Associate Director, Clinical Trial Disclosure

CSLs R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration were 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 resultsandlayperson summariesanonymization 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 CTISEU CTR 536/2014EMA 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. 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 RegulatoryIP LegalData Privacyand CMO staff to embed disclosureand transparencyrequirements across the development lifecycleRepresent CSLs 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 transparencyregulationsandguidelines and registriesProven track record in managing global disclosureand transparencydeliverables and working in cross-functional matrixed teamsStrong understanding of ICH-GCP ICMJEGDPRand 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 RequiredBachelors degree in a scientific medical or pharmaceutical discipline requiredOur BenefitsWe encourage you to make your well-being a priority. Its important and so are you. Learn more about how we care at CSL.About CSL BehringCSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients needs by using the latest technologies we discover develop and deliver innovative therapies for people living with conditions in the immunology hematology cardiovascular and metabolic respiratory and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation recombinant protein technology and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.CSL Behring operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.We want CSL to reflect the world around usAt CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSLDo work that matters at CSL BehringRequired Experience:Director Key Skills Program assessment,FDA Regulations,Manufacturing & Controls,Program Evaluation,budget forecast,Research Experience,Operations Management,Research & Development,Strategic Planning,Contract Management,Leadership Experience,negotiation Employment Type : Full-Time Experience: years Vacancy: 1