Senior Director, Evidence Generation

vor 1 Woche

Brisbane, Österreich - Vollzeit

Job DescriptionTitle: Senior Director, Medical Affairs, Evidence GenerationLocation: Brisbane, California / RemoteAbout 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, which together form immune complexes that are fundamental in the pathogenesis of IgA nephropathy (IgAN). Vera is also considering evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing 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: www.veratx.com.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:The Senior Director, Evidence Generation will report to the Executive Director, Health Economics and Outcomes Research and will be responsible for leading Vera evidence generation initiatives and programs.As the Senior Director, Evidence Generation, you will develop and execute a comprehensive strategy to support evidence generation and decision-making across the organization. This position involves leading design and implementation of studies analyzing real-world data to generate insights into diseases, treatment patterns, and outcomes including the safety and effectiveness of Vera products in real-world settings. Understanding and aligning with clinical development team goals is essential. The role requires both a broad knowledge of drug development, including clinical trials and application of RWE in drug development. The ideal candidate will have a deep understanding of healthcare data sources, advance analytics methodologies, and regulatory and payer evidentiary standards and requirements, coupled with strong leadership skills to drive cross-functional collaboration and influence decision-making at all levels.Responsibilities:Co-lead a cross-functional evidence generation function for the assigned compound in partnership with HEOR function and Medical Affairs.Communicate progress to relevant internal stakeholders using appropriate trackers and tools.Serve as a delegate on relevant concept and protocol review committees (for company-sponsored and externally sponsored research).Utilize appropriate study designs including Vera-sponsored observational trials, disease/products registries, and retrospective database analyses.Identify, assess, and select real-world data sources considering balancing issues such as data relevance and data quality against context of use (i.e., regulatory-grade evidence for external partners vs. rapid insights generation for internal decision-making).Ensure compliance with recognized and accepted good research practice standards that govern the use of real-world data in evidence generation activities.Communicate findings to external audiences via abstracts/posters and publications in relevant peer-reviewed medical and scientific journals.Establish partnerships with external stakeholders, including academic institutions, healthcare providers, payers, and regulatory agencies, to access and leverage real-world data assets.Represent the company in external forums, conferences, and publications to enhance the company's reputation as a leader in real-world evidence.Qualifications:Advanced degree (PharmD, PhD, MD or equivalent).5+ years of experience in pharma/biotech industry or equivalent experience in a related field with a record of accomplishment of leadership and innovation.Launch preparation and delivery in Global, Regional or Country Medical Affairs required.Experience planning and conducting Medical Affairs interventional and non-interventional studies, including Ph 3b/4, expanded access program (EAP), externally sponsored research, external clinical collaborations, and observational studies required.Deep understanding of real-world data sources, study design methodologies, statistical analysis techniques, and good research practices governing RWE generation.Proven leadership skills, including the ability to build and motivate high-performing teams, influence stakeholders, and drive organizational change.Strong project management skills, with the ability to prioritize and manage multiple projects simultaneously in a fast-paced environment.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 begins at $258,000. 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.
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