20 jobs for “CSL”
Oversees vendor delivery of medical evaluations for individual case safety reports, applying medical and scientific judgment on causality, expectedness and seriousness. Trains Medical Evaluators, sets assessment frameworks and drives process improvements across Global Safety and Pharmacovigilance. Requires deep pharmacovigilance knowledge and cross-functional stakeholder work.
CSL · 10001+ people · Public
Leads safety surveillance and signal detection across a product's lifecycle, reviewing clinical and post-marketing data and contributing to aggregate safety reports and risk management plans. Partners with Global Safety Leads and cross-functional teams, mentors junior scientists, and supports regulatory responses.
Microsoft Excel
Leads the full scope of statistical contribution to a clinical development programme, defining statistical strategy and methodologies for trial design, analysis and regulatory submissions. Represents Biostatistics in interactions with authorities such as FDA, EMA and PMDA, and manages outsourcing or internal statistical programmers. Two positions support multiple therapeutic areas.
SAS · R
Leads the full statistical contribution to a clinical development programme, defining statistical strategy for trial design, analysis and regulatory submissions, and representing Biostatistics in interactions with the FDA, EMA and PMDA. Also manages outsourcing to CROs and internal statistical programmers, and supports departmental improvement initiatives.
SAS · R
Owns quality oversight of external CROs, laboratories and test facilities supporting nonclinical and GLP activities, running the full vendor lifecycle from due diligence and quality agreements to risk-based monitoring, CAPAs and governance forums. Coordinates inspection readiness and audit support, ensures compliance with GLP/GCP/GMP, OECD GLP, 21 CFR Part 58 and ALCOA+ data integrity, and leads vendor risk assessments such as FMEA and risk registers.
OECD GLP · 21 CFR Part 58 · Annex 11 +3
Leads strategic sourcing and evaluation of external innovation opportunities in Haematology, identifying preclinical to Phase 1 assets and shaping early partnering strategies. Sits on the Therapeutic Area Leadership Team, co-leads New Product Opportunity reviews, drives cross-functional due diligence and works with Business Development on deal execution. Hybrid, three days a week at an R&D hub site.
Leads strategic sourcing and evaluation of external innovation opportunities in Haematology, identifying preclinical to Phase 1 assets and shaping early partnering strategies. Sits on the Therapeutic Area Leadership Team, co-leads New Product Opportunity reviews, drives cross-functional due diligence, and works with Business Development on deal execution. Hybrid, three days a week at an R&D hub site.
CSL · 10001+ people · Public
Leads a cross-functional Clinical Development Team as the lead scientific expert, owning the clinical strategy, plan and medical monitoring for immunoglobulin programs. Accountable for clinical content of regulatory submissions and study documents, and serves as medical monitor across trials in a matrixed environment.
CSL · 10001+ people · Public
Leads the cross-functional Clinical Development Team as lead scientific expert, owning the Clinical Development Plan and integrating internal and external contributions into program strategy. Serves as medical monitor, authors key regulatory and study documents, and presents to safety and review committees.
Leads a global team of development and regulatory project managers overseeing complex R&D programs across a therapeutic area, including new product development and life cycle management. Drives portfolio planning, risk assessment, and cross-functional alignment as part of the Portfolio & Operations Excellence leadership team, with hands-on coaching and process improvement.
Microsoft Project · Planview · Smartsheet +1
Owns quality oversight of external CROs, laboratories and test facilities supporting nonclinical and GLP activities, running the vendor lifecycle from due diligence and quality agreements to risk-based monitoring, CAPAs and inspection readiness. Ensures adherence to GLP/GCP/GMP, OECD GLP, 21 CFR Part 58 and data integrity (ALCOA+), partnering with Nonclinical Development, Procurement, Legal and IT.
OECD GLP · 21 CFR Part 58 · Annex 11 +3
Provides medical and scientific expertise on clinical safety across the full product lifecycle, with emphasis on evaluating safety data during clinical development and post-approval. Chairs the Safety Management Team, oversees signal detection, aggregate reports (DSURs, PSURs, RMPs) and regulatory responses, and sets safety strategy for global cross-functional development and post-marketing teams.
DSUR · PSUR · RMP +2
Provides medical and scientific expertise on clinical safety across a product's lifecycle, with emphasis on signal detection, risk management and regulatory submissions. Chairs the Safety Management Team, oversees aggregate reports such as DSURs, PSURs and RMPs, and acts as the safety representative in cross-functional development and post-marketing teams.
DSUR · PSUR · RMP +3
Acts as case management subject matter expert for assigned clinical trials, overseeing safety reporting plans, vendor performance and ICSR compliance. Leads pharmacovigilance processes, supports GxP inspections and audits, and provides study-specific training to vendors and internal teams. Requires deep PV and regulatory knowledge in a multinational pharmaceutical setting.
Drug Safety Database
Leads the Operational Excellence function at a major influenza vaccine manufacturing site, deploying Lean, Six Sigma and the CSL Operating System to translate strategy into operational priorities and financial benefits. Owns the site management system, structured problem solving and continuous improvement, coaching senior leaders and leading the OE team. Reports to the Manufacturing Site Lead and sits on the Site Leadership Team.
CSL Operating System
