMC documentation, interact with health authorities, and provide strategic input across product development stages, ensuring compliance with EU and global regulations. The position plays a key part in advancing Moderna’s pipeline of transformative therapeutics across vaccines, oncology, and rare diseases.
This role involves leading CMC regulatory strategy for global mRNA product development, preparing and reviewing regulatory submissions, and guiding cross-functional teams on compliance and agency interactions. The position requires deep expertise in biologics CMC regulations, particularly in EU and ROW markets, and plays a key part in shaping regulatory pathways across vaccines, oncology, and rare diseases. Based at the Harwell site, it emphasizes in-office collaboration within a multidisciplinary team.
This role involves leading scientific strategy and execution for immunogenicity and ligand binding assays (LBA) in support of Moderna’s mRNA-LNP therapeutic programs. The Principal Scientist will oversee regulated bioanalytical activities including assay development, validation, and sample analysis, ensuring compliance with GcLP, GLP, and GCP standards. The position plays a key role in clinical development by generating high-quality data to inform regulatory submissions and advance innovative medicines, with opportunities to engage in AI-enabled and digital analytical approaches.
Lead the technical development and implementation of a new labeling and secondary packaging operation at Moderna’s Harwell site, from initial design through commissioning and validation. Establish maintenance strategies, ensure GMP compliance, and drive continuous improvement using engineering excellence principles and digital tools. Build and lead a high-performing engineering team to support long-term operational success in a regulated biotech environment.
A senior scientific leadership role focused on pharmacovigilance and safety risk management for GSK's global pharmaceutical assets. The role involves leading safety strategy, evaluating clinical data, and ensuring regulatory compliance across development and post-marketing stages. It requires deep expertise in drug safety, cross-functional leadership, and communication with regulatory authorities.
