Oncology Sales Director

Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been submitted to the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-3050, an IND-cleared FAP-targeted radiotherapy; and IM-1617, an IND-cleared solid tumor ADC. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets. Position Overview Immunome is seeking an experienced and strategic Director, Commercial Distribution to lead distribution strategy and day-to-day channel operations for current and future oncology products. This role will design, implement, and continuously improve Immunome’s distribution model and supporting processes to ensure compliant, efficient product flow through specialty distributors, third-party logistics (3PL) providers, and specialty pharmacy networks.   The Director will be the primary point of contact for distribution partners, oversee contract execution and performance (including quarterly business reviews), and partner cross-functionally with Supply Chain, Finance, Managed Markets, Patient Services, Legal/Compliance, IT, and Commercial Operations to support launches and prepare for portfolio growth. The director will be a proven leader, willing to accept new challenges and increased responsibilities in a rapidly growing organization. This position will report to the Executive Director, Commercial Enablement.   Responsibilities Distribution Strategy and Network Design   * Develop and execute Immunome’s commercial distribution strategy aligned to access and commercial objectives.  * Design and optimize the distribution network across specialty distributors, wholesalers (as applicable), 3PL, and specialty pharmacies for oral oncology launches and lifecycle changes.   * Own distribution policies and business rules (eligibility, order limits/allocations, returns, drug replacement) to ensure consistent, scalable execution.   Channel Operations and Issue Resolution   * Lead daily distribution operations; monitor order-to-cash and resolve issues (customer onboarding, order approvals, shipping exceptions, inventory constraints, and escalations).  * Maintain SOPs, process maps, and continuous improvement initiatives to strengthen service levels, accuracy, and compliance.   * Partner with Supply Chain and Quality to manage inventory visibility, product release status, recalls, returns, and product integrity requirements.   Partner and Contract Management   * Primary relationship manager for 3PL, specialty distributors, and network specialty pharmacies.  * Negotiate and govern distribution service agreements and SOWs; define KPIs/SLAs; lead QBRs and corrective action plans in partnership with Legal, Compliance, and Finance.   Trade Compliance, Data, and Governance   * Own customer master data and class-of-trade governance, including evaluation and approval of new customer requests.  * Ensure compliant distribution operations in accordance with DSCSA, government programs (e.g., 340B, Medicare/Medicaid), and company policies.  * Oversee distribution data flows and communications (specialty pharmacy data, inventory/order reporting, pricing compendia, return goods policy updates) to enable accurate analytics.  * Leverage and partner with Commercial Operations/IT to optimize Immunome’s commercial systems ecosystem—including the selected data aggregator(s), data warehouse, and analytics/BI tools—to integrate and govern channel data (3PL, specialty distributor, and specialty pharmacy feeds), track and visualize KPIs/SLAs, and generate actionable insights (dashboards, scorecards, alerts) that enable proactive performance management and coordinated engagement with field team members and channel customers.   Leadership and Cross-Functional Collaboration   * Establish long-term vision and operational roadmap for Immunome’s trade and distribution as the portfolio expands.  Build, develop and scale internal and external capabilities to support future commercial growth.    * Collaborate with Supply Chain, Finance, Managed Markets, Reimbursement, Patient Services/HUB, IT, Marketing, and Sales/Sales Ops to align channel strategy and execution.   * Support channel financial processes (fees, reserves, and reconciliations) and provide insights on performance and operational opportunities.   * Lead and mentor team members/contractors as appropriate; operate comfortably in a fast-paced startup environment.   Qualifications * Bachelor’s degree required; advanced degree preferred.  * 10+ years of experience in trade/channel, distribution, or commercial operations in biopharma, with specialty pharmaceuticals experience, or equivalent. * Experience building and managing specialty distribution networks (3PL, specialty distributors, and specialty pharmacies); oncology and/or oral oncology preferred.   * Strong contract negotiation and partner governance skills; able to interpret common distribution terms and service-level clauses.   * Working knowledge of U.S. distribution channels and government programs (e.g., 340B, Medicare, Medicaid), and experience partnering with Market Access and Patient Services teams.   * Demonstrated ability to track and improve channel performance through metrics and data (service levels, inventory, order status, specialty pharmacy data).   * Technology-savvy and comfortable with Excel/PowerPoint and common channel systems (e.g., ERP, WMS/3PL, data aggregators).   * Ability to travel as needed to support partner governance (anticipated up to ~25%).   Knowledge and Skills * Ability to build productive relationships with diverse internal and external stakeholders.  * Strong organizational, planning, and strategic thinking skills; manage competing priorities with urgency and attention to detail.  * Data-driven problem solver; comfortable navigating ambiguity and complexity.   * Excellent written, verbal, and presentation skills; able to lead business reviews with senior audiences.   * Hands-on, customer-oriented approach to issue resolution and operational execution.   * High integrity and commitment to compliance; escalates appropriately when needed.  * Effective leader and coach; able to influence without authority and align cross-functional teams.   Washington State Pay Range $221,551—$258,543 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. E-Verify Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster [https://immunome.box.com/s/bopxukipfidxjscs4bjxt75f90bvpppk] | Right to Work Poster (English) [https://immunome.box.com/s/r51g9subw1wqni9xkutbl6up635sjr8e] | Right to Work Poster (Spanish) [https://immunome.box.com/s/r3ekbimwh988my9vzl76tnlbg60zvh9u].

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Associate Director, Clinical Quality Management serves as the central Risk-Based Quality Management (RBQM) Lead for Clinical Operations, responsible for enterprise-wide, proactive risk management across clinical trials. This role owns the end-to-end RBQM framework, including risk identification, assessment, mitigation, centralized monitoring, lessons learned, and maintenance of a clinical risk library, ensuring risks are managed consistently and intelligently across studies, programs, vendors, and regions. The role partners cross-functionally to embed risk-based decision-making into study design, execution, oversight, and continuous improvement, in alignment with ICH E6 (R3), GCP, and global regulatory expectations. Essential Functions: Risk-Based Quality Management (RBQM) Leadership •    Lead the design, implementation, and continuous evolution of a holistic RBQM framework across Clinical Operations, aligned with ICH E6 (R3) and regulatory guidance. •    Serve as the central RBQM authority ensuring consistent risk management approaches across trials, programs, regions, and vendors. •    Integrate RBQM principles into study planning, execution, oversight, and close-out activities. •    Provide expert oversight and guidance to study teams on study-level RBQM plans, ensuring alignment with enterprise risk strategy. Central Risk Identification, Monitoring & Mitigation •    Lead proactive, cross-study and cross-functional risk assessments to identify systemic, emerging, and study-specific risks. •    Define, standardize, and maintain Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) across trials. •    Oversee centralized risk monitoring and trending to enable early detection of critical risks. •    Partner with study teams to develop and oversee risk mitigation, contingency, and escalation plans, ensuring inspection Lessons  Learned & Risk Library Management (Core Ownership) •    Establish and maintain a centralized Clinical Risk Library, capturing: o    Known and emerging risks o    Root causes o    Mitigation strategies o    Effectiveness of controls •    Lead lessons learned activities across trials, audits, inspections, and CAPAs. •    Ensure lessons learned are: o    Systematically captured o    Analyzed for trends o    Fed back into RBQM planning, SOPs, training, and future studies •    Drive organizational learning by translating lessons learned into preventive, forward-looking risk controls.readiness. Quality Oversight & Regulatory Compliance •    Ensure clinical trial conduct complies with GCP, regulatory requirements, and company SOPs. •    Provide centralized quality oversight across trials, CROs, and vendors. •    Support audit and inspection readiness activities, including: o    Risk-based inspection preparation o    Impact assessments o    CAPA development and effectiveness checks Vendor & CRO Risk Oversight •    Design and implement risk-based oversight strategies for CROs and external vendors. •    Monitor vendor performance using quality metrics and risk indicators. •    Lead or support quality governance discussions with external partners. •    Ensure vendor-related risks are integrated into the central risk library and lessons learned framework. Data-Driven Quality & Continuous Improvement •    Leverage data analytics and centralized monitoring tools to enable real-time risk detection and decision-making. •    Generate enterprise-level risk trend reports and insights for senior leadership. •    Continuously refine RBQM methodologies based on data, inspection outcomes, and lessons learned. •    Champion a culture of proactive quality and continuous improvement across Clinical Operations. Cross-Functional Collaboration & RBQM Expertise •    Act as the RBQM Subject Matter Expert (SME) for Clinical Operations and Clinical Quality Compliance. •    Provide RBQM training and coaching to study teams and cross-functional stakeholders. •    Collaborate closely with Regulatory, Biostatistics, Data Science, QA, and Vendor Management teams to align risk strategies and metrics. •    Participate as an observing member on assigned study teams to provide real-time quality and risk support. SOP Management & Governance Support •    Partner with Document Control and SOP Administration teams to ensure RBQM and lessons learned are reflected in SOPs, WIs, and templates. •    Support governance activities, senior management reporting, and quality metrics standardization. •    Recommend and support implementation of corrective and preventive actions to protect system, process, and data integrity.provide real-time quality and risk support. Requirements: Education •    Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Public Health, or related field (required) •    Advanced degree in Clinical Research, Quality Management, Regulatory Affairs, or Data Science (preferred) Experience •    10+ years of experience in Clinical Operations, Clinical Quality, RBQM, or RBM •    Demonstrated experience leading enterprise or cross-study risk management frameworks •    Strong background in audit/inspection readiness, CAPA management, and vendor oversight •    Deep knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements Technical Skills •    Expertise with RBQM tools, centralized monitoring systems, and risk analytics •    Experience defining and using KRIs, QTLs, and quality metrics •    Familiarity with CTMS, eTMF, and data visualization tools (Spotfire, Tableau, Power BI) •    Exposure to AI or predictive analytics for quality monitoring (preferred) Working Conditions: Requires up to 25% domestic and international travel. May involve working outside of regular business hours to accommodate global time zones and project deadlines. The anticipated salary for this position will be $175,000 to $190,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: * 401K with company match * Annual Bonus Program (Sales Bonus for Sales Jobs) * Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days * Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) * HSA & FSA Programs * Well-Being and Work/Life Programs * Life & Disability Insurance * Concierge Services * Long Term Incentive Program (subject to job level and performance) * Pet Insurance * Tuition Assistance * Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.  Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. RECRUITMENT & STAFFING AGENCIES Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #LI-TT1 #Hybrid #Princeton