Clinical Operations
Associate Director, Clinical Standards & Processes
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 primary purpose of the position is to oversee the eTMF process and vendor, ensure compliance with GCP and consistency across the programs, and to provide guidance and best practices to Clinical Operations. In addition, the Associate Director of Clinical Standards & Processes will be tasked with tracking and ongoing Standard Operating Procedure/ Work Instruction (SOP/WI) review and updates as well as aligning with Quality Assurance (QA) to ensure Good Clinical Practice (GCP).
Responsibilities
- Provide leadership, guidance and oversight on study related issues pertaining to the eTMF, unblinded tasks, and company processes.
- eTMF system administrator and trainer for all internal and external
- Direct Clinical Operations staff with eTMF set-up, maintenance, ongoing quality control review, and final reconciliation of study
- Ensure staff is provided GCP/SOP/WI training for Clinical Operations staff and refreshers where applicable.
- Ensure the collection of metrics and tracking systems to facilitate a proactive, risk-based quality management
- Oversee clinical vendor management and escalate issues as required to Senior
- Collaborate with Quality Assurance on health authority inspection preparation activities and provide leadership and oversight during
- Collaborate with Quality Assurance with the preparation, conduct and response to internal and external audits/inspections, as applicable.
- Facilitate ongoing quality improvement through communication of audit results, CAPAs and GCP guidance and consultation to COM and Senior Management, as
- Contribute to the development of Clinical Operations documents (forms, templates, SOPs/Wls).
- Ensure consistency and standardization of processes across Clinical Operations.
- Collaborate with other cross functional areas (Safety, Regulatory, Legal, Finance, Project Management and QA) to ensure operational
- Manage direct reports.
Requirements:
- 10 years of relevant experience in clinical operations/clinical quality or quality assurance role/ minimum of 3 years in a managerial or lead role/ minimum of 2 years in clinical monitoring experience (preferred).
- 3 years Veeva eTMF experience in a management role.
- Fundamental knowledge of US, EU and international regulatory standards and guidelines for the conduct of clinical trials (ICH GCP, FDA; EMA; ANZ regulations)
- Experience in inspection
- Strong knowledge/experience in vendor management, clinical operations and management of electronic Trial Master Files (Veeva eTMF).
Preferred:
- Master’s degree in a Science discipline
- Knowledge of industry compliance trends
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.