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Associate Director, Clinical Data Transparency and Disclosure (DTD)
Position Summary
The Associate Director, Clinical Data Transparency and Disclosure (DTD), is responsible for leading the global clinical trial transparency strategy and operations, ensuring compliance with all U.S. and international regulations (e.g., FDA/ClinicalTrials.gov, EU CTR, EMA Policy 0070, Health Canada, Japan PMDA, Australia TGA, UK MHRA, WHO standards). This role drives policies, procedures, governance frameworks, and cross-functional execution for disclosure of clinical trial information, results, and patient-level data-sharing, positioning the organization as a leader in data transparency and accountability.
Key Responsibilities
- Define and lead the global clinical data transparency strategy, ensuring alignment with corporate objectives, regulatory requirements, and patient advocacy initiatives.
- Serve as the subject matter expert for ClinicalTrials.gov, EU CTR (CTIS), EudraCT, EMA Policy 0070, Health Canada PRCI, and other global registry requirements.
- Anticipate and assess evolving disclosure and transparency regulations worldwide, driving proactive policy and process updates.
- Represent the company in external industry forums, working groups, and regulatory discussions related to data transparency.
- Establish and maintain the disclosure governance framework, including SOPs, quality standards, and audit readiness practices.
- Oversee development of redaction and anonymization strategies for clinical study documents and patient-level data, ensuring compliance with global privacy laws (e.g., GDPR, HIPAA).
- Provide strategic guidance on plain language summaries and patient-facing transparency deliverables.
- Direct and oversee the registration, results posting, and updates in ClinicalTrials.gov, EU CTR, EudraCT, and other global registries.
- Ensure timely, accurate, and high-quality disclosure deliverables across all global development programs.
- Manage relationships with external vendors, technology platforms, and disclosure service providers.
- Partner with stakeholder functions (e.g., Clinical Development, Clinical Operations, Medical Writing, Biostatistics, Data Management, Pharmacovigilance, Legal, Corporate Communications, Investor Relations, and Regulatory Affairs) to ensure consistency and accuracy of disclosed information.
- Provide training and strategic guidance to relevant teams on global transparency requirements and best practices.
- Foster a culture of accountability, quality, and innovation within the team and across R&D operations.
Qualifications
- Advanced degree in life sciences, public health, or related field (PhD, PharmD, or equivalent strongly preferred).
- 8-10 years of industry experience in regulatory affairs, clinical research, medical writing, or related disciplines, including at least 5 years in clinical trial disclosure and transparency.
- Demonstrated expertise in global disclosure regulations (FDA/ClinicalTrials.gov, EU CTR, EudraCT, EMA Policy 0070, Health Canada PRCI, Japan PMDA, WHO).
- Proven track record of building and leading global teams and/or major transparency initiatives.
- Strong understanding of clinical development, regulatory submissions, and data privacy principles.
- Exceptional leadership, communication, and collaboration skills.
Preferred Skills
- Experience representing an organization in external working groups (e.g., PhRMA, BIO, TransCelerate, CTTI).
- Expertise in data anonymization, redaction technologies, and patient-level data-sharing platforms.
- Experience establishing or maturing a global transparency governance framework.
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