Clinical Operations
Senior Manager, Clinical Trial Transparency and Disclosures
Office Location: San Diego, CA
Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
The Senior Manager, 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.
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
Requirements
- Minimum 6 years in the pharmaceutical or biotech industry, with strong experience in clinical development, operations, or regulatory affairs
- Minimum of 3 years in 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
Preferred
- Experience with plain language summary authoring
- 1 year experience managing vendor relationships within an outsourced model
- 1 year managing direct reports
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.