Associate Director / Director, Clinical Trial Transparency and Disclosure

Position Overview

The Associate Director / Director, Clinical Trial Transparency and Disclosure serves as the company’s subject matter expert on global clinical trial transparency, disclosure, and data sharing. This role is responsible for ensuring timely, accurate, and compliant registration, results disclosure, and public release of clinical trial information in accordance with international regulations, company policies, and industry standards.

As both a strategic advisor and operational leader, this position will define and implement the company’s global disclosure and transparency framework, supporting compliance and fostering trust through responsible data sharing. You will work collaboratively across the organization to promote data integrity, patient engagement, and responsible information sharing. Candidates should possess a strong understanding of registration, disclosure, and data sharing requirements and when they are applicable at all stages of the drug development process.

Responsibilities

Strategic Oversight and Compliance

• Lead the global clinical trial disclosure and transparency strategy, ensuring alignment with regulatory requirements (e.g., FDAAA 801 and the Final Rule, ClinicalTrials.gov, EU CTR 536/2014, EMA Policy 70, Health Canada PRCI).
• Serve as an advisor to clinical, medical, CMC, and regulatory functions on disclosure requirements and transparency best practices.
• Monitor and interpret evolving global regulations, industry trends, and emerging technologies to ensure continuous compliance and process readiness.
• Partner cross-functionally with Clinical Development, Medical Writing, Regulatory Affairs, Biostatistics, Data Privacy, Legal, and Corporate Communications to integrate transparency principles throughout the drug development lifecycle.

Disclosure Operations

• Oversee and execute the accurate and timely registration of clinical trials and posting of results, protocol amendments, and layperson summaries.
• Ensure quality, consistency, and compliance in all public-facing trial data and documentation.
• Oversee anonymization and redaction of documents (e.g., CSRs, protocols, synopses) for public disclosure in accordance with global data protection and confidentiality requirements.
• Support inspection readiness and respond to audit requests related to transparency and disclosure activities.

Transparency and Data Sharing

• Develop, manage and maintain systems and repositories supporting trial disclosure, transparency tracking, and data sharing requests.
• Guide the preparation and review of redacted document packages for health authority publication (e.g., EMA Policy 70, Health Canada PRCI).
• Support the company’s data sharing strategy, including evaluation and fulfillment of external data requests.

Process and Vendor Management

• Identify and implement opportunities for process and system optimization, leveraging digital tools to enhance efficiency and compliance.
• Select, manage, and oversee external vendors or contractors supporting disclosure and transparency deliverables.
• Establish performance metrics to monitor compliance, timeliness, and quality of deliverables

Leadership and Collaboration

• Represent the company externally in relevant industry working groups and forums related to clinical trial transparency and disclosure.
• Provide mentorship, oversight, and training to junior staff or contractors.
• Contribute to the development and maintenance of SOPs, work instructions, and guidance documents for disclosure and transparency operations.

Qualifications

• Bachelor’s degree in a scientific, medical, or pharmaceutical discipline; advanced degree preferred.
• A minimum of 6 to 10 years of experience in the pharmaceutical or biotechnology industry, including significant experience in clinical trial disclosure, transparency, or related regulatory functions.

Knowledge and Skills

• In-depth understanding of global disclosure requirements and registries (ClinicalTrials.gov, EU CTR, EudraCT, CTIS. etc.).
• Proven experience with document redaction and anonymization for public disclosure.
• Strong knowledge of ICH-GCP, ICMJE, GDPR, and relevant regulatory frameworks.
• Demonstrated success in managing complex cross-functional projects and working in matrixed environments.
• Experience with vendor management and familiarity with disclosure systems such as TrialScope Disclose (or equivalent).
• Excellent communication, leadership, and interpersonal skills.
• Meticulous attention to detail and ability to manage multiple priorities in a fast-paced environment.