Director, Clinical Trial Transparency and Disclosures

Arrowhead Pharmaceuticals • San Diego, CA

6d • $200,000 - $230,000

About The Position

The Director of Clinical Trial Transparency and Disclosures (CTTD) is responsible for driving Arrowhead’s global transparency strategy, overseeing the planning and execution of clinical trial disclosure activities, and ensuring compliance with international regulations and internal policies.

Requirements

• Minimum 10 years in the pharmaceutical or biotech industry, with strong experience in clinical development, operations, or regulatory affairs
• Minimum of 5 years in a leadership role managing transparency or disclosure functions
• Advance knowledge of ICH-GCP
• Advance knowledge of global clinical trial transparency and disclosure requirements, including clinical trial registration, results posting, plain language summaries, redaction policies, and regulatory timelines
• 4-year college degree

Nice To Haves

• Experience with plain language summary authoring
• 1 year experience managing vendor relationships within an outsourced model
• 1 year managing direct reports

Responsibilities

• Lead the CTTD team, driving strategic vision, team performance, and operational excellence
• Set department goals aligned with Arrowhead’s clinical development and corporate transparency strategy
• Contribute to long-term planning, budgeting, and performance measurements for the CTTD team
• Ensure compliance with global transparency regulations (e.g., FDAA801, EU CTR, Clinicaltrials.gov, EU CTIS, Health Canada, WHO)
• Serve as the senior point of contact for audit readiness and inspection response related to disclosure activities
• Maintain oversight of disclosure timelines, deliverables, and risk mitigation across the portfolio
• Own and continuously improve all CTTD procedures, templates, and controlled documents
• Leverage technological tools to enhance data quality, operational efficiency, and end-to-end disclosure execution
• Provide coaching, feedback, and mentorship to support junior CTTD development and retention
• Lead all CTTD vendor partnerships, including contract negotiation, compliance monitoring, performance management, and continuous improvement
• Ensure department remains within budget, including planning, forecasting, and vendor-related spend
• Partner with stakeholders across Clinical Operations, Regulatory Affairs, Legal, and Medical Writing to integrate transparency efforts into the broader clinical strategy
• Represent CTTD in cross-functional initiatives, governance forums, and senior leadership discussions
• Monitor and interpret evolving global regulatory trends and industry best practices
• Anticipate regulatory changes and guide internal process updates to maintain compliance and leadership in transparency practices

Benefits

• Arrowhead provides competitive salaries and an excellent benefit package.

What This Job Offers

• Job Type: Full-time
• Career Level: Director