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, and layperson summaries, anonymization and redaction of commercially confidential information (CCI) for clinical trials, in alignment with international regulations, CSL policy and industry standards and transparency requirements.
Key Responsibilities
Strategic Oversight & Compliance
Lead 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, 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 Privacy and CMO staff to embed disclosure and transparency requirements across the development lifecycle
Represent CSL’s disclosure and transparency practices internally and externally, ensuring alignment with global standards and expectations
Vendor Management
Select, manage, and oversee disclosure and transparency vendors 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 disclosure and transparency regulations, and guidelines and registries
Proven track record in managing global disclosure and transparency deliverables and working in cross-functional, matrixed teams
Strong understanding of ICH-GCP, ICMJE, GDPR and industry best practices
Experience with vendor oversight, process improvement, and innovation in disclosure and transparency operations and transparency execution
Hands on experience with the use and administration of the in Trialscope Disclose system (or equivalent)
Qualifications and Education Required
Bachelor’s degree in a scientific, medical, or pharmaceutical discipline required
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
CSL 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.
At 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 | CSL