Associate Director, Clinical Trial Disclosure, Transparency

• 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).


• 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


• 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


• 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


• 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


• Track, analyse and report key metrics to demonstrate compliance, identify risks and drive continuous improvement

Requirements

• 10+ years in pharmaceutical/biotech environment with deep knowledge of the drug development process


• Strong judgement, initiative and ability to operate independently as the global subject matter expert responsible for clinical trial disclosure activities


• Demonstrated ability to independently interpret emerging regulations, assess business impact, identify compliance risks and develop practical, business‑focused recommendations.


• Proven track record in managing global disclosure and transparency deliverables.


• Demonstrated ability to lead through influence in a matrix environment without direct reporting authority


• Excellent written and verbal communication skills, with the ability to translate complex regulatory requirements into clear guidance for stakeholders at all levels.


• Strong influencing skills and ability to communicate confidently with senior stakeholders, study teams and external vendors.


• Ability to constructively challenge stakeholders and vendors, provide evidence-based recommendations and maintain professional credibility in complex discussions


• Strong critical thinking skills, with the ability to make decisions and recommendations in ambiguous situations, escalating appropriately when required.


• Strong understanding of ICH‑GCP, ICMJE, GDPR and industry best practices


• Demonstrated experience providing strategic oversight of vendors, critically reviewing recommendations and maintaining accountability for final decisions


• Hands on experience with the use and administration of the Trialscope Disclose system (or equivalent)

Core Competencies

Expertise in clinical trial disclosure and transparency, with a strong understanding of regulatory requirements such as FDAAA 801, ICH‑GCP, and GDPR. Proven ability to lead cross‑functional teams and manage vendor relationships to ensure compliance and operational excellence.

Highest-signal resume keywords

• Clinical Trial Disclosure Strategy


• Regulatory Compliance Expertise


• Vendor Management


• Strong Communication Skills


• Critical Thinking

ATS Optimization Keywords

Hard Skills

• Drug Development Process


• Regulatory Interpretation


• Compliance Risk Assessment


• Global Disclosure Management


• Process Improvement

Soft Skills

• Strong Judgement


• Initiative


• Influencing Skills


• Ability to Challenge Stakeholders


• Decision-Making in Ambiguous Situations

Industry Keywords

• Pharmaceutical


• Biotech


• ICH‑GCP


• ICMJE


• GDPR

Tools & Technologies

• Trialscope Disclose System


• ClinicalTrials.gov


• CTIS


• EU PAS