Title: Associate Director, Project Management Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera's mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera's lead product candidate is atacicept, a fully humanized fusion protein self-administered at home as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells and plasma cells to produce galactose-deficient IgA1 (Gd-IgA1) and associated autoantibodies. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus. For more information, please visit: .
Position Summary We are seeking a highly skilled and motivated Associate Director, Project Management. The ideal candidate will work with the Regulatory team to develop project plans and ensure that these are clearly communicated to cross-functional team members and internal stakeholders.
Responsibilities: Providing BLA Project Management support including timeline development, issue and risk management, status reporting and meeting facilitation. Work with other project managers to integrate module timelines and deliverables into the overall BLA plans. Support development and maintenance of the Smartsheet environment necessary to manage BLA filing. Leading the cross-functional team to develop responses to health authority questions globally. Integrate activities and timelines with other functional areas including Clinical, Clinical Operations, and CMC. Provide project management support for briefing documents and agency meetings. Coordinate submission scheduling with regulatory publishing. May support other programs. Qualifications: BA/BS degree with 8+ years of biotechnology industry experience required. In-depth knowledge of some aspects of the biopharmaceutical industry, biologic development is preferred. Experience in Regulatory and BLA/NDA filing preferred. Experience in Smartsheet is preferred. High level of accuracy and attention to details. Proficient in Microsoft Office, including Word, Excel, Project, Visio, or other timeline tools. Ability to work with ambiguity and create more efficient processes. Ability to communicate effectively with stakeholders across the organization at all levels. Proven ability to manage competing priorities, budgets, and timelines in a fast-paced environment. Highly skilled at working collaboratively with cross-functional teams and contractors. Ability to distill, organize, and effectively communicate key messages from complex discussions. Self-directed and proactive with ability to function independently. Ability to deal with uncertainty and generate options for moving forward. Vera Therapeutics Inc. is an equal-opportunity employer.
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