Full-Time
Director Clinical Development Systems
Immunome
201-500 employees
Antibody-based therapeutic discovery and development
Compensation Overview
$229.2k - $256.3k/yr
Bothell, WA, USA
In Person
Bachelor's
 Biology & Biotech (1) |
|---|
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- A bachelor's degree or equivalent experience with 12 or more years in technology leadership, clinical systems, business analysis, product ownership, clinical operations technology, or technology program leadership within the biotechnology or pharmaceutical industry; alternatively, a higher degree with 10 or more years of relevant experience.
- Experience leading technology solutions, enterprise platforms, or technology portfolios including GxP systems.
- Experience implementing and optimizing Clinical Development capabilities, particularly electronic Trial Master File and Clinical Trial Management System implementations and related integrations.
- Experience delivering dashboards, predictive insights, automation, and decision-support tools.
- Experience supporting internal audits, regulatory inspections, inspection-readiness activities, corrective and preventive actions, and evidence preparation for validated clinical systems.
- Experience integrating clinical systems such as Clinical Trial Management Systems, electronic Trial Master Files, electronic data capture, safety, regulatory, site payments, study start-up, data warehouse, analytics, or reporting platforms.
- Strong stakeholder management, communication, and influencing skills across business, technical, quality, and vendor audiences, including senior leadership.
- Ability to translate business needs into technology strategies, business cases, process improvements, and measurable outcomes.
- Financial acumen for technology portfolio leadership, including budget planning, investment prioritization, forecasting, and value realization.
- High degree of domain knowledge of clinical development and clinical trial operations.
- Expertise in delivering technology programs using Agile, product management, business analysis, business process analysis, and hybrid delivery methodologies.
- Deep understanding of the system development life cycle, computer system validation, data integrity, audit trails, electronic records and electronic signatures, and GxP, FDA, and ICH-regulated system implementation practices.
- Ability to lead through ambiguity, influence without direct authority, develop talent, and deliver measurable business impact with professionalism, adaptability, and accountability.
- Serve as a clinical systems leader for the Development function, providing operational input on technology strategy, enterprise platforms, delivery options, and vendor solutions.
- Develop and maintain the multi-year systems roadmap, aligning systems investments to business priorities, regulatory compliance, patient impact, and measurable value.
- Recommend and establish governance forums for clinical systems programs, contributing to prioritization, scope and risk management, adoption, and sustainment.
- Champion artificial intelligence-enabled dashboards and advanced analytics that provide actionable insights into portfolio health, site performance, monitoring quality, Trial Master File health, issue resolution, and operational risk.
- Manage business cases, budgets, vendor delivery, strategic sourcing inputs, and value realization for the Clinical Development Systems portfolio.
- Lead cross-functional planning and delivery of electronic Trial Master File and Clinical Trial Management System implementation and modernization, including business process design, configuration, data migration, integration validation, training, adoption, and change management.
- Deliver a connected clinical operations ecosystem improving visibility across studies and spanning study start-up, enrollment, monitoring, milestones, protocol deviations, Trial Master File health, inspection readiness, and closeout.
- Partner with data and analytics leaders to define trusted key performance indicators, data sources, quality standards, access controls, reporting needs, and scalable dashboards for executive, functional, study, and operational teams.
- Identify and sponsor opportunities to simplify manual tracking, reduce duplicate data entry, automate processes, and strengthen data integrity.
- Lead vendor and platform selection, including requests for proposals, systems evaluations, and business case development.
- Oversee day-to-day management of vendors, ensuring compliance with contractual obligations, timelines, and performance metrics.
- Ensure adherence to ICH Good Clinical Practice, FDA, EMA, and global regulatory requirements.
- Partner with Quality Assurance on system validation, inspection readiness, audits and regulatory inspections, and corrective actions.
- Drive operational excellence to ensure data integrity.
- Maintain financial oversight of Clinical Development Systems budgets and resource planning for a growing portfolio.
- Build, lead, and mentor a high-performing Clinical Development Systems team, including Business Analysts, Business Owners, and Systems Administrators.
- Provide direction and support to project teams, partner resources, and vendor teams supporting Development technology initiatives.
- Promote a culture of innovation, excellence, data integrity, inspection readiness, and continuous improvement.
Immunome identifies antibodies and their targets by studying the immune systems of patients who recover from diseases, to develop first-in-class therapeutics. Its platform analyzes immune responses to discover novel antibodies and their targets, which are then advanced through research and development in partnership with healthcare and medical research clients. The company’s products work by using antibodies discovered from patients’ immune systems to target diseases, potentially enabling new treatments across oncology and other areas. Immunome differentiates itself through a proprietary discovery platform that extracts clinically relevant antibodies from real patient immune responses, enabling collaborations and licensing deals rather than solely pursuing standalone drug sales. The goal is to bring new antibody therapies to patients by forming partnerships, licensing innovations, and eventually delivering approved therapies.
Company Size
201-500
Company Stage
IPO
Headquarters
Bothell, Washington
Founded
2008
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Simplify's Take
What believers are saying
- FDA set varegacestat's PDUFA date for April 28, 2027 after strong Phase 3 data.
- Cash and marketable securities totaled $520.0 million on June 30, 2026, funding into 2028.
- IM-1617's first patient dosing on June 11, 2026 expands multiple shots on goal.
What critics are saying
- IM-1617 faces AbbVie's ABBV-400 and Daiichi's crowded TOP1 ADC category by 2027.
- Immunome burned $120.3 million cash in first-half 2026, despite $520.0 million remaining.
- A varegacestat rejection would leave Immunome dependent on early-stage programs and recurring dilution.
What makes Immunome unique
- Varegacestat reached FDA acceptance in July 2026, anchoring Immunome's first near-term asset.
- IM-1617 targets an undisclosed RTK plus immune exclusion, a rare dual-mechanism ADC.
- IM-1021 and IM-3050 broaden the platform across ADC and radioligand modalities.
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Benefits
Health Insurance
Dental Insurance
Vision Insurance
401(k) Retirement Plan
401(k) Company Match
Unlimited Paid Time Off
Hybrid Work Options
Flexible Work Hours
Remote Work Options
Paid Vacation
Paid Holidays
Wellness Program
Mental Health Support
Conference Attendance Budget
Professional Development Budget
Stock Options
Company Equity
Phone/Internet Stipend
Home Office Stipend
Growth & Insights and Company News
6 month growth
↑ 21%1 year growth
↑ 21%2 year growth
↑ 9%Immunome reported Q2 2026 financial results, revealing a net loss of $73.1 million. The biotechnology company held $520.0 million in cash, cash equivalents and marketable securities as of 30 June, expected to fund operations into 2028. The FDA accepted Immunome's application for varegacestat, a desmoid tumour treatment, setting an approval decision date of 28 April 2027. Phase 3 trial data showed an 84% reduction in disease progression risk versus placebo. Research and development expenses totalled $59.9 million for the quarter, whilst general and administrative costs reached $18.3 million. Immunome is advancing three additional clinical-stage programmes, with first patients dosed in trials for IM-1617 and IM-3050. The company plans to submit investigational new drug applications for IM-1340 and IM-1335 by late 2026.
Immunome debuts first-in-class ADC targeting mystery immune-excluding receptor tyrosine kinase. June 12, 2026 Bothell, Washington-based Immunome, Inc. (Nasdaq: IMNM) has dosed the first patient in a Phase I first-in-human study of IM-1617, an antibody-drug conjugate directed at an undisclosed receptor tyrosine kinase (RTK) and armed with HC74, the company's proprietary topoisomerase I inhibitor payload. The trial's significance lies partly in its target biology: the RTK in question is described as promoting tumor cell survival while simultaneously mediating immune cell exclusion - a dual role that, if confirmed clinically, could position IM-1617 as relevant in immunologically cold tumors where checkpoint inhibitors have largely failed. The open-label, multicenter dose escalation and expansion study will enroll patients with advanced solid tumors, including colorectal cancer, non-small cell lung cancer, and breast cancer. Primary objectives cover safety, tolerability, and pharmacokinetics, with preliminary anti-tumor activity as an exploratory endpoint. Immunome has not disclosed enrollment targets or an anticipated completion date. Two additional ADC candidates - IM-1340 and IM-1335 - are expected to reach IND submission by mid- and late 2026, respectively, signaling broader platform ambitions beyond this single asset. The rationale for IM-1617 rests on a well-documented but therapeutically underexploited observation: certain receptor tyrosine kinases do not merely sustain tumor cell proliferation but actively remodel the tumor microenvironment to prevent T-cell infiltration. The TAM family RTKs - TYRO3, AXL, and MERTK - are the best-characterized examples, functioning as innate immune checkpoints that suppress dendritic cell and macrophage activity while driving tumor cell survival through PI3K/AKT and RAS/MAPK signaling. AXL in particular has been directly implicated in T-cell exclusion in breast cancer models, where high AXL expression correlated with complete absence of immune infiltration even following radiotherapy. This biology is directly relevant to the three indications Immunome has identified. Approximately 85% of colorectal cancers are microsatellite-stable and immunologically cold, explaining why PD-1/PD-L1 inhibitors have shown no benefit in this population. A comparable subset of non-small cell lung cancers and triple-negative breast cancers similarly fail to respond to immunotherapy, not because of absent antigenicity but because immune cells are physically excluded from the tumor parenchyma. An ADC targeting the RTK responsible for that exclusion could, in principle, simultaneously kill antigen-expressing tumor cells and relieve the suppressive barrier - potentially rendering surviving tumor tissue more susceptible to endogenous or therapeutically induced immune responses. Competitive positioning. The TOP1 inhibitor ADC space is crowded at the payload level but less so at the target level, where differentiation ultimately resides. Daiichi Sankyo and AstraZeneca's DXd platform dominates across HER2, HER3, and TROP2, with multiple Phase II and Phase III assets in NSCLC and breast cancer. AbbVie is advancing ABBV-400, a c-MET-targeted ADC with a proprietary TOP1 inhibitor payload, in NSCLC and colorectal cancer - indications that directly overlap with IM-1617's target population. Because IM-1617's RTK target remains undisclosed, precise competitive mapping is not possible, but the functional description - an RTK driving both survival signaling and immune exclusion - most closely resembles AXL or MERTK biology, neither of which currently has a clinical-stage ADC program of note. Immunome's broader pipeline context is relevant here. Varegacestat, the company's gamma secretase inhibitor for desmoid tumors, has an NDA filed with the US FDA following Phase III data showing 84% reduction in progression risk and a 56% objective response rate - substantially outperforming the current standard. That near-term commercial asset provides a degree of financial and strategic runway for the ADC platform to mature. IM-1021, the ROR1 ADC sharing the HC74 payload with IM-1617, will generate the first human pharmacokinetic and safety data for HC74, which will inform dose selection and linker optimization for subsequent programs including IM-1617. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/
Immunome, a biotechnology company developing targeted cancer therapies, reported first quarter 2026 financial results. The company had cash and cash equivalents of $582.7 million as of 31 March, expected to fund operations into 2028. The company submitted a New Drug Application to the US FDA in April 2026 for varegacestat, a treatment for adults with desmoid tumours. Immunome plans to submit a Marketing Authorisation Application to the European Medicines Agency by year-end 2026. Research and development expenses for the quarter were $46.4 million, whilst general and administrative expenses totalled $13.0 million. Immunome reported a net loss of $53.8 million for the quarter. The company is advancing multiple programmes, including Phase 1 trials for IM-1021 and IM-3050, and recently received IND clearance for IM-1617.
Immunome's Chief Scientific Officer Jack Higgins sold 9,438 shares on 2 April for $204,238, reducing his direct holdings by 30% to 22,000 shares. The sale was executed under a pre-arranged Rule 10b5-1 trading plan established in December 2025 for financial diversification. The transaction comes as the clinical-stage biotechnology company approaches a significant milestone: its lead candidate varegacestat met the primary endpoint in a Phase 3 trial in December 2025, with an FDA submission planned for the second quarter of 2026. Immunome expects three additional investigational new drug applications and early data from IM-1021 across 2026. The company's stock has risen 250% over the past year, bringing its market capitalisation to $2.40 billion.
Immunome has reported a reduced full-year net loss of $212.39 million for 2025 and filed a $156.03 million common stock shelf registration linked to an employee stock option plan offering. The biotechnology company also updated investors on progress in its oncology pipeline. The company plans to file a New Drug Application for varegacestat following positive Phase 3 data, with multiple solid tumour investigational new drug applications also in development. However, Immunome remains deeply unprofitable despite the narrower losses. The shelf registration raises concerns about potential equity dilution and ownership overhang. Fair value estimates from analysts vary widely, ranging from approximately $29 to over $215 per share, reflecting significant uncertainty around the company's prospects as it advances its high-risk oncology platform.