Key Responsibilities
* Lead enterprise clinical trial disclosure and transparency strategy, advising therapeutic areas and Medical Affairs on global regulatory requirements (e.g., FDAAA 801, CTIS EU CTR 536/2014, EMA Policy 70, Health Canada PRCI).
* Develop and implement scalable, efficient processes that meet evolving regulatory and industry standards for study registration, protocol amendments, summary results, and lay‑person summaries.
>Serve as the primary liaison to public registries (EudraCT, EU PAS, etc.) and oversee 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, and support CROs and local teams with regional disclosure needs.
* Oversee and deliver high‑quality compliant redacted document packages for public release by global Health Authorities and advise on transparency obligations and best practices, including promotion of Smart Authoring practices.
* 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 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, and track and report key metrics to demonstrate compliance and process performance.
Skills and Experience Required
* 10+ years in a 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 and transparency deliverables and working in cross‑functional matrixed teams.
* Strong understanding of ICH‑GCP, ICMJ, EGDPR, PR, and industry best practices.
* Experience with vendor oversight, process improvement, innovation in disclosure and transparency operations and 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.
Benefits
We encourage you to make your well‑being a priority. Its important and so are you. Learn more about how we care at CSL.
About CSL Behring
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, 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.
Inclusion and Belonging
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 about Inclusion and Belonging at CSL.
Do Work That Matters at CSL Behring!
Associate Director Clinical Trial Disclosure Transparency • Maidenhead, England, UK
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