Develops and executes global and regional regulatory strategies for oncology assets, ensuring optimal labelling and approvals while maintaining compliance. Works with the Global Regulatory Lead and cross-functional teams to shape development plans and support authority interactions and submissions across multiple regions.
Develops and executes global and regional regulatory strategies for oncology assets, ensuring optimal labelling and approvals while maintaining compliance. Works with the Global Regulatory Lead and cross-functional teams to shape development plans and support authority interactions and submissions across multiple regions.
First Technical Program Manager for the Drug Design and Medical Research function, supporting small molecule discovery programs in Cambridge and integrating with the London office. Responsibilities span program planning, timeline monitoring, risk reporting, budget forecasting and spend tracking, CRO and partner liaison, and embedding operational processes across teams.
Leads strategic sourcing and evaluation of late-stage external clinical assets in Immunology, from Phase 2 through marketed drugs, as the senior S&E leader within the Therapy Area Leadership Team. Drives proactive sourcing, cross-functional due diligence, and KOL engagement, partnering with BD to advance high-priority opportunities through negotiation and deal close.
Owns safety assessment strategy for drug discovery projects from inception to regulatory submission, working with small molecule and biologics platforms. Designs screening cascades, authors IND packages, and manages CRO relationships for outsourced wet-lab work. Also guides development of an AI predictive toxicology platform with ML researchers.
Monitors oncology clinical trial sites through selection, initiation, monitoring and close-out visits, ensuring GCP and ICH compliance. Tracks recruitment, regulatory submissions, CRF completion and data queries, and maintains Trial Master File documentation. Works within a biotech-focused team supporting emerging biopharma sponsors.
Shape global CMC regulatory strategy for an innovative mRNA medicines portfolio, driving international submissions and health authority interactions. Prepare and review CMC sections of regulatory filings, advise Manufacturing and Quality teams, and oversee multiple development programs. An individual contributor role with global reach, working alongside teams using digital and Generative AI tools.
Supports late-stage oncology clinical development in collaboration with a Clinical Scientist Program Lead, covering study start-up, execution, close-out, data analysis and regulatory filings. Involves drafting protocols and CRFs, reviewing data and contributing to submissions, with a focus on CAR T-cell and multiple myeloma programmes.
Provides statistical consulting and strategic advice on optimal study designs and analyses across drug, device, and diagnostic clinical development, including preparation for regulatory authority interactions. Serves as a leader in innovative study designs for client accounts and supports new business through proposals, bids, and client presentations, representing clients at key regulatory meetings.
Supervises a team of laboratory staff in a central laboratory services environment, setting day-to-day operational activities and ensuring effective delivery. Oversees hiring, training, performance management, safety compliance, CAPA and quality incident resolution, and reviews laboratory metrics to drive process improvement. Requires immunology-based clinical laboratory or clinical trials experience and proficiency with LIMS.
Leads a team of medical writers and oversees strategic planning and drafting of complex regulatory submissions at the therapeutic area or portfolio level. Acts as subject matter expert, driving document strategy with cross-functional teams across Regulatory Affairs, Clinical Research and Clinical Data Science, plus process improvement and training initiatives.
Leads scientific safety assessments for assigned medicinal products, partnering with Medical Safety Officers to prepare analyses and evaluations for regulatory compliance. Supports Safety Management Teams, chairs proactive safety data reviews, and acts as product point of contact, with oversight of deliverables from other team members. Hybrid role requiring three days a week on site.
Accountable to the Global Clinical Head for an indication-aligned cluster of late-phase Respiratory and Immunology studies, supervising Global Development Medical Directors and Scientist Directors. Leads cross-functional design, conduct, monitoring and data interpretation, represents the program at health authority interactions, and co-leads publication strategy.
Monitors investigator sites using a risk-based approach, conducting remote and on-site visits to assess protocol and regulatory compliance, performing SDR, SDV and CRF review, and documenting findings in reports. Acts as a site processes specialist ensuring trials follow ICH-GCP, applicable regulations and SOPs, while developing collaborative relationships with investigational sites and supporting audit readiness.
Leads clinical strategy and execution for one or more GI oncology indications of a given asset, owning the Target Product Profile and disease area strategy. Manages a team of physicians and scientists designing, running, analysing and interpreting all clinical studies, and acts as internal and external clinical authority for regulatory interactions and business development. Requires deep therapeutic expertise and 8+ years of drug development experience, with international and domestic travel.
