Associate Director, Clinical Trial Disclosure

CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.We are seking an Associate Director Clinical Trial Disclosure and Transparency is a global subject matter expert responsible for ensuring timely, accurate, and compliant clinical trial disclosures across all regions and study types (interventional and observational). This role guides global strategy, drives process excellence, and oversees the delivery of registration, results,andlayperson summaries,anonymization and redaction of commercially confidential information (CCI)for clinical trials, inalignment with international regulations, CSL policy and industry standardsand transparency requirements.Key ResponsibilitiesStrategic Oversight & ComplianceLead enterpriseclinical trialdisclosure andtransparencystrategy and advise therapeutic areas and Medical Affairs on global requirements (e.g., FDAAA 801and the Final Rule,clinicaltrials.gov, CTIS,EU CTR 536 / 2014,EMA Policy 70, Health Canada PRCI)Develop and implement scalable, efficient processes that meet evolving regulatory and industry standardsServe as the primary liaison to public registries (e.g., ClinicalTrials.gov, EudraCT, EU PAS).Disclosure ExecutionOversee and deliver high-quality, compliant disclosures including study registration, protocol amendments, summary results, and lay-person summariesEnsure timely communication of disclosure obligations to clinical teams, affiliates, and stakeholdersSupport CROs and local teams with regional disclosure needsTransparency ExecutionOversee and deliver high-quality, compliant redacted document packages for public release by global Health AuthoritiesAdvise on transparency obligations and best practices, including promotion of Smart Authoring practices, to clinical teams and functionsCross Functional EngagementPartner with Clinical Development, Biostats, Medical Writing, Regulatory,IP, Legal,Data Privacyand CMO staff to embed disclosureand transparencyrequirements across the development lifecycleRepresent CSL’s disclosureand transparencypractices internally and externally, ensuring alignment with global standards and expectationsVendor ManagementSelect, manage, and oversee disclosureand transparencyvendors to ensure high-quality deliverables and on-time executionOptimize resourcing and technology to support cost-effective deliveryMetrics & MonitoringTrack and report key metrics to demonstrate compliance and process performanceSkills and Experience Required10+ years in pharmaceutical / biotech environment with deep knowledge of the drug development processExpert in global clinical trial disclosureand transparencyregulations,andguidelines and registriesProven track record in managing global disclosureand transparencydeliverables and working in cross-functional, matrixed teamsStrong understanding of ICH-GCP, ICMJE,GDPRand industry best practicesExperience with vendor oversight, process improvement, and innovation indisclosure andtransparency operations andtransparencyexecutionHands onexperiencewith the use and administrationof theinTrialscope Disclose system(or equivalent)Qualifications and Education RequiredBachelor’s degree in a scientific, medical, or pharmaceutical discipline requiredOur BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. #J-18808-Ljbffr