Senior Director, Regulatory Affairs CMC Bothell, Washington, United States

Immunome 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 Overview Immunome is seeking a Senior Director, Regulatory Affairs CMC who will be responsible for directing the Company's global regulatory CMC strategies. This role contributes to the organization's goals and objectives regarding overall regulatory affairs and ensures they are achieved. This individual is responsible for leading CMC submissions and communications with global regulatory authorities. This individual has the overall responsibility for managing required resources and meeting an aggressive regulatory submission schedule necessary to ensure the effective fulfillment of goals and objectives. This role will be a key partner with the CMC organization and acts as an advisor to senior management to ensure alignment with regulatory CMC development and registration strategies. This position will report to the Vice President, Regulatory Affairs. Responsibilities Lead the development and execution of regulatory CMC strategies from early to late phase development through registration. Provide strategic input and regulatory guidance to CMC operations, supply chain, quality and project teams on CMC matters. Proactively identify CMC issues via risk assessments provide contingency and mitigation plans. Communicate CMC regulatory strategy, key issues and remediation activities needed throughout project/product life cycle to management levels within the organization and other key stakeholders. Build strong collaboration with internal stakeholders, including CMC, supply chain, quality, clinical and non-clinical departments. Oversee the preparation of regulatory CMC documentation for inclusion in regulatory submissions including INDs, CTAs, pediatric plans, annual reports, and marketing applications. Lead the strategic development of responses to CMC related questions from health authorities and work with functional groups to provide timely responses. Oversee activities for CMC meetings with FDA and global regulatory authorities, lead negotiations and interactions with regulatory authorities on CMC matters. Interpret and communicate regulatory CMC expectations to internal and external stakeholders (including partners, CROs, CMOs, consultants, and contractors) to execute program objectives in compliance with applicable regulations. Maintain current knowledge of regulations and guidelines (e.g., ICH, FDA, EMA) and keep abreast of changes in the global regulatory environment. Support regulatory inspections, as required. Qualifications Bachelor’s degree in a relevant scientific discipline. A minimum of 10 years in global regulatory affairs in the pharmaceutical/biotechnology industry. Extensive experience with CMC small molecule development in late phase development and commercial stage programs, experience with biologics is a plus. Proven success in leading regulatory submissions and obtaining approvals in major markets. Knowledge and Skills Direct experience leading regulatory submissions, health authority meetings and interactions with in-depth knowledge of the internal operations and outlook of the FDA, EMA and other global health authorities. Has a comprehensive and disciplined approach to CMC risk management and regulatory compliance through deep expertise and understanding of CMC technical development and manufacturing, quality, and supply chain. Highly collaborative self-starter and team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders. Outstanding communication, analytical, organizational and time management skills. Experience and passion to work with small teams, ability to work comfortably under pressure under evolving scenarios and tight deadlines. Detail-minded yet flexible work style; manage multiple projects and timelines simultaneously, and rapidly change priorities based on business needs. Washington State Pay Range: $226,000 - $270,000 USD E/E/O Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Apply for this job #J-18808-Ljbffr