Spyre Therapeutics Inc jobs

Senior Payroll and Accounting Specialist US- Remote Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23. Role Summary: Spyre Therapeutics, Inc., is actively recruiting an experienced Senior Payroll and Accounting Specialist to join our accounting team. The Payroll and Accounting Specialist will be a key member of the accounting department, responsible for the integrity of the Company's compensation cycles and equity administration. Responsibilities include full-cycle general ledger accounting, end-to-end payroll administration, equity platform management, and ensuring strict adherence to Sarbanes-Oxley (SOX) requirements. This position will support our increased operational needs as our company grows, playing a vital role in reconciling stock-based compensation, managing payroll tax compliance, and other accounting tasks as needed. Attention to detail and the ability to maintain precise account balances and general ledger accuracy are all essential skills for this position. The ideal candidate should be comfortable working collaboratively with cross-functional teams and independently and excel when faced with the unique challenges of a scaling organization. Key Responsibilities: - Manage the full-cycle payroll process, including data entry, tax withholdings, and benefits deductions, etc. - Ensure all payroll activities align with federal, state, and local tax regulations, including the proper handling of withholdings and filings. - Perform regular audits of payroll data and reconcile payroll bank accounts to ensure accuracy and identify

Clinical Trial Manager, Clinical Operations US- Remote Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23. Role Summary: The Clinical Trial Manager (CTM) is a pivotal role responsible for the management of Clinical Trials from vendor selection through Clinical Study Report (CSR) completion. The CTM will organize and supervise clinical trials, ensuring they meet all company and regulatory requirements. The CTM will collaborate closely with internal R&D team members in addition to external CRO partners to drive successful trial execution to advance the development of our cutting-edge antibody conjugate portfolio ensuring efficacy, safety, and regulatory success. Key Responsibilities: - Responsible for the management of Clinical Trials from vendor selection through Clinical Study Report (CSR) completion. - Ensure clinical trial activities are completed on time, within budget and in a highly dynamic and complex environment in accordance with appropriate quality standards including ICH/GCP requirements. - Create and implement study-specific clinical monitoring tools and documents, including informed consent development and EU CTR. - Lead the identification, evaluation, selection, and oversight of clinical trial sites. - Author and implement operational plans to ensure efficient study enrollment and high-quality monitoring activities at clinical sites. - Review/approve vendor and site invoices and track study budget to forecast, working closely with finance and clinical business operations. - Responsible for implementation

Senior Director, Biostatistics US- Remote Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23. Role Summary: The Sr. Director of Biostatistics will provide leadership and strategic input for clinical development programs assigned. The selected individual will be responsible for statistical activities supporting clinical trials, including contributing to trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data. This is a hands-on role where you will interact with internal and external cross-functional study teams, support interactions with Health Authorities globally, conduct ad-hoc analyses, and manage biometrics vendors in preparing analysis files, performing statistical analyses, and delivering analysis results and data files. Key Responsibilities: - Lead the biometrics team including statistician, data manager, and statistical programmer at a program level. - Provide statistical input to strategic planning, study design, protocol development, sample size calculation, CRF, Results Interpretation, clinical study report, and address questions from regulatory agencies. - Promote research of advanced and innovative statistical methods to increase probability of success of clinical studies. - Author and develop SAPs, and work with extended team or vendor in developing specification for derived variables, templates of statistical tables, figures, and listings. - Provide guidance to study team on all aspects of statistical activities; collaborate closely with data manager

Senior Manager, Regulatory Affairs CMC US- Remote Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23. Role Summary: As the Senior Manager, Regulatory Affairs CMC), you will operate as the Regulatory CMC lead for multiple programs, owning strategy and execution from early development through clinical milestones. This is a high-impact, high-ownership role for someone who thrives in a fast-moving biotech environment. You will be expected to lead from the front-writing, project-managing, problem-solving, and delivering-not just coordinating. This role requires technical CMC expertise, strong communication skills, and the ability to manage multiple priorities. Key Responsibilities: - Act as the Reg CMC lead for assigned programs, driving strategy, execution, and timelines. - Personally author sections of Module 2 and 3 (QOS, drug substance, drug product, comparability, stability, etc.). - Own CMC regulatory deliverables end-to-end with minimal oversight. - Lead and deliver global submissions (INDs, IMPDs, CTAs, amendments, annual reports) with a focus on timeliness, quality, and completeness. - Identify risks early and lead teams to resolution to keep programs on track. - Translate complex technical data into clear and concise narratives. - Lead preparation of CMC-related responses to HA questions. - Act as a connector and leader in discussions, not a passive participant. - Manage multiple programs, while prioritizing effectively. - Other duties as assigned. Ideal

Associate Director, Analytical Sciences and Attribute Characterization US- Remote Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23. Role Summary: The Associate Director, Analytical Sciences and Attribute Characterization, oversees structural and functional characterization and comparability studies across Spyre's clinical and late-stage mAb and mAb-mAb combination programs. This role is a key leader within the Analytical Development and Quality Control (ADQC) organization and reports directly to the Vice President. The position provides both strategic and operational leadership for analytical characterization and comparability, in close collaboration with internal process, analytical, and regulatory teams, as well as global CDMO partners. The Associate Director defines phase-appropriate characterization and comparability strategies that support formulation, process, and analytical development, quality control, and regulatory submissions, aligned with regulatory expectations and industry best practices. This role drives proactive planning to ensure efficient advancement of drug candidates through clinical development stages. Key Responsibilities: - Provide strategic and technical leadership for multidimensional biologics characterization to support product understanding and comparability in a phase-appropriate manner, enabling regulatory submissions for clinical development through BLA & MAA, primarily executed through global CDMO partners. - Serve as subject matter expert (SME) in mAb and mAb-mAb combination product molecular characterization and comparability, applying a fit-for-purpose suite of biochemical, biophysical, physicochemical, and functional assays (e.g., advanced mass spectrometry, capillary and

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Therapeutic Area Head – Respiratory Remote About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, Apogee's antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company's most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today's standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values: C aring, O riginal, R esilient and E goless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! Role Summary We are seeking a Therapeutic Area (TA) Head, Respiratory - Clinical Development. In this

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Information Security Lead New York, NY Who We Are: Click Therapeutics, Inc., develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs. As a leading innovator of Digital Therapeutics™, Click delivers accessible, clinically proven, FDA-regulated prescription treatments to the smartphone in your hand. Click's treatments are defined by a commitment to applying technical and scientific rigor and patient-centric design to the development process. This results in uniquely engaging experiences that achieve compelling clinical outcomes for patients seeking new treatment options. Click Therapeutics continuously expands and refines its platform with novel cognitive, behavioral and neuromodulatory mechanisms of action and advanced data-driven tools such as artificial intelligence and machine learning. The digital therapeutics under development on Click's platform address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, immunology, and cardiometabolic diseases. Consistently named a best place to work, Click fosters an inclusive, diverse workforce of innovators, clinicians, scientists, researchers, designers, technologists, engineers and more, united in a common mission to provide patients everywhere access to safe and effective prescription digital therapeutics. For more information, visit www.clicktherapeutics.com and connect with us on LinkedIn. About the Role: As Information Security Lead, you'll be at the forefront of safeguarding our groundbreaking digital therapeutics. We're seeking an individual with deep technical expertise in information security in the healthcare sector, ready to tackle complex challenges and pioneer innovative solutions. This isn't just a role; it's an opportunity to build, mentor, and inspire a high-performing team, while strategically collaborating across

Therapeutic Area Manager (TAM), Breast - Pennsylvania Ecosystem Wilmington, Delaware, United States of America Embrace the opportunity to become a Therapeutic Area Manager, Breast, and drive impactful patient outcomes in the Pennsylvania ecosystem. Leverage your expertise in healthcare sales, account management, and cross-functional collaboration to optimize product access and support innovative treatments. Make a difference in the rare disease community with Genentech.

Principal Product Leader, Therapeutics Discovery South San Francisco, California, United States of America Exciting opportunity for a Principal Product Leader in Therapeutics Discovery, driving strategy and innovation for cutting-edge products in drug discovery. Collaborate with top scientists, shape product vision, and accelerate impactful solutions in a dynamic, data-driven environment. Make a difference in advancing life-changing therapies and scientific discovery at the forefront of biotechnology.

Executive Director, Therapeutic Area Lead, CVRM South San Francisco, California, United States of America Exciting opportunity for an Executive Director, Therapeutic Area Lead and drive medical strategy, innovation, and leadership in a dynamic healthcare environment. Lead high-impact teams, shape clinical trials, and collaborate across functions to advance patient outcomes. If you have deep medical expertise and proven people management skills, this is your next career-defining opportunity.

Associate Director, Device Development Remote About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, Apogee's antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company's most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today's standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values: C aring, O riginal, R esilient and E goless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! Role Summary Apogee Therapeutics is seeking an Associate Director, Device Development to join the Technical Operations team

Vice President, Commercial Manufacturing Operations Remote Vera Therapeutics is a biotechnology company focused on developing treatments for serious immunological diseases. Vera Therapeutics' mission is to advance treatments that target the source of disease in order to change the standard of care for patients. Vera Therapeutics' lead product candidate is atacicept, a fusion protein self-administered at home as a subcutaneous once weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN) and lupus nephritis. Beyond IgAN, Vera Therapeutics is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove clinically meaningful. In addition, Vera Therapeutics holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B-cell-mediated diseases. Vera Therapeutics is also evaluating the development of MAU868, a monoclonal antibody designed to neutralize infection with BK virus, which can have devastating consequences in kidney transplant recipients. Vera Therapeutics retains all global developmental and commercial rights to atacicept, VT-109, and MAU868. For more information, please visit www.veratx.com . Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do-from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases. Position Summary: The Vice President, Manufacturing Operations will report

Therapeutic Area Policy Director South San Francisco, California, United States of America Exciting opportunity for a strategic policy director to shape healthcare policy and optimize patient access across diverse therapeutic areas. Lead cross-functional teams, influence policy at the highest levels, and drive strategic readiness for innovative therapies. Join us to make a significant impact on patient outcomes and healthcare innovation.

Executive Director, Therapeutic Strategy Leader, APAC Shanghai, China This role is for upcoming future opportunities that may arise at Fortrea. Fortrea is excited to connect with talented individuals for future opportunities. If you meet the job requirements, we'll i...