A

Arcus

Develops combination cancer therapies in oncology

Senior Manager - IT Qualification & Validation

Full-TimeUpdated on 10/2/2026
$175k - $185k/yr+ Performance-based bonus + Stock programs
Expert
Bachelor's
Remote in USA+2 moreMore locations: Brisbane, CA, USA | Hayward, CA, USA
RemoteRemote employees must work Pacific Time business hours, 9 AM to 5 PM PT.

About the job

Requirements
  • Bachelor of Science degree in Computer Science, Life Sciences, Engineering, or a similar discipline, or equivalent experience.
  • 10+ years of experience in computer system validation activities in the pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
  • Demonstrated senior-level, hands-on experience qualifying and validating GxP-relevant IT infrastructure and enterprise systems, including cloud environments such as Amazon Web Services, identity and access management systems such as Okta, directory services such as Active Directory, and dedicated computing environments.
  • Strong validation experience with infrastructure-adjacent and analytical applications, such as RStudio/Posit, SAS platforms, Pinnacle 21, or similar regulated systems.
  • Experience using Veeva Vault Quality, including Veeva Validation Management.
  • Proven experience supporting Deviations, Investigations, Change Controls, and CAPA actions within a regulated environment.
  • Advanced working knowledge of GxP regulations, System Life Cycles, risk-based validation such as GAMP 5, 21 CFR Part 11, Annex 11, and ALCOA+ data integrity principles.
  • Strong leadership skills, with the ability to influence, mentor, and guide cross-functional teams.
  • Strong project-management, planning, organizing, and execution skills, including the ability to manage multiple priorities and meet deadlines.
  • Ability to work independently while proactively identifying risks, gaps, and improvement opportunities.
  • Ability to develop and implement creative solutions to improve processes.
  • Must support Pacific Time business hours, 9 AM to 5 PM PT.
  • Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials and a computer screen; hearing and speech to communicate in person, before groups, and over the telephone; and the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds.
Responsibilities
  • Lead, mentor, and manage contract CSV resources, including assigning projects, obtaining status reports, providing technical and procedural guidance, and approving timesheets.
  • Plan and organize validation activities across cross-functional groups and provide and maintain status updates for day-to-day operations and project work.
  • Collaborate with IT leadership and Quality to define resource allocation, validation scope, and validation timelines.
  • Generate, obtain approvals for, and execute validation deliverables for computerized systems and supporting infrastructure, including Validation Plans, Test Plans, User and Functional Requirements, IQ/OQ/PQ test scripts, Traceability Matrices, Test Summary Reports, and Validation Summary Reports.
  • Lead and execute senior-level infrastructure qualification and validation activities for GxP-relevant systems, including Okta Single Sign-On, Active Directory, Amazon Web Services, dedicated computing environments, and infrastructure-related GxP applications.
  • Provide validation oversight and support for infrastructure-related and analytical platforms, including RStudio/Posit, SAS environments, and Pinnacle 21.
  • Perform hands-on qualification and validation testing, including authoring and execution within Veeva Validation Management.
  • Support and, where required, lead validation activities within Veeva Vault Quality, including test script authoring and execution and lifecycle maintenance.
  • Support change control activities to ensure validation impact assessments are performed compliantly and regulated systems remain in a validated state.
  • Support Deviation, Investigation, and CAPA activities, including impact assessments, root cause analysis, remediation planning, and documentation.
  • Work with Quality Assurance to investigate system issues, perform root cause analysis, and implement solutions.
  • Develop and enhance the validation program to maintain alignment with regulatory expectations.
  • Conduct periodic reviews of GxP computerized systems and maintain the supporting process to ensure systems remain in a validated, compliant state in accordance with applicable regulations and standard operating procedures.
  • Perform gap assessments and remediation activities as needed.
  • Ensure timely, efficient, and effective communication and interaction with internal GxP partners and external contract providers.
Desired Qualifications
  • 3+ years in a leadership or people-management capacity, including management of contract CSV personnel.
  • Experience validating Quality, Regulatory, Clinical, or Analytical systems in a pharmaceutical or biotech environment.
  • Experience qualifying and validating enterprise IT infrastructure in cloud-based and hybrid environments.
  • Experience validating Veeva Vault applications.
  • ASQ certification such as CQE or CQM.

About the company

Arcus Biosciences develops cancer medicines by designing and advancing combination therapies. Its work centers on oncology, with drug candidates tested through clinical trials to evaluate safety and efficacy, and partnerships, licensing deals, and eventual sales to bring therapies to patients. The company’s products are built to work in combination with other treatments to improve cancer outcomes, and tested in trials to determine optimal dosing and synergistic effects. Arcus differentiates itself through a focus on combination strategies and collaboration with partners, research institutions, and healthcare providers, aiming to advance science-led cancer treatments. Its goal is to improve the lives of cancer patients and move toward potential cures by advancing new combination therapies backed by rigorous research and development.

Company Size

501-1,000

Company Stage

IPO

Headquarters

Hayward, California

Founded

2015

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Simplify's Take

What believers are saying

  • Q2 2026 revenue reached $41 million; Arcus raised full-year guidance to $65-$75 million.
  • PEAK-1 enrollment stays on track for year-end 2026, setting up first registrational casdatifan readout.
  • TD Cowen initiated Buy on September 16, 2026, citing casdatifan's superior RCC profile.

What critics are saying

  • Gilead lets option rights lapse July 14, 2026, shrinking Arcus's pipeline and cash backstop.
  • Arcus stopped STAR-121 and PACIFIC-8 in 2026, proving domvanalimab can't clear Phase 3 futility.
  • Casdatifan remains unapproved; PEAK-1 failure would leave Arcus without a growth engine.

What makes Arcus unique

  • Casdatifan targets HIF-2α in ccRCC, backed by 15.1-month PFS and 45% response.
  • Arcus keeps full global rights outside Taiho territories, preserving upside from approvals.
  • Partnership model with BMS, Summit, and Gilead broadens trial execution without surrendering assets.

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Benefits

Remote Work Options

Stock Options

Performance Bonus

Growth & Insights and Company News

Headcount

6 month growth

↑ 0%

1 year growth

↑ 0%

2 year growth

↑ 0%
Investing.com
Sep 16th, 2026
Why is Arcus Biosciences stock rallying today?

Why is Arcus Biosciences stock rallying today? Published Sep 16, 2026, 11:21 AM (C) Pavlo Gonchar / SOPA Images/Sipa via Reuters Connect Investing.com - Arcus Biosciences stock rose 3.4% in morning trading after TD Cowen initiated coverage with a Buy rating, citing the superior clinical profile of casdatifan, the company's investigational HIF-2α inhibitor, in the treatment of renal cell carcinoma. Analyst Tara Bancroft argued that casdatifan's 15.1-month median progression-free survival compares favorably to the 5.6 months seen with Welireg, the current leading HIF-2α inhibitor, positioning casdatifan as a potential best-in-class therapy in a market estimated to exceed $10 billion. The initiation arrives against a backdrop of steadily rising analyst sentiment toward RCUS. Truist Securities raised its price target to $40 from $35 as recently as September 8, and the stock now carries a consensus "Moderate Buy" rating across thirteen covering brokerages. Adding to the fundamental case, Arcus reported Q2 2026 revenue of $41 million - nearly double the Street's $21.98 million estimate - demonstrating that its collaboration agreements are generating meaningful near-term cash flow alongside its pipeline progress. The broader market provided a constructive environment for the move, with the S&P 500 edging up 0.4% and the NASDAQ advancing 0.8%, creating a risk-on tone that tends to lift clinical-stage biotech names. Investors are also positioning ahead of an anticipated October data readout for casdatifan combined with cabozantinib in second-line RCC, a potential near-term catalyst that TD Cowen flagged as a key inflection point for the stock. Taken together, a high-profile analyst initiation with a bullish thesis, a string of positive pipeline and financial developments, and a supportive broader market combined to push RCUS shares to an intraday high of $25.18 today, well above the prior close of $24.32 and meaningfully above the stock's 52-week low of $11.68, reflecting how dramatically sentiment has shifted around the casdatifan story. -33.48 (-0.44%) Closed · 15:59:58 Spot the trade on RCUS before it happens. Most traders know the market. The hard part is the moment - which stock, right now, at what price. Chart analysis handles that. Our Vision AI scans your charts, spots the pattern before it plays out, and hands you the complete setup: entry, exit, done in under 60 seconds. Investors are already reporting a high accuracy rate, even on penny stocks.

San Francisco Biotechnology Network
Jul 22nd, 2026
Arcus Biosciences and Summit Therapeutics enter into clinical trial collaboration to evaluate casdatifan combined with ivonescimab in kidney cancer.

Arcus Biosciences and Summit Therapeutics enter into clinical trial collaboration to evaluate casdatifan combined with ivonescimab in kidney cancer. July 22, 2026 san francisco biotechnology network news news, syndication comments off on arcus Biosciences and Summit Therapeutics enter into clinical trial collaboration to evaluate casdatifan combined with ivonescimab in kidney cancer. HAYWARD, Calif. & MIAMI-(BUSINESS WIRE) - - $SMMT-Arcus Biosciences, Inc. (NYSE: RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer and inflammatory and autoimmune diseases, and Summit Therapeutics Inc. (Nasdaq: SMMT), a biopharmaceutical company focused on patient-friendly oncology therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical ne Click here to view original post Discover more Geographic Reference Social Networks

Arcus Biosciences
Jun 3rd, 2026
Arcus Biosciences announces clinical trial collaboration and supply agreement to evaluate casdatifan in combination with PD-L1/VEGF-A bispecific immunomodulator to treat Kidney Cancer.

Arcus Biosciences announces clinical trial collaboration and supply agreement to evaluate casdatifan in combination with PD-L1/VEGF-A bispecific immunomodulator to treat Kidney Cancer. June 3, 2026 * This collaboration aims to develop a novel treatment regimen that delivers more sustained tumor control in kidney cancer, a cancer of high unmet medical need HAYWARD, Calif.-(BUSINESS WIRE)- Arcus Biosciences, Inc. (NYSE: RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer and inflammatory and autoimmune diseases, today announced a clinical trial collaboration and supply agreement with Bristol Myers Squibb (NYSE: BMY, "BMS"). Under the agreement, Arcus will supply casdatifan, the company's investigational small-molecule HIF-2a inhibitor, to be evaluated as part of the BMS-sponsored Phase 1/2 ROSETTA RCC-208 clinical trial. This trial evaluates pumitamig (BNT327/BMS986545), an investigational PD-L1/VEGF-A bispecific antibody, being jointly developed by BioNTech and Bristol Myers Squibb, alone or in combination with other potential treatment options in advanced renal cell carcinoma (RCC). As part of this clinical trial collaboration, casdatifan combinations will be added as two new arms of ROSETTA RCC-208. Each company will retain development and commercial rights to their respective assets, and the agreement is mutually non-exclusive. "We believe casdatifan can transform the treatment paradigm in kidney cancer, and our development strategy is designed to generate evidence needed to establish casdatifan as a backbone therapy so that every patient has the opportunity to benefit from casdatifan across each line of therapy," said Terry Rosen, Ph.D., chief executive officer of Arcus. "HIF-2a inhibition, PD-L1 and VEGF-A blockade are validated mechanisms in the treatment of kidney cancer with a strong biologic rationale for combination. This strategic collaboration with BMS is a top priority for Arcus in order to potentially deliver an additional effective TKI-free option in the first-line setting." This collaboration is part of Arcus's holistic development strategy that is intended to provide physicians and patients with: 1) a casdatifan-based and only HIF-2a inhibitor-inclusive TKI-sparing first-line treatment; 2) a casdatifan-based TKI-inclusive first-line regimen; 3) a second-line HIF-2a inhibitor treatment that builds on the second-line standard-of-care TKI, cabozantinib; and 4) a late-line therapy that has been clinically validated to also provide benefit in patients previously treated with a HIF-2a inhibitor-based therapy. About Casdatifan (AB521) Casdatifan is a small-molecule inhibitor of hypoxia-inducible factor 2-alpha (HIF-2a), a master switch that turns on hundreds of genes in response to low oxygen levels. In a majority of people with the most common form of kidney cancer (clear cell renal cell carcinoma; ccRCC), genetic anomalies result in the dysregulation of this master switch and transformation of normal kidney cells into cancerous ones. Casdatifan was designed to provide deep and durable inhibition of the HIF-2a pathway. Early clinical studies have shown high response rates and a low primary progression rate relative to clinical benchmarks, warranting further investigation in late-stage studies. Casdatifan, which is administered in pill form once daily, has a safety profile that allows it to be investigated in combination with other treatments. The casdatifan development strategy is designed to generate evidence needed to establish casdatifan as a backbone therapy so that every ccRCC patient has the opportunity to benefit from casdatifan across each line of therapy. In addition to partner-operationalized studies, Arcus is investigating casdatifan across multiple cohorts in the ARC-20 platform study, alone and in combination with other potential new treatment options, including in the: * First-line setting with cohorts evaluating casdatifan plus zimberelimab, an anti-PD-1 (ongoing); and casdatifan plus zimberelimab and ipilimumab, an anti-CTLA-4 (ongoing) * Second-line setting with a cohort evaluating casdatifan plus cabozantinib in immunotherapy (IO)-experienced patients (ongoing) * Late-line setting with a cohort evaluating casdatifan plus a TKI in both HIF-2a inhibitor-experienced and HIF-2a inhibitor-naive patients (planned) Arcus is also enrolling patients for PEAK-1, the global Phase 3 study evaluating casdatifan plus cabozantinib versus cabozantinib in IO-experienced metastatic ccRCC. Arcus expects to complete enrollment in PEAK-1 and to initiate a Phase 3 study in first-line metastatic ccRCC by year-end 2026. Casdatifan is an investigational molecule. Approval from any regulatory authority for its use has not been received, and its safety and efficacy have not been established. Taiho has development and commercial rights in Japan and other countries in Asia, excluding China. Arcus Biosciences holds full rights to casdatifan everywhere else globally. About Pumitamig (BNT327/BMS986545) Pumitamig is a novel investigational bispecific antibody, jointly developed by BioNTech and BMS, combining two complementary, validated mechanisms in oncology into one single molecule. Pumitamig combines PD-L1 checkpoint inhibition aimed at restoring T cells' ability to recognize and destroy tumor cells with the neutralization of VEGF-A. BioNTech and BMS are currently advancing pumitamig in a broad clinical trial program with more than 20 clinical trials currently ongoing or planned to evaluate pumitamig either as a monotherapy or in combination with other treatment modalities targeting different oncogenic pathways in more than 10 solid tumor indications. About Kidney Cancer According to the American Cancer Society, kidney cancer is among the top 10 most commonly diagnosed forms of cancer among both men and women in the U.S., and an estimated 80,450 Americans will be diagnosed with kidney cancer in 2026. ccRCC is the most common type of kidney cancer in adults. If detected in its early stages, the five-year survival rate for kidney cancer is high; for patients with advanced or late-stage metastatic kidney cancer, however, the five-year survival rate is only 19%. For metastatic kidney cancer, targeted drug therapies are one of the main treatment options. About Arcus Biosciences Arcus Biosciences is a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules for the treatment of cancer and inflammatory and autoimmune diseases. In partnership with industry collaborators, patients and physicians around the world, Arcus is expediting the development of its late-stage portfolio of first- and/or best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has advanced multiple investigational medicines into registrational clinical trials including casdatifan, a HIF-2a inhibitor for clear cell renal cell carcinoma, and quemliclustat, a small-molecule CD73 inhibitor for pancreatic cancer. For more information about Arcus Biosciences' clinical and preclinical programs, please visit www.arcusbio.com. Arcus Forward-Looking Statements This press release contains forward-looking statements. All statements regarding events or results to occur in the future contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, the potential of casdatifan and pumitamig to achieve more sustained tumor control and deliver a TKI-free option in the first-line setting, statements regarding Arcus's development strategies and plans, and the timing and achievement of milestones, including the completion of enrollment in PEAK-1 and the initiation of a Phase 3 study in 1L metastatic ccRCC. All forward-looking statements involve known and unknown risks and uncertainties and other important factors that may cause Arcus's actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, risks associated with: managing Arcus's collaborations; risks associated with manufacturing or supplying casdatifan; the unexpected emergence of adverse events or other undesirable side effects with casdatifan or casdatifan-based combinations; changes in the competitive landscape for Arcus's programs; and the inherent uncertainty associated with pharmaceutical product development and clinical trials. Risks and uncertainties facing Arcus are described more fully in the "Risk Factors" section of Arcus's most recent periodic report filed with the U.S. Securities and Exchange Commission (SEC) and in other filings that Arcus makes with the SEC from time to time, which are available at www.sec.gov. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Arcus disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release, except to the extent required by law. The Arcus name and logo are trademarks of Arcus Biosciences, Inc. All other trademarks belong to their respective owners. Arcus Investor & Media Inquiries: Holli Kolkey VP of Corporate Affairs (650) 922-1269 [email protected] Maryam Bassiri Director of Corporate Affairs (510) 406-8520 [email protected]

Yahoo Finance
May 16th, 2026
Analysts slash Arcus Biosciences revenue forecast by 70% to $72M for 2026

Analysts covering Arcus Biosciences have sharply reduced their revenue forecasts, with consensus estimates for 2026 now at $72 million, down from $91 million previously. This represents a concerning 70% decline from the company's sales over the past 12 months. The 11 analysts maintained their price target of $34.36 despite the downgrade. The revised forecasts suggest an annualised revenue decline of 80% by end-2026, a stark contrast to the company's 3.3% annual growth over the past five years. Arcus Biosciences' outlook appears significantly weaker than the broader industry, where companies are expected to see 22% annual revenue growth. The substantial reduction in estimates may signal concerns for shareholders about the biotechnology company's near-term prospects.

Yahoo Finance
Apr 25th, 2026
Arcus Biosciences up 5.2% despite lung trial halt as Gilead narrows collaboration scope

Arcus Biosciences shares rose 5.2% after discontinuing two lung cancer trials following futility analysis, whilst Gilead Sciences will allow its option rights on several early-stage Arcus programmes to lapse in July 2026. The Phase 3 STAR-121 and Phase 2 EDGE-Lung studies for domvanalimab and zimberelimab in metastatic non-small cell lung cancer were halted after pre-planned analysis, though no new safety issues emerged. Zimberelimab plus chemotherapy showed overall survival comparable to pembrolizumab plus chemotherapy. Gilead's decision narrows the collaboration's scope whilst leaving Arcus with full rights to casdatifan outside territories licensed to Taiho. The company's investment narrative now centres on casdatifan and select oncology assets, with revenue projected to decline 10.3% yearly to $178.6 million by 2029.