Associate Director
Clinical Operations Standards & Processes
Confirmed live in the last 24 hours
Arrowhead Pharmaceuticals

201-500 employees

RNAi-based gene-silencing therapeutics
Company Overview
Arrowhead Pharmaceuticals stands out in the biopharmaceutical industry through its focused application of RNA interference (RNAi) mechanisms to develop targeted therapies for genetic diseases, exemplified by its candidate plozasiran aimed at reducing ApoC3 protein levels to manage severe hypertriglyceridemia. The company's proprietary TRiM platform demonstrates a competitive edge by enabling tissue-specific gene silencing, which has shown promise in early clinical trials, such as the AROAPOC3-2001 study, to improve lipid levels safely and effectively. Arrowhead's approach to drug development not only streamlines manufacturing and potentially reduces costs but also positions the company as a leader in RNAi therapeutics, with ongoing research that could transform treatment paradigms for patients with lipid disorders.
Biotechnology

Company Stage

N/A

Total Funding

$899.9M

Founded

2004

Headquarters

Pasadena, California

Growth & Insights
Headcount

6 month growth

10%

1 year growth

32%

2 year growth

63%
Locations
Pasadena, CA, USA • San Diego, CA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Communications
Management
Quality Assurance (QA)
CategoriesNew
Medical, Clinical & Veterinary
Diagnostics & Laboratory Professionals
Healthcare Administration & Support
Requirements
  • Minimum of 10 years of relevant experience in clinical operations/clinical quality or quality assurance role/ minimum of 5 years in a managerial or lead role/ minimum of 2 years in clinical monitoring experience
  • 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 management
  • Strong knowledge/experience in vendor management, clinical operations and management of electronic Trial Master Files (eTMFs)
Responsibilities
  • Facilitate New Hire Orientation in collaboration with HR for Pasadena & San Diego Staff
  • Onboard all new Clinical Operations staff members to Clinical Operations specific functions
  • Ensure staff is provided GCP/SOP/WI training for Clinical Operations staff and refreshers where applicable
  • Provide leadership, guidance and oversight on study related issues pertaining to the eTMF, unblinded tasks, and company processes
  • Ensure the collection of metrics and tracking systems to facilitate a proactive, risk-based quality management approach
  • eTMF system administrator and trainer for all internal and external users
  • Direct Clinical Operations staff with eTMF set-up, maintenance, ongoing quality control review, and final reconciliation of study documents
  • Oversee clinical vendor management and escalate issues as required to Senior Management
  • Collaborate with Quality Assurance on health authority inspection preparation activities and provide leadership and oversight during inspections
  • 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 required
  • 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 area (Safety, Regulatory, Legal, Finance, Project Management and QA) to ensure operational excellence
  • Manage direct reports