Associate Director, Clinical Trial Disclosure, Transparency

CSL

Associate Director managing clinical trial disclosures for CSL Behring. Overseeing compliance and transparency activities across global pharmaceutical operations.

Posted 7/31/2026full-timeMaidenhead • Pennsylvania • 🇺🇸 United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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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 StrategyRegulatory Compliance ExpertiseVendor ManagementStrong Communication SkillsCritical Thinking

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Drug Development ProcessRegulatory InterpretationCompliance Risk AssessmentGlobal Disclosure ManagementProcess Improvement

Soft Skills

Strong JudgementInitiativeInfluencing SkillsAbility to Challenge StakeholdersDecision-Making in Ambiguous Situations

Tools & Technologies

Trialscope Disclose SystemClinicalTrials.govCTISEU PAS

Industry Keywords

PharmaceuticalBiotechICH-GCPICMJEGDPR

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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)

Benefits

Comp & perks

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL