Associate or Associate Director in Maidenhead

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.
• 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).
• Bachelor's degree in a scientific, medical, or pharmaceutical discipline required.

This role requires working in office 3 days per week.