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 Responsibilities
Strategic Oversight & Compliance
Lead 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 standards
Serve as the primary liaison to public registries (e.g., ClinicalTrials.gov, EudraCT, EU PAS).
Disclosure Execution
Oversee and deliver high-quality, compliant disclosures including study registration, protocol amendments, summary results, and lay-person summaries
Ensure timely communication of disclosure obligations to clinical teams, affiliates, and stakeholders
Support CROs and local teams with regional disclosure needs
Transparency Execution
Oversee and deliver high-quality, compliant redacted document packages for public release by global Health Authorities
Advise on transparency obligations and best practices, including promotion of Smart Authoring practices, to clinical teams and functions
Cross Functional Engagement
Partner with Clinical Development, Biostats, Medical Writing, Regulatory,IP, Legal,Data Privacyand CMO staff to embed disclosureand transparencyrequirements across the development lifecycle
Represent CSL’s disclosureand transparencypractices internally and externally, ensuring alignment with global standards and expectations
Vendor Management
Select, manage, and oversee disclosureand transparencyvendors to ensure high-quality deliverables and on-time execution
Optimize resourcing and technology to support cost-effective delivery
Metrics & Monitoring
Track and report key metrics to demonstrate compliance and process performance
Skills and Experience Required
10+ years in pharmaceutical / biotech environment with deep knowledge of the drug development process
Expert in global clinical trial disclosureand transparencyregulations,andguidelines and registries
Proven track record in managing global disclosureand transparencydeliverables and working in cross-functional, matrixed teams
Strong understanding of ICH-GCP, ICMJE,GDPRand industry best practices
Experience with vendor oversight, process improvement, and innovation indisclosure andtransparency operations andtransparencyexecution
Hands onexperiencewith the use and administrationof theinTrialscope Disclose system(or equivalent)
Qualifications and Education Required
Bachelor’s degree in a scientific, medical, or pharmaceutical discipline required
Our Benefits
We encourage you to make your well-being a priority. It’s important and so are you.
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