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The QA Specialist / Senior Specialist will be responsible for supporting all quality assurance activities related to development and commercial programs and products including, but not limited to, batch manufacturing and testing records, labelling, packaging and shipping records, QC test results, deviations, change requests SOP and batch record generation and revision, and the generation of documentation metrics.
The senior specialist may be part of a dynamic QA team responsible for CMO compliance and final product release.
Assist and coordinate the day-to-day administration of facility and corporate services under general supervision. Daily work encompasses a wide range of responsibilities including Reception, Shipping & Receiving, Administrative and Facilities.
Manages the design, maintenance and locking of clinical trial databases. Acts as the data management team lead on all clinical study data issues when activities are outsourced, between Dynavax and a contract research organization, or other vendors
Supports all clinical trial statistical programming activities, including writing and reviewing specifications, developing SAS programs to create CDISC-conforming data tabulations and analysis datasets and generate statistical outputs such as tables, listings and figures, reviewing and validating programmed datasets as well as statistical outputs produced in-house or by contract research organization (CRO) products, and coordinating the work of other statistical programmers.
This position may provide technical and project oversight of contract programmers.
This position is responsible for delivering strategic and tactical insights to our sales and marketing partners based on analyses of various large data sources. Using various statistical and analytical techniques, the Analytics Manager will participate in Dynavax’s commercial planning efforts by providing unbiased, objective answers to critical business questions.
Provide leadership and management oversight of clinical document control and clinical training, including managing the day-to-day operations of the clinical documentation archive, the team responsible for managing the TMF/eTMF , and maintenance and tracking of training records. Partner with Clinical Development, Quality Assurance, and Regulatory Affairs to enable the development and maintenance of Standard Operating Procedures (SOPs) and clinical records. Ensure Clinical Development is appropriately trained on SOPs. Implement process improvement initiatives such as e-sign, system improvements for eTMF to ensure continued adherence to regulatory requirements and inspection-readiness Develop and maintain Trial Master File SOPs.
This position is responsible for providing professional project management services to support key programs at Dynavax. The Associate Director, PM, will co-lead teams with the Project Team Leaders and will operationally manage R&D development plans for Clinical, Regulatory and for communications with significant independence.
Working with Project Leaders, this position will translate project strategies to project plans and manage project timelines, budgets and ensure adequate resources exist to achieve key milestones
PRIMARY PURPOSE OF POSITION:
Responsible for performing multiple tasks that support clinical trials, with duties that include assisting clinical operations staff with activities related to clinical trials, creating and maintaining documents and tracking systems, maintaining accurate files and filing systems, etc.
The Revenue Manager has ownership of all aspects of revenue recognition and must understand, analyze, and communicate financial impacts throughout the organization. This role will routinely partner with others across multiple functions ensuring proper alignment with policies and controls for revenue recognition and reporting, in accordance with US GAAP.
This position will have responsibilities in monthly, quarterly, and year-end financial statement close. Responsible for accounting activities including, but not limited to, accruals of clinical research and development expenses, consolidations, prepaid assets, project allocation of labor and other expense, account reconciliations and analysis.
The Senior Accountant independently applies principles of accounting to analyze financial information and prepare financial reports
This position is principally responsible, both individually as well as through external consultants, for the configuration, customization, security, support, integrity and management of Microsoft Dynamics AX in support of the finance function. As a strong business partner to the finance team, this position understands the business challenges and opportunities and works to lead the configuration and maintenance of value added solutions to meet the set business requirements and financial reporting needs. Additionally, this position is responsible for troubleshooting and problem resolution, management of system resources and performance, and support and maintenance of other finance system environments, as required.
Additionally, this position will collaborate with the various departments and IT to coordinate and manage the design, development, implementation and on-going support of other business applications including but not limited to defining system components, component interactions and interfaces, and the technologies and resources to be used with the business solutions.
This position is responsible for the design, development, modification and evaluation of a technical infrastructure to expedite conduct and evaluation of clinical trials and basic research. Duties will include but not be limited to collaborating with project team to determine protocol design and develop statistical analysis plan; working with clinical data manager and clinical team to ensure quality data collection; interacting with statistical programmers to develop specification documents for creating CDISK-conforming analysis datasets and statistical outputs including summary tables, listings and figures; ensures appropriateness and accuracy of statistical outputs to support the development of clinical study reports, regulatory submissions, presentations and publications; and performing statistical analysis and research as necessary.
The QA manager position provides QA support and oversight to ensure compliance with Good Clinical Practice (GCP). Areas of responsibility include:
- Participate in development of Clinical and Clinical QA standard operating procedures (SOPs) and policies;
- Manage audits of investigator sites, vendors/CROs, trial master files, data/CRFs, and study documents (eg, protocol, clinical study reports) for clinical trials.
Serve as QA GCP representative at project meetings.
As a member of the Analytical Development team, this role will support the early to late stage drug development programs at Dynavax including oligonucleotides, peptides, and proteins. The successful candidate may develop, transfer, and qualify analytical methods for drug substance and drug product release, stability and characterization.
This position will support early- to late-stage development focused on formulation and compatibility studies.