Associate Director Project Management (Medical Affairs)
Title: Associate Director, Project Management (Medical Affairs) Location: Brisbane, CA/Remote About Us: Vera Therapeutics... more info
Title: Associate Director, Project Management Location: Brisbane, California About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-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 weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy. Vera is also considering evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing VT-109, a novel, next- dual BAFF/APRIL inhibitor in preclinical development, and MAU868, a monoclonal antibody designed to neutralize infection with BK virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information, please visit: . Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do, from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases. Position Summary We are seeking a highly skilled and motivated Associate Director, Project Management. The ideal candidate will work with the Clinical Research and Research team to develop project plans and to ensure that these are clearly communicated to cross-functional team members and internal stakeholders. Responsibilities: Leading the cross functional team to develop clinical development plans and associated deliverables including clinical synopses and protocols. Integrate activities and timelines with other functional areas including Clinical Operations, Biometrics, Pharmacology and CMC. Project manage early-stage development activities including within CMC (developability, GLP and GMP material creation) and pre-clinical (tox studies, dose range finding etc.). Provide project management support for briefing documents and agency meetings (pre-IND, type B meetings). Report regularly on project status, risks, and outcomes to senior management and other key stakeholders. Provide BLA Project Management support including timeline development, issue and risk management, status reporting and meeting facilitation both generally and for specific modules. Work with other project managers to integrate module timelines and deliverables into the overall BLA plans. 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. Experience in Clinical Research, early-stage development. Prior experience with in-vitro, in-vivo pharmacology. IND/NDA/BLA filing experience is preferred but not required. Experience in Smartsheet is preferred but not required. 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 new, more efficient processes. Desire to bring order and organization to a newly developing organization. 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, rapid-growth environment. Highly skilled at working collaboratively with cross-functional teams and contractors to drive results and meet company objectives. Ability to distill, organize, and effectively communicate (verbal and written) key messages from complex discussions. Self-directed and proactive with ability to function independently in certain situations, exercise good judgment and respond quickly and effectively to changing environments. Ability to deal with uncertainty and unanticipated challenges in a constructive manner and generate options for moving forward. Vera Therapeutics Inc. is an equal-opportunity employer. Vera Therapeutics is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $139,000 - $183,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience. At Vera, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Vera Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays. #J-18808-Ljbffr
Title: Associate Director, Project Management (Medical Affairs) Location: Brisbane, CA/Remote About Us: Vera Therapeutics... more info
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