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 Clinical Trial Associate (CTA) provides administrative support to the Clinical Operations Department. The primary purpose of the position is to facilitate efficient clinical trial planning and execution.
Responsibilities
- Set up and maintain clinical trial master files (hardcopy and/or electronic format) in compliance with SOPs
- Develop and maintain study tools including trackers, spreadsheets, and filing systems for various studies
- Preparation and revision of Purchase orders; follow-up with vendors on invoice issues
- Plan and coordinate department meetings and activities, as requested, including handling logistics, preparation of agendas, distribution of meeting materials
- Assist COMs with drug and ancillary supply management
- Assist with preparation of study related documents and presentations
- Assist Associate Director with Clin Ops SOP/WI team training
- Assist COMs with eTMF filing and reconciliation as needed
- Attend department meetings and record minutes as requested
- Facilitate initiation of and track study agreements and contracts for COMs
- QC study related documents (Protocols, ICFs, Study Plans, etc.)
- May function as a liaison between clinical vendors on behalf of COMs
- Manage off-site document storage and recall as applicable
- Any other study related tasks assigned by Clinical Operations Team members
Requirements
- 1 year of experience in similar industry position
- Pharmaceutical or biotechnology environment experience andvalued but not mandatory
- Ability to multi-task and prioritize effectively with input from manager or Study Lead
- Proficient interpersonal, verbal and written communication skills
- Ability to work effectively independently and in a collaborative team environment
- Basic software skills (MS-Outlook, Word, Excel, DocuSign)
- Ability to perform Key Duties and Responsibilities in a timely manner and with minimal supervision
Preferred
- 4-year college degree preferred
- Basic understanding of Good Documentation Practice (GDP) and ICH-GCP
- Ability to readily identify and categorize essential document types as defined by ICH E6 for submission to TMF
- Proficiency in Veeva eTMF
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.
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Top Skills
What We Do
Arrowhead Pharmaceuticals is a clinical stage, Nasdaq listed (ticker ARWR) company developing medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, our 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. Our RNAi-based therapeutics are at the leading edge of genetic-based therapy with the potential to bring life changing treatments for patients.
Our Targeted RNAi Molecule (TRiMTM) platform utilizes ligand-mediated delivery and is designed to enable tissue-specific targeting while being structurally simple. The TRiM platform builds on more than a decade of work on actively targeted drug delivery and offers several advantages including simplified manufacturing and reduced costs; multiple routes of administration; and potential for improved safety.
Our employees are nimble, science-driven, and innovative professionals. A career at Arrowhead offers the opportunity to collaborate with top notch scientists to rapidly discover and develop RNAi-based therapeutics to add to our growing pipeline.
Research and development activities are located in Madison, WI. Our R&D group includes fully-integrated capabilities for chemistry, biology, and toxicology. Madison is an exciting and sophisticated city that includes state government, the flagship campus of the University of Wisconsin, and major research organizations.
Our HQ, clinical and regulatory operations are located in Pasadena, CA. Just north of Los Angeles and resting in the foothills of the San Gabriel Mountains, Pasadena is known for its natural scenic beauty, vibrant cultural and academic environment and rich architectural setting.
