Associate Director, Clinical Trial Disclosure

Associate Director, Clinical Trial Disclosure & Transparency Join to apply for the Associate Director, Clinical Trial Disclosure & Transparency role at CSL 1 day ago Be among the first 25 applicants 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 now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. We are seeking 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. This position is to be based onsite (hybrid working) in Maidenhead UK 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 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 Seniority level Mid‑Senior level Employment type Full‑time Job function Science Industries Biotechnology Research and Pharmaceutical Manufacturing #J-18808-Ljbffr