Senior Manager, Clinical Standards & Processes at Arrowhead Pharmaceuticals

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

22 May, 26

Salary

170000.0

Posted On

21 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

TMF Lead, eTMF System Administration, GCP, SOP/WI Compliance, Vendor Management, Metrics Tracking, Quality Control, Audit Preparation, CAPA Management, Process Improvement, Clinical Operations Documentation, Veeva eTMF, Risk-Based Quality Management, ICH GCP, FDA Regulations, EMA Regulations

Industry

Biotechnology Research

Description

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 of Clinical Standards & Processes (CS&P) will act as the internal TMF lead on all studies, ensuring oversight to outsourced TMF work (vendor and/or CRO) and performing oversight to TMF metrics and trends. In addition, the Senior Manager of CS&P may be tasked with projects that ensure proper framework of TMF related processes and ongoing compliance to Standard Operating Procedure/ Work Instruction (SOP/WI) and Good Clinical Practice (GCP)/Good Documentation Practice (GDP). 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. Responsibilities 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, and company processes. Ensure the collection of metrics and tracking systems to facilitate a proactive, risk-based quality management Assist Associate Director with eTMF system administration functions (CS&P is the business owner of the eTMF system). Manage eTMF and Study TMF training for internal and external user access. Oversee CS&P role in eTMF user access process in accordance with applicable SOP/WI and escalate issues as required to Senior Management Direct junior CS&P staff with eTMF set-up, maintenance, ongoing quality control review, and final reconciliation of study 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 Support the Associate Director of CS&P and Clinical Operation Senior Management in leading various process improvement initiatives. May manage direct reports. Requirements Minimum of 8 years of relevant experience in clinical operations/clinical quality or quality assurance role/ minimum of 2 years in a managerial or lead role/ minimum of 3 years in TMF experience (preferred). Minimum 2 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 (eTMFs). Preferred Bachelor’s degree in a Science discipline Knowledge of industry compliance trends Proficient in Smartsheets California pay range $140,000—$170,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Responsibilities

The Senior Manager will act as the internal TMF lead, ensuring oversight of outsourced TMF work, managing TMF metrics, and ensuring compliance with GCP and GDP across programs. This role primarily involves overseeing the eTMF process and vendor, providing guidance to Clinical Operations, and contributing to process improvement initiatives.