Arrowhead Pharmaceuticals
Associate Director, Clinical Operations, TMF Head
Arrowhead Pharmaceuticals, San Diego, California, United States, 92154
Associate Director, Clinical Operations, TMF Head Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical-stage biopharmaceutical company developing medicines for intractable diseases by silencing disease-causing genes. Using a broad portfolio of RNA chemistries and delivery methods, Arrowhead therapies utilize RNA interference to achieve rapid, deep, and durable gene knockdown. RNAi is a natural cellular mechanism that inhibits gene expression, affecting specific protein production. Arrowhead’s RNAi therapeutics leverage this pathway to target various diseases.
Ensure you read the information regarding this opportunity thoroughly before making an application. The company focuses on developing innovative drugs for genetically based diseases characterized by overproduction of certain proteins. Our versatile RNAi technologies enable us to address conditions across many therapeutic areas, including those not accessible by small molecules or biologics. Arrowhead is at the forefront of applying RNAi outside the liver, with clinical pipelines targeting liver and lung diseases, alongside a strong pipeline of preclinical candidates. Headquartered in Pasadena, CA, with research and development in Madison, WI, and San Diego, CA, and a manufacturing facility in Verona, WI, our team consists of nimble, science-driven innovators committed to bringing new therapies to patients. The Position The primary purpose of this role is to oversee the eTMF process and vendor management, ensure compliance with GCP standards, and provide guidance on clinical operations best practices. Additionally, the Associate Director of Clinical Standards & Processes will track and update SOPs/WIs and coordinate with Quality Assurance to maintain GCP compliance. Responsibilities
Provide leadership and oversight on study-related issues involving the eTMF, unblinded tasks, and company processes. Serve as the eTMF system administrator and trainer for internal and external stakeholders. Manage Clinical Operations staff in eTMF setup, maintenance, quality control, and final reconciliation of study documents. Ensure staff receive GCP/SOP/WI training and periodic refreshers. Establish metrics and tracking systems for proactive, risk-based quality management. Oversee clinical vendor management and escalate issues as needed. Collaborate with QA on inspection preparations and provide leadership during audits and inspections. Facilitate continuous quality improvement through audit reporting, CAPAs, and GCP guidance. Contribute to the development of Clinical Operations documents such as forms, templates, SOPs/WIs. Ensure process standardization across Clinical Operations. Work with cross-functional teams (Safety, Regulatory, Legal, Finance, Project Management, QA) to ensure operational efficiency. Manage direct reports. Requirements
Minimum 10 years of experience in clinical operations, clinical quality, or QA roles, with at least 3 years in a managerial or lead capacity, and 2 years in clinical monitoring (preferred). At least 3 years of Veeva eTMF management experience. Solid knowledge of US, EU, and international clinical trial regulations (ICH GCP, FDA, EMA, ANZ). Experience with inspections. Strong vendor management skills and experience managing electronic Trial Master Files (Veeva eTMF). Preferred Qualifications
Master's degree in a Science discipline. Knowledge of industry compliance trends. California pay range: $180,000—$200,000 USD. Arrowhead offers competitive salaries and excellent benefits. Applicants must have authorization to work in the US. For more details, see the California Applicant Privacy Policy. Additional Information
Seniority level: Director Employment type: Full-time Job function: Research, Analysis, and Information Technology Referrals increase your chances of interviewing at Arrowhead Pharmaceuticals. Set up job alerts for roles such as Associate Director Clinical Operations, Clinical Trial Manager, and others.
#J-18808-Ljbffr
Ensure you read the information regarding this opportunity thoroughly before making an application. The company focuses on developing innovative drugs for genetically based diseases characterized by overproduction of certain proteins. Our versatile RNAi technologies enable us to address conditions across many therapeutic areas, including those not accessible by small molecules or biologics. Arrowhead is at the forefront of applying RNAi outside the liver, with clinical pipelines targeting liver and lung diseases, alongside a strong pipeline of preclinical candidates. Headquartered in Pasadena, CA, with research and development in Madison, WI, and San Diego, CA, and a manufacturing facility in Verona, WI, our team consists of nimble, science-driven innovators committed to bringing new therapies to patients. The Position The primary purpose of this role is to oversee the eTMF process and vendor management, ensure compliance with GCP standards, and provide guidance on clinical operations best practices. Additionally, the Associate Director of Clinical Standards & Processes will track and update SOPs/WIs and coordinate with Quality Assurance to maintain GCP compliance. Responsibilities
Provide leadership and oversight on study-related issues involving the eTMF, unblinded tasks, and company processes. Serve as the eTMF system administrator and trainer for internal and external stakeholders. Manage Clinical Operations staff in eTMF setup, maintenance, quality control, and final reconciliation of study documents. Ensure staff receive GCP/SOP/WI training and periodic refreshers. Establish metrics and tracking systems for proactive, risk-based quality management. Oversee clinical vendor management and escalate issues as needed. Collaborate with QA on inspection preparations and provide leadership during audits and inspections. Facilitate continuous quality improvement through audit reporting, CAPAs, and GCP guidance. Contribute to the development of Clinical Operations documents such as forms, templates, SOPs/WIs. Ensure process standardization across Clinical Operations. Work with cross-functional teams (Safety, Regulatory, Legal, Finance, Project Management, QA) to ensure operational efficiency. Manage direct reports. Requirements
Minimum 10 years of experience in clinical operations, clinical quality, or QA roles, with at least 3 years in a managerial or lead capacity, and 2 years in clinical monitoring (preferred). At least 3 years of Veeva eTMF management experience. Solid knowledge of US, EU, and international clinical trial regulations (ICH GCP, FDA, EMA, ANZ). Experience with inspections. Strong vendor management skills and experience managing electronic Trial Master Files (Veeva eTMF). Preferred Qualifications
Master's degree in a Science discipline. Knowledge of industry compliance trends. California pay range: $180,000—$200,000 USD. Arrowhead offers competitive salaries and excellent benefits. Applicants must have authorization to work in the US. For more details, see the California Applicant Privacy Policy. Additional Information
Seniority level: Director Employment type: Full-time Job function: Research, Analysis, and Information Technology Referrals increase your chances of interviewing at Arrowhead Pharmaceuticals. Set up job alerts for roles such as Associate Director Clinical Operations, Clinical Trial Manager, and others.
#J-18808-Ljbffr