Associate Director, Clinical Trial Disclosure & Transparency

The 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 clinical trial disclosure activities including registration, results disclosure and layperson summaries while providing support for transparency activities including anonymization and redaction of commercially confidential information (CCI) as required for business continuity and operational needs. All activities and deliverables must be conducted in alignment with international regulations, CSL policies, industry standards and transparency requirements.Key ResponsibilitiesStrategic Oversight & ComplianceLead enterprise clinical trial disclosure and transparency strategy and advise therapeutic areas and Medical Affairs on global requirements (e.g., FDAAA 801 and the Final Rule, clinicaltrials.gov, CTIS, EU CTR 536/2014, UK Clinical Trials Regulations 2025 (MHRA), EMA Policy 70, Health Canada PRCI)Monitor emerging regulatory and industry trends and influence CSL's disclosure and transparency strategy accordingly. Develop and implement scalable, efficient processes that meet evolving regulatory and industry standardsServe as the primary liaison to public registries (e.g., ClinicalTrials.gov, CTIS, 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 ExecutionSupport transparency activities, including the preparation and delivery of compliant redacted document packages for public release by global Health Authorities, ensuring appropriate business continuity across the disclosure and transparency function.Provide input 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 Privacy and CMO staff to embed disclosure and transparency requirements across the development lifecycleCollaborate closely with other CMO Office team members to ensure effective knowledge sharing, operational continuity and seamless execution of interconnected activitiesRepresent CSL’s disclosure and transparency practices internally and externally, ensuring alignment with global standards and expectationsVendor ManagementSelect, manage, and oversee disclosure and transparency vendors to ensure high-quality deliverables and on-time executionDrive process improvement, innovation and operational excellence in disclosure activitiesOptimize resourcing and technology to support cost-effective deliveryMetrics & MonitoringTrack, analyse and report key metrics to demonstrate compliance, identify risks and drive continuous improvementEducation Requirements10+ years in pharmaceutical/biotech environment with deep knowledge of the drug development processStrong judgement, initiative and ability to operate independently as the global subject matter expert responsible for clinical trial disclosure activitiesDemonstrated ability to independently interpret emerging regulations, assess business impact, identify compliance risks and develop practical, business-focused recommendations.Proven track record in managing global disclosure and transparency deliverables. Demonstrated ability to lead through influence in a matrix environment without direct reporting authorityExcellent written and verbal communication skills, with the ability to translate complex regulatory requirements into clear guidance for stakeholders at all levels.Strong influencing skills and ability to communicate confidently with senior stakeholders, study teams and external vendors.Ability to constructively challenge stakeholders and vendors, provide evidence-based recommendations and maintain professional credibility in complex discussionsStrong critical thinking skills, with the ability to make decisions and recommendations in ambiguous situations, escalating appropriately when required.Strong understanding of ICH-GCP, ICMJE, GDPR and industry best practicesDemonstrated experience providing strategic oversight of vendors, critically reviewing recommendations and maintaining accountability for final decisionsHands on experience with the use and administration of the Trialscope Disclose system (or equivalent)Education Requirement Bachelor’s degree in a scientific, medical, or pharmaceutical discipline requiredThis role requires working in office 3 days per week. #LI-HybridAbout 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 world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at .Our BenefitsFor more information on CSL benefits visit How CSL Supports Your Well-being | CSL.You Belong at CSLAt 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. To learn more about inclusion and belonging visit Opportunity EmployerCSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit .SummaryLocation: EMEA, GB, Berkshire, Maidenhead, CSL Behring; Americas, US-PA, King of Prussia, CSL BehringType: Full time