Associate Director, Clinical Trial Disclosure & Transparency

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 disclosureandlayperson 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 inalignment with international regulations, CSL policies, industry standardsand transparency requirements.

Key Responsibilities

Strategic Oversight & Compliance

Lead enterpriseclinical trialdisclosure andtransparencystrategy and advise therapeutic areas and Medical Affairs on global requirements (e.g., FDAAA 801and 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 Privacyand CMO staff to embed disclosureand transparencyrequirements 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 CSLs disclosureand transparencypractices internally and externally, ensuring alignment with global standards and expectations

Vendor Management

Select, manage, and oversee disclosureand transparencyvendors to ensure high-quality deliverables and on-time execution

Drive process improvement, innovation and operational excellence indisclosure 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

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• 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 disclosureactivities
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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 disclosureand transparencydeliverables. 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,GDPRand 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 onexperiencewith the use and administrationof theTrialscope Disclose system(or equivalent)
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Education Requirement

Bachelors degree in a scientific, medical, or pharmaceutical discipline required

This role requires working in office 3 days per week. #LI-Hybrid

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