Associate Director / Director, Clinical Trial Transparency and Disclosure at Immunome, Inc.

Bothell, Washington, United States -

Full Time

Start Date

Immediate

Expiry Date

30 May, 26

Salary

214405.0

Posted On

01 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trial Transparency, Disclosure, Data Sharing, Regulatory Compliance, FDAAA 801, ClinicalTrials.gov, EU CTR 536/2014, EMA Policy 70, Health Canada PRCI, Document Redaction, Anonymization, ICH-GCP, GDPR, Vendor Management, TrialScope Disclose, SOP Development

Industry

Biotechnology Research

Description

Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugate therapies. Our pipeline includes varegacestat, a late-clinical stage GSI; IM-1021, a clinical-stage ROR1 ADC; and IM-3050, a FAP-targeted radiotherapy that recently received IND clearance. We are also advancing a broad portfolio of early stage ADCs pursuing undisclosed solid tumor targets. 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. Washington State Pay Range $186,513—$214,405 USD E/E/O Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. E-Verify Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish).

Responsibilities

This role leads the global clinical trial disclosure and transparency strategy, ensuring compliance with international regulations and company policies across registration, results disclosure, and public data release. The position oversees operational execution, manages cross-functional integration of transparency principles, and develops necessary systems and vendor oversight.