S

Systimmune

Develops bispecific antibodies and ADCs

Global Director - Clinical Project Management

Full-TimeUpdated on 10/16/2026
$180k - $230k/yr
Expert
Bachelor's, Master's
Princeton, NJ, USA
HybridHybrid onsite work in Princeton; overnight travel is approximately 25%.
Biology & BiotechClinical Research Operations

About the job

Requirements
  • A bachelor's degree in Life Sciences, Nursing, or a related field.
  • At least 10 years of experience in clinical trial management, including at least 5 years in a direct line management role.
  • Strong understanding of Good Clinical Practice and regulatory requirements.
  • Organizational and project management skills.
  • Ability to lead cross-functional teams and manage multiple priorities.
  • Communication and interpersonal skills.
  • Ability to work collaboratively in a team-oriented environment.
  • Flexibility and adaptability to changing priorities and workload.
Responsibilities
  • Oversee the planning and execution of global clinical trials.
  • Develop and implement study protocols, timelines, and budgets.
  • Manage clinical trial operations, including site selection, initiation, monitoring, and closeout.
  • Ensure compliance with Good Clinical Practice and regulatory guidelines.
  • Coordinate with investigators, vendors, regulatory bodies, cross-functional teams, and external partners involved in trials.
  • Monitor trial progress and manage data collection to ensure accuracy and integrity.
  • Identify and mitigate project risks.
  • Oversee a team of regional CPMs, CRAs, and CTAs.
  • Ensure regulatory documents are prepared and submitted in compliance with local regulatory standards and maintained according to Good Clinical Practice.
  • Conduct regular meetings with study teams and provide updates to stakeholders.
  • Support the development of internal process initiatives and standard operating procedures.
  • Oversee vendors supporting trial execution.
Desired Qualifications
  • A master's degree in a related field or clinical research certification, such as ACRP or SOCRA.
  • Experience with electronic data capture systems and clinical trial management software.
  • Prior experience running or supporting oncology clinical trials.
  • Previous experience in a sponsor or contract research organization environment.

About the company

S

Systimmune

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Website

Systimmune is a biopharmaceutical company that develops antibody-based cancer therapies, including bispecific and trispecific antibodies and antibody-drug conjugates (ADCs). These products are designed to act on the solid tumor micro-environment to directly attack tumors and/or to activate the immune system to fight cancer. The company uses multiple immuno-oncology platforms and experienced scientists to create biologics that intervene in the tumor environment in systematic ways. Compared with competitors, Systimmune emphasizes integrating several antibody-based modalities (bispecifics, trispecifics, and ADCs) and a deep focus on the solid tumor micro-environment, aiming to translate biological insight into targeted, immune-engaging therapies. The goal is to produce biologics that effectively modulate the tumor environment and mobilize the body's own immune response to destroy cancer cells.

Company Size

11-50

Company Stage

N/A

Total Funding

N/A

Headquarters

Redmond, Washington

Founded

2014

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Simplify's Take

What believers are saying

  • June 2, 2026 Phase III data showed overall survival gains in TNBC and ESCC.
  • July 17, 2026 brought a second NMPA approval for recurrent metastatic esophageal squamous cell carcinoma.
  • May 21, 2026 ASCO presentations expanded BL-M14D1, T-Bren, and BL-M05D1 beyond iza-bren.

What critics are saying

  • SystImmune still depends on China data; BMS ex-China commercialization remains unproven.
  • June 1, 2026 BL-M14D1 reported one treatment-related death and grade-3 interstitial lung disease.
  • If U.S. or China regulators reject iza-bren, SystImmune loses its sole near-term value driver.

What makes Systimmune unique

  • Iza-bren became the world’s first bispecific ADC approved in China on June 22, 2026.
  • Its EGFR×HER3 design and brengitecan platform support multiple late-stage tumor programs.
  • Bristol Myers Squibb funds ex-China development, validating SystImmune’s platform and reach.

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Benefits

  • Health Insurance
  • Dental Insurance
  • Vision Insurance
  • Disability Insurance
  • 401(k) Retirement Plan
  • 401(k) Company Match
  • Paid Vacation
  • Paid Sick Leave
  • Paid Holidays

Company News

SystImmune
Sep 12th, 2026
SystImmune

News and Publications > SystImmune, Inc. to Present New Global Data on Iza-bren (izalontamab brengitecan) in EGFR-mutated Non-Small Cell Lung Cancer at WCLC Congress 2026 SystImmune, Inc. to Present New Global Data on Iza-bren (izalontamab brengitecan) in EGFR-mutated Non-Small Cell Lung Cancer at WCLC Congress 2026 September 12th, 2026 Redmond, Washington - New global Phase 1 data from a randomized dose-expansion cohort of iza-bren in previously treated EGFR-mutated metastatic NSCLC demonstrate promising antitumor activity and a tolerable safety profile, supporting selection of 2.5 mg/kg D1D8 Q3W as the recommended Phase 3 dose Redmond, WA - September 12, 2026 - SystImmune, Inc. (SystImmune), a clinical-stage biotechnology company, today announced an abstract for iza-bren (izalontamab brengitecan), a potentially first-in-class EGFRxHER3 bispecific antibody drug conjugate (ADC), will be presented in an oral presentation at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC) taking place September 12 - 15 in Seoul, South Korea. Iza-bren is being developed under a license and collaboration agreement by and between SystImmune and Bristol Myers Squibb. The global Phase 1 data being presented at WCLC 2026 evaluated iza-bren in a randomized expansion cohort across three dose levels in patients with EGFR-mutated metastatic NSCLC who had previously received a third-generation EGFR inhibitor. The randomized dose-expansion results demonstrate promising clinical activity, with higher efficacy observed at the 2.5 mg/kg dose level with a manageable safety profile, and support 2.5 mg/kg D1D8 Q3W as the recommended Phase 3 dose for IZABRIGHT-Lung01, the global registrational study of iza-bren in EGFR-mutated NSCLC following progression on a third-generation EGFR inhibitor. The data further demonstrated the consistent efficacy and safety profile in a global population as shown previously in Chinese patients. These findings further advance the global development of iza-bren in EGFR-mutated NSCLC and build upon the clinical activity reported across multiple tumor types at prior international medical meetings. "The data being presented at WCLC provide important insights into the clinical profile of iza-bren in global patients with previously treated EGFR-mutated metastatic NSCLC," said Jonathan Cheng, M.D., Chief Medical Officer of SystImmune. "We are encouraged by the promising antitumor activity observed in this randomized dose-expansion cohort, including the increased efficacy observed at the 2.5 mg/kg dose level. Together with the safety and pharmacokinetic findings, these results support 2.5 mg/kg D1D8 Q3W as the recommended Phase 3 dose and represent an important step forward as we advance the global registrational study, IZABRIGHT-Lung01, in patients with EGFR-mutated NSCLC following progression on a third-generation EGFR inhibitor." Details of the presentations at WCLC are below: Phase 1 Global Study of Iza-bren in Patients with Metastatic EGFR-mutated NSCLC: Results of the Randomized Dose Expansion Cohort Session Title: OA10 - Novel Antibodies and ADCs - Are They HERalding New Benchmarks? Presentation: OA10.01 Speaker: Alexander Spira (United States) Session Date & Time: Monday Sep 14, 2026 12:00 PM - 1:15 PM (KST) About iza-bren Iza-bren (BL-B01D1) is a bispecific antibody-drug conjugate (ADC) that targets both EGFR and HER3, which are highly expressed in various epithelial cancers and are known to be associated with cancer cell proliferation and survival. Iza-bren's dual mechanism of action blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. In addition, upon antibody mediated internalization, iza-bren's therapeutic novel Topo1i payload is released, causing cytotoxic stress that leads to cancer cell death. Iza-bren is being developed under a license and collaboration agreement by and between SystImmune and Bristol Myers Squibb. About SystImmune. SystImmune is a clinical-stage biopharmaceutical company located in Redmond, WA. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has several assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development. Forward-Looking Statements This press release contains forward-looking statements, including statements regarding the potential clinical benefits of iza-bren, the timing and outcomes of regulatory interactions, and the future development and commercialization of iza-bren. Forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially. SystImmune undertakes no obligation to update any forward-looking statements contained herein, except as required by law. Media Contact SystImmune, Inc.

PR Newswire
Jul 17th, 2026
China approves iza-bren for recurrent or metastatic oesophageal squamous cell carcinoma

SystImmune announced that China's National Medical Products Administration has approved iza-bren for treating adult patients with recurrent or metastatic esophageal squamous cell carcinoma after prior platinum-based chemotherapy and PD-1/PD-L1 inhibitor therapy. This is the second approved indication for iza-bren in China, following its recent approval for nasopharyngeal carcinoma. The approval was based on the PANKU-Esophagus01 study, which enrolled 497 patients across 80 centres in China. The trial met both primary endpoints, showing median overall survival of 9.8 months with iza-bren versus 7.2 months with chemotherapy, and median progression-free survival of 4.2 months versus 2.0 months. Iza-bren is a bispecific antibody-drug conjugate targeting EGFR and HER3. It is currently being evaluated in multiple global clinical studies across several solid tumour types.

Yahoo Finance
Jun 22nd, 2026
China approves iza-bren, world's first bispecific ADC, for metastatic nasopharyngeal carcinoma

SystImmune's parent company, Sichuan Biokin Pharmaceutical, has received China's NMPA approval for iza-bren (BL-B01D1) to treat recurrent or metastatic nasopharyngeal carcinoma in patients who progressed after platinum-based chemotherapy and PD-1/PD-L1 inhibitor therapy. This marks the first regulatory approval globally for iza-bren and the first bispecific antibody-drug conjugate (ADC) approval of any kind worldwide. The approval follows results from the pivotal Phase III trial, where iza-bren demonstrated a confirmed objective response rate of 54.6% versus 27.0% for chemotherapy. Median progression-free survival was 8.38 months compared to 4.34 months for chemotherapy. Iza-bren is a first-in-class EGFR×HER3 bispecific ADC developed using SystImmune's proprietary platform.

WOBN
Jun 9th, 2026
ASCO: Bristol Myers' $800M bispecific ADC aces China breast cancer study, putting TROP2 drugs on notice.

ASCO: Bristol Myers' $800M bispecific ADC aces China breast cancer study, putting TROP2 drugs on notice. June 9, 2026 WOBN news, syndication comments off on ASCO: Bristol Myers' $800M bispecific ADC aces China breast cancer study, putting TROP2 drugs on notice. A first-in-class bispecific antibody-drug conjugate that Bristol Myers Squibb licensed from SystImmune, in a $800M deal has shown strong phase 3 breast cancer results from China. The findings suggest the therapy as a potential competitor in the TROP2 treatment landscape while underscoring growing interest in next-generation ADCs.

SystImmune
Jun 1st, 2026
SystImmune

News and Publications > SystImmune Reports Phase 1 Data for BL-M14D1 Demonstrating Promising Activity in Small-Cell Lung Cancer at ASCO SystImmune Reports Phase 1 Data for BL-M14D1 Demonstrating Promising Activity in Small-Cell Lung Cancer at ASCO June 1st, 2026 Redmond, Washington June 1, 2026 Redmond, WA - Jun 1, 2026 - SystImmune, Inc., a clinical-stage biotechnology company, today announced the oral presentation of Phase 1 data for BL-M14D1 in patients with small-cell lung cancer (SCLC), neuroendocrine carcinoma (NEC), and other solid tumors (BL-M14D1-101, NCT06505824) at the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting in Chicago. BL-M14D1 is a DLL3 targeting antibody drug conjugate being developed globally by SystImmune, a subsidiary of Biokin. This study evaluated the safety and efficacy of BL-M14D1 in Chinese patients with advanced SCLC, NEC, and other solid tumors. As of the November 30, 2025 data cut-off, BL-M14D1 demonstrated: - Promising antitumor activity in heavily pre-treated patients across multiple tumor types, including SCLC and other NECs - Manageable safety profile, with hematologic adverse events managed with standard supportive care A total of 127 patients with advanced solid tumors were treated, including 87 with SCLC and 40 with NEC. Most patients were heavily pre-treated. The most common adverse events were hematologic, including neutropenia, which were generally manageable and infrequently led to dose reductions or serious complications. The safety profile is consistent with other brengitecan based topo1 ADCs. One case of grade 3 interstitial lung disease was seen, and one treatment related death was reported. Among patients with SCLC treated at 4.0 mg/kg D1Q3W, the confirmed objective response rate was 62% (21 of 34 patients), with a median progression-free survival of 7.2 months. Based on these results, SystImmune plans to initiate a global registrational study in first-line extensive-stage SCLC. "These initial Phase 1 results for BL-M14D1 demonstrate compelling anti-tumor activity, including a 62% confirmed response rate and encouraging durability, in heavily pre-treated patients with small-cell lung cancer," said Jonathan Cheng, M.D., Chief Medical Officer of SystImmune. "Given the significant unmet need in this population, we believe these data support the potential for BL-M14D1 to become an important new treatment option, and we are rapidly advancing the program into global registrational studies in the first-line setting." About the BL-M14D1-101 Phase I clinical trial BL-M14D1-101 (NCT06505824) is a multi-center, Phase I study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M14D1 in locally advanced or metastatic solid tumors. The study is being conducted in three parts (dose escalation, dose finding, and dose expansion) with patients being dosed on Day 1 of a continuous 21-day treatment cycle (D1Q3W). In the dose escalation and dose expansion phase, patients were treated with BL-M14D1 at 0.66, 2.0, 3.5, 4.0, 4.5, 5.0, and 6.0 mg/kg. In the dose expansion phase, SCLC and NEC patients were treated at 4.0 and 4.5mg/kg D1Q3W. The primary endpoint includes safety. Secondary endpoints include objective response rate (ORR) by RECIST 1.1 criteria, duration of response (DoR), disease control rate (DCR), and PK analysis. About BL-M14D1 SystImmune is advancing a portfolio of next-generation antibody-drug conjugates (ADCs) built on its proprietary brengitecan platform, which utilizes a potent topoisomerase I inhibitor payload designed for targeted delivery to tumor cells. The clinical progress of izalontamab brengitecan (iza-bren) provides initial validation of this platform's potential to deliver meaningful anti-tumor activity across multiple cancer types. BL-M14D1 targets DLL3, which is highly expressed in small-cell lung cancer and neuroendocrine tumors, facilitating selective delivery of the brengitecan payload to DLL3-positive tumor cells. About SystImmune. SystImmune is a clinical-stage biopharmaceutical company located in Redmond, WA. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has several assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development. Forward-Looking Statements This press release contains forward-looking statements, including statements regarding the potential clinical benefits of iza-bren, the timing and outcomes of regulatory interactions, and the future development and commercialization of iza-bren. Forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially. SystImmune undertakes no obligation to update any forward-looking statements contained herein, except as required by law. Media Contact SystImmune, Inc.