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Csl

Associate Director, Clinical Trial Disclosure & Transparency

Location2 Locations
Work modehybrid
Typefull-time
DepartmentClinical Development
Company size10,000+ people
First seen1w ago
Last seen2d ago
About the role
The 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 clinical trial disclosure activities including registration, results disclosure and layperson summaries while providing support for transparency activities including anonymization and redaction of commercially confidential information (CCI) as required for business continuity and operational needs. All activities and deliverables must be conducted in alignment with international regulations, CSL policies, 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, UK Clinical Trials Regulations 2025 (MHRA), EMA Policy 70, Health Canada PRCI)
Monitor emerging regulatory and industry trends and influence CSL’s disclosure and transparency strategy accordingly. 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, CTIS, 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
Support transparency activities, including the preparation and delivery of compliant redacted document packages for public release by global Health Authorities, ensuring appropriate business continuity across the disclosure and transparency function.
Provide input 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
Collaborate closely with other CMO Office team members to ensure effective knowledge sharing, operational continuity and seamless execution of interconnected activities
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
Drive process improvement, innovation and operational excellence in disclosure activities
Optimize resourcing and technology to support cost-effective delivery
Metrics & Monitoring
Track, analyse and report key metrics to demonstrate compliance, identify risks and drive continuous improvement
Education Requirements
•
10+ years in pharmaceutical/biotech environment with deep knowledge of the drug development process
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Strong judgement, initiative and ability to operate independently as the global subject matter expert responsible for clinical trial disclosure activities
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Demonstrated ability to independently interpret emerging regulations, assess business impact, identify compliance risks and develop practical, business-focused recommendations.
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Proven track record in managing global disclosure and transparency deliverables. Demonstrated ability to lead through influence in a matrix environment without direct reporting authority
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Excellent written and verbal communication skills, with the ability to translate complex regulatory requirements into clear guidance for stakeholders at all levels.
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Strong influencing skills and ability to communicate confidently with senior stakeholders, study teams and external vendors.
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Ability to constructively challenge stakeholders and vendors, provide evidence-based recommendations and maintain professional credibility in complex discussions
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Strong critical thinking skills, with the ability to make decisions and recommendations in ambiguous situations, escalating appropriately when required.
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Strong understanding of ICH-GCP, ICMJE, GDPR and industry best practices
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Demonstrated experience providing strategic oversight of vendors, critically reviewing recommendations and maintaining accountability for final decisions
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Hands on experience with the use and administration of the Trialscope Disclose system (or equivalent)
Education Requirement
Bachelor’s degree in a scientific, medical, or pharmaceutical discipline required
This role requires working in office 3 days per week. #LI-Hybrid
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 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.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
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.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
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