Associate Director, Clinical Trial Disclosure & Transparency
Join to apply for the Associate Director, Clinical Trial Disclosure & Transparency role at CSL. 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 means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.
We are seeking 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, lay‑person summaries, anonymization and redaction of commercially confidential information (CCI) for clinical trials, in alignment with international regulations, CSL policy and industry standards.
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, Final Rule, clinicaltrials.gov, CTIS, EU CTR 536/2014, EMA Policy 70, Health Canada PRCI).
* Process Development – Develop and implement scalable, efficient processes that meet evolving regulatory and industry standards.
* Liaison to Public Registries – Serve as the primary liaison to 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.
* Timely Communication – 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 compliant redacted document packages for public release by global Health Authorities; advise on transparency obligations and best practices.
* 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.
* Vendor Management – Select, manage, and oversee disclosure and transparency vendors to ensure high‑quality deliverables and on‑time execution.
* Metrics & Monitoring – Track and report key metrics to demonstrate compliance and process performance.
Skills & Experience
* 10+ years in pharmaceutical/biotech environment with deep knowledge of the drug development process.
* Expert in global clinical trial disclosure and transparency regulations, guidelines and registries.
* Proven track record in managing global disclosure 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 operations.
* Hands‑on experience with Trialscope Disclose system or equivalent.
Qualifications & Education
Bachelor’s degree in a scientific, medical, or pharmaceutical discipline required.
Benefits
At CSL we encourage you to make your well‑being a priority. Learn more about how we care at CSL.
About CSL Behring
CSL Behring is a global biotherapeutics leader focused on serving patients’ needs. We discover, develop and deliver innovative therapies for immunology, hematology, cardiovascular, metabolic, respiratory and transplant areas, using plasma fractionation, recombinant protein technology and cell & gene therapy. Our parent company, CSL, employs 32,000 people worldwide.
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