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.
The Accounting Manager will oversee the implementation and adherence to accounting policies and procedures and direct and coordinate the daily activities of the accounting staff to ensure timely and accurate record of the expenditures, assets, liabilities and equity transactions of the Company. This position is responsible for meeting deadlines and will direct a multitude of accounting activities including but not limited to monthly close process, reconciliations and year-end audit preparation.
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 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.
The primary responsibilities of the position are to architect, design and implement IT Cloud Services, Disaster Recovery and Security Infrastructure Services. Additional responsibilities include but not limited to management of the IT Infrastructure and Security Operations, as well as ensure IT’s operational excellence in supporting current and future business requirements.
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.