Clinical Operations Manager (15 month contract)

Position Overview

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company developing medicines that treat intractable diseases by silencing the genes that cause them. Their innovative RNAi-based therapeutics target conditions across diverse therapeutic areas, including diseases outside the liver.

The Clinical Operations Manager (COM) will manage multiple Phase 1-4 clinical trials on a 15-month contract, ensuring timely study deliverables, regulatory compliance, and effective coordination with both internal teams and external service providers. All applicants must have authorization to work in the US.

Key Responsibilities

• Serve as the main point of contact and coordination for assigned trials
• Ensure overall completeness and inspection readiness of the TMF for studies
• Develop, manage, review, and track study budgets, contracts, and external change orders
• Provide accurate study drug utilization forecasts, and approve labeling and procurement of supplies
• Develop and finalize study-specific documents such as the Pharmacy Manual and monitoring plans
• Oversee site activation, investigator feasibility, management of site issues, and study close-out activities
• Manage study timelines, operational plans, and monitor CRO performance to achieve deliverables on time and within budget
• Collaborate with internal functional groups and external service providers to ensure compliance with GCP and local regulations
• Identify and resolve study-level risks and support audit/inspection processes
• Provide guidance and mentorship to junior Clinical Operations staff

Required Qualifications

• 6 years in clinical research and development
• At least 1 year managing a Phase 1-3 interventional trial
• Advanced knowledge of ICH-GCP
• Excellent interpersonal, verbal, and written communication skills
• Strong organizational skills with an ability to multi-task and pay close attention to detail
• Proficiency in clinical project management tools and software such as Veeva eTMF and Medidata EDC

Preferred Qualifications

• Bachelor’s degree
• 3 years of onsite monitoring, auditing, or site management experience
• 2 years managing key clinical study deliverables and external service providers

Benefits & Perks

• Compensation: $140,000-$155,000 USD
• Competitive salaries
• An excellent benefit package