Manages clinical trial case management activities, ensuring compliance with international and national regulations including GxP and pharmacovigilance standards. Oversees safety reporting, vendor performance, and case processing for serious adverse events, while acting as a key liaison for inspections and audits. Provides training, supports database enhancements, and ensures accurate coding and consistency in safety data analysis.
Leads strategic sourcing and evaluation of early-stage (preclinical to Phase 1) external innovation opportunities in the Cardiovascular/Renal therapeutic area. Drives due diligence, shapes partnering strategies, and collaborates with Business Development to execute transactions. Embedded in the Therapeutic Area Leadership Team to align external innovation with portfolio planning.
This role leads the identification, evaluation, and advancement of early-stage external innovation opportunities in the Cardiovascular/Renal therapeutic area. The individual will shape sourcing strategies, co-lead cross-functional assessment of new product opportunities, and drive due diligence and transaction execution in collaboration with Business Development. Embedded in the Therapeutic Area Leadership Team, the position plays a strategic role in portfolio development and external engagement with biotech, academia, and investors.
Oversees the vendor responsible for logging and triaging global adverse event reports in CSL's pharmacovigilance system, ensuring accurate, timely, and compliant case intake. Develops guidance, provides training, and maintains audit readiness for regulatory compliance. Acts as subject matter expert on intake processes across cross-functional projects and procedural documentation.
Leads external innovation sourcing and evaluation in Haematology, identifying preclinical to Phase 1 assets, driving due diligence, and shaping early partnering strategies. Works within the Therapeutic Area Leadership Team to advance high-potential opportunities and collaborates with Business Development to execute deals. Engages with biotech, academia, and investors to build a robust pipeline.
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.
This role involves leading strategic sourcing and evaluation of late-stage external Hematology therapeutic assets, engaging with key opinion leaders, and integrating innovation into portfolio planning. The position requires deep clinical expertise, a proven track record in deal-making, and strong collaboration with cross-functional teams.
Lead the strategic sourcing and evaluation of late-stage therapeutic assets in Immunology, Hematology, or related areas, from Phase 2 through marketed drugs. Drive cross-functional due diligence, engage with key opinion leaders and clinical networks, and shape portfolio strategy through high-impact partnerships and transactions. Operate within a global biotech ecosystem with strong collaboration across R&D, BD, and regulatory functions.
This role involves maintaining and improving CSL's global pharmacovigilance (PV) system, ensuring compliance with GVP and regulatory requirements. Responsibilities include leading investigations, managing deviations, coordinating inspections, and providing PV training across various functions and affiliates.
Lead the development and governance of processes, standards, and SOPs for CSL's global Portfolio Development function, ensuring high-quality clinical program execution. Drive cross-functional process improvement initiatives, change management, and training curriculum development. Collaborate with leadership and stakeholders across R&D to streamline decision-making and enhance operational excellence in a dynamic biotech environment.
This role involves leading CSL's presence in key innovation hubs across Northern Europe and the UK, building strategic relationships with biotech, academia, and investment networks. The Director will source and evaluate opportunities, lead deal teams, and represent CSL at industry events to enhance the company's reputation and deal flow.
Leads CSL's engagement in the Northern Europe and UK biotech innovation ecosystems, building strategic relationships with academia, biotech firms, and investors to identify and drive partnership opportunities. Acts as a senior deal team member, sources external innovation aligned with therapeutic area priorities, and represents CSL at industry events and boards. Requires deep regional network expertise and collaboration with global R&D and business development teams to strengthen the company’s innovation pipeline.
Leads and manages pharmacovigilance safety sciences functions, ensuring compliance with global regulatory standards and overseeing signal detection, safety data analysis, and process optimization. Provides strategic direction for evolving PV legislation and acts as a subject matter expert in audits and inspections. Supports drug development and post-marketing safety reporting while driving data visualization and analytical improvements.
Leads vaccine safety sciences functions, ensuring compliance with pharmacovigilance regulations and global safety standards. Oversees signal detection, safety data analysis, and regulatory documentation while guiding process improvements and cross-functional initiatives. Manages teams and supports regulatory inspections, safety reporting, and the implementation of data visualization tools for enhanced decision-making.
Leads global safety strategy for formulation safety across the product lifecycle, focusing on clinical safety evaluation, signal detection, and risk management. Oversees production of key pharmacovigilance documents and ensures compliance with regulatory standards. Acts as safety representative in cross-functional teams and drives safety specifications and risk mitigation plans.
