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 specified gene, thereby affecting the production of a specific protein. Our RNAi-based therapeutics are at the leading edge 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 targeted RNA 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, innovative professionals. A career at Arrowhead offers the opportunity to collaborate with top notch scientists to rapidly discover and develop RNAi-based therapeutics in a variety of indications to add to our growing pipeline.
Arrowhead seeks an experienced clinical data management leader to join its clinical development team. The Director of Data Management is responsible for providing expertise and operational leadership of the clinical data management (CDM) function of CDM activities for all clinical trials.
- Serve as the interdepartmental subject matter expert for the CDM area to enable planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data for internal decision-making, regulatory approval and market acceptance;
- Evaluate, recommend, implement and lead processes, infrastructure development and staffing to build Arrowhead’s CDM function for its growing clinical pipeline, including electronic data capture, external data integration, ad-hoc analysis and end-to-end data standards;
- Interface with internal stakeholders including regulatory affairs, program management, and R&D to assess and meet data management needs; represent CDM function in project team activities and meetings;
- Manage interface with CROs, clinical sites and laboratories to ensure the efficient and timely collection of clinical data;
- Oversee identifying, locating, evaluating and validating CDM documents and databases required for report generation or regulatory submission;
- Generate data listings or other data review tools for reporting of study metrics;
- Evaluate and select CDM vendors; lead vendor activities for clinical trial data collection to ensure quality and timely deployment;
- Support clinical study report creation with input to the data quality assurance section as well as provisioning of sample and completed eCRFs, etc;
- Ensure compliance from a CDM perspective regarding protocols, SOPs and overall clinical objectives; develops SOP as needed;
- Other related duties, as assigned.
- Bachelor’s degree or Master’s degree in a related field
- 6+ years of supervisory and management experience
- 10+ years of clinical data management experience
- Strong understanding of the clinical data management process including CDASH and SDTM data formats, and familiarity with physiology, pharmacology, clinical study objectives and methodologies.
- Excellent understanding of the clinical trial database life cycle including CRF design, database development and testing, discrepancy management, data quality review and database close and lock procedures
- Expert knowledge of industry leading eCRF tools
- Good understanding of database and dictionary structures (e.g., MedDRA)
- Good Clinical Data Management Practices (GCDMP) understanding
- Good Clinical Practices ICH GCP guidelines understanding
- Ability to travel domestically and internationally up to 10%
- Certified Clinical Data Manager (CCDM)
- Experience managing contract and/or permanent CDM staff members
- Project management experience in a team setting within the biotech/pharmaceutical industry
- Global trial expertise
- SAS and PL/SQL, as well as other relevant programs
- Demonstrated experience preparing and managing project budgets and timelines
- Experienced in a senior clinical data management role within a CRO
Please submit a resume and cover letter to email@example.com.
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the U.S. for a company.