Senior Director, Clinical Data Management

Senior Director, Clinical Data Management Bothell, Washington, United StatesCompany OverviewImmunome is a clinical-stage targeted oncology company committed to developing first- and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs). In addition to a portfolio of discovery-stage ADCs, our pipeline includes AL102, a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors, as well as IM-1021, a ROR1 ADC, and IM-3050, a FAP-targeted radioligand, both of which are the subject of INDs expected to be submitted in the first quarter of 2025.Position OverviewThe Senior Director of Clinical Data Management will be responsible for leading our data management operations within clinical trials. This role will oversee the planning, execution, and management of clinical data management activities to ensure the highest quality of data for regulatory submissions and publications.ResponsibilitiesDevelop and implement the strategic vision for clinical data management, aligning with company goals and regulatory requirements.Oversee the design, implementation, and maintenance of data management processes, standards, and systems for clinical trials.Act as a key point of contact for data-related inquiries from stakeholders and regulatory bodies.Establish and maintain data quality standards and metrics to ensure compliance with regulatory guidelines (e.g., FDA, EMA).Lead audits and inspections related to clinical data management processes and systems.Collaborate with clinical operations, biostatistics, and regulatory affairs teams to ensure seamless integration of data management activities.Identify and implement technological advancements to improve data management efficiency and effectiveness.Lead and mentor a team of data managers and analysts, fostering a culture of continuous improvement and collaboration.QualificationsBachelor’s degree in life sciences, pharmacy, or a related field.A minimum of 10 years of industry experience in clinical trial management. At least 5 years in a leadership role within the biopharmaceutical industry is strongly preferred.In-depth knowledge of clinical trial processes, data management methodologies, and regulatory requirements is required.Knowledge and SkillsProven experience of successfully managing large-scale clinical data projects.Extensive knowledge of GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM Best Practices.Extensive knowledge of data privacy requirements for data collection of clinical trial data and information.Proficient in Medidata Rave and / or other EDC platform study builds.Extensive experience working with and managing CROs / external vendors.Experience writing SOPs, work instructions, and guidelines preferred.Experience with NDA / BLA activities preferred.Experience with regulatory inspection / audit preparation.E / E / OImmunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.Washington State Pay Range$260,000 - $287,812 USD#J-18808-Ljbffr

Salary : $260,000 - $287,812