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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Manager, Market Intelligence and Strategy Boston, MA The Organization What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. Through proprietary and versatile approaches, Entrada is advancing a robust development portfolio of genetic medicines for the potential treatment of neuromuscular and inherited retinal diseases, among others. Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne muscular dystrophy (DMD) who are exon 44, 45, 50 and 51 skipping amenable. Entrada has partnered with Vertex Pharmaceuticals to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1 (DM1). 2026 represents a catalyst-rich period for Entrada. We expect multiple clinical data readouts as we advance several DMD programs across the U.K., EU, and U.S. By year-end 2026, we anticipate four clinical-stage programs in our DMD franchise (ENTR-601-44, ENTR-601-45, ENTR-601-50, and ENTR-601-51). These programs are complemented by the ongoing clinical progress of our DM1 collaboration with Vertex (VX-670). We are a tight-knit team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are ready to join a high-energy, dedicated team that likes to get things done and dramatically improve the lives of patients and their families. The Perfect Addition to Our Team You are interested in working at the intersection of life sciences and business. You want to join a high

Principal Scientist, Peptide Therapeutics South San Francisco, California, United States of America This is a primarily lab-based, technical leadership position within the Peptide Therapeutics department. In this lab-based leadership role, you will combine hands-on synthetic expertise with strategic...

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

Therapeutic Area Lead Vaccines & Infectious Diseases POL - Mazowieckie Wojewodztwo - Warsaw (Trade Center) posted: Posted 2 Days Ago

Therapeutic Area Manager (TAM), Hematology - Pennsylvania Ecosystem Philadelphia, Pennsylvania, United States of America Embrace the opportunity to become a Therapeutic Area Manager, Hematology, and drive impactful patient outcomes in the Philadelphia ecosystem. Leverage your expertise in oncology and healthcare systems to lead cross-functional teams, optimize product access, and shape clinical strategies. Make a difference in rare disease care with Genentech.

Director, Patient Marketing US Remote “Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit https://mineralystx.com . Follow Mineralys on LinkedIn , Twitter and Bluesky ” Mineralys is a fully remote company. As we prepare for our first commercial launch, we are seeking an experienced patient marketer who is energized by the opportunity to build from the ground up, establish foundational capabilities and shape the promotional strategy for our first commercial launch. Reporting to the Head of Consumer and Omnichannel Marketing, the Director, Patient Marketing will develop and execute the patient marketing strategy for Mineralys, supporting disease education, brand awareness, patient identification, activation, and a differentiated patient and caregiver experience. This role leads patient strategy and content priorities across journey development, campaigns, market research, advocacy, ambassador and influencer programs, and patient support initiatives. The role partners closely with Omnichannel & Digital Marketing to translate strategy into cohesive execution across digital, media, CRM, and social, while remaining accountable for strategic direction, campaign objectives, agency leadership, and budget pull-through. The ideal candidate is a hands on patient marketer who translates insight into compelling work, leads agency partners with clarity and accountability, and executes with speed and compliance in a launch environment. Key

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.

Vice President, Senior Counsel – Commercial and Compliance US Remote “Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit https://mineralystx.com . Follow Mineralys on LinkedIn, Twitter and Bluesky” Mineralys is a fully remote company. Vice President, Senior Counsel - Commercial & Compliance Mineralys is seeking an energetic, versatile, and highly driven attorney to serve as Senior Counsel, Commercial and Compliance. This individual will serve as a strategic legal partner to the Commercial and Medical Affairs teams and will report directly to the Chief Legal Officer. Prior experience assisting with commercial launch is essential. Key Responsibilities Commercial Legal Leadership - Serve as the primary legal advisor to the Commercial and Medical Affairs teams - Provide strategic counsel across pre-launch and launch activities, balancing legal risk with business objectives - Support commercialization readiness, including promotional strategy, market access, patient services, and distribution models - Draft, review, and negotiate a wide range of commercial agreements (e.g., vendors, patient support programs, speaker programs, distribution, market access) - Lead legal review of promotional and medical materials through MLR/PRC processes - Advise on interactions with HCPs, patients, payors, specialty pharmacies, and government entities - Support commercial and medical affairs activities, including speaker programs, advisory boards,

Associate Director, Health Economics & Outcomes Research/Real-World Evidence (HEOR/RWE) US Remote “Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit https://mineralystx.com . Follow Mineralys on LinkedIn, Twitter and Bluesky” Mineralys is a fully remote company. Position Summary: The Associate Director, HEOR / Real-World Evidence (RWE) plays a strategic and scientific leadership role in developing and executing evidence strategies that support the clinical and economic value of our innovative therapy. This position is responsible for designing and delivering real-world and outcomes research evidence to support medical affairs, market access, and regulatory objectives. The role focuses on generating high-quality, decision-relevant evidence, including observational studies, external control arms, and economic models, and indirect treatment comparisons, to contextualize clinical outcomes, demonstrate value, and support stakeholder decision- making. The Associate Director collaborates cross-functionally with Medical Affairs, biostatistics, and commercial teams, while also engaging external partners such as academic researchers, key opinion leaders, and data vendors. This role contributes to strategic evidence planning, scientific communication, and advancing real-world data capabilities within a matrixed organization. Key Responsibilities: - Lead the design, execution, and oversight of HEOR and RWE studies, including observational studies (retrospective/prospective cohorts), economic models, external control arms and indirect treatment comparisons. - Oversee data

Regional Sales Director - Houston US Remote “Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit https://mineralystx.com . Follow Mineralys on LinkedIn , Twitter and Bluesky ” Mineralys is a fully remote company. Regional Sales Director The Regional Sales Director (RSD) will play a critical role in the successful launch and growth of Mineralys' first commercial product within an assigned region. This leader will be accountable for translating national strategy into regional execution, driving business performance through strong field leadership, cross-functional partnership, and disciplined execution against launch objectives. The RSD will build and lead a high-performing team of territory managers, foster deep customer relationships, and ensure alignment with corporate priorities, compliance standards, and Mineralys' values. This is a highly visible field leadership role requiring strong business acumen, launch experience, and the ability to lead with urgency in a fast-paced, entrepreneurial environment. The RSD will cover a Territory including: - Houston, TX - Shreveport, LA - Jackson, MS Key Responsibilities Commercial Leadership / Launch Execution - Lead all regional launch planning and execution activities to ensure successful market entry and sustained product uptake - Translate national brand strategy into actionable regional business plans and field execution priorities - Lead team

Regional Sales Director - Indiana US Remote “Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit https://mineralystx.com . Follow Mineralys on LinkedIn , Twitter and Bluesky ” Mineralys is a fully remote company. Regional Sales Director The Regional Sales Director (RSD) will play a critical role in the successful launch and growth of Mineralys' first commercial product within an assigned region. This leader will be accountable for translating national strategy into regional execution, driving business performance through strong field leadership, cross-functional partnership, and disciplined execution against launch objectives. The RSD will build and lead a high-performing team of territory managers, foster deep customer relationships, and ensure alignment with corporate priorities, compliance standards, and Mineralys' values. This is a highly visible field leadership role requiring strong business acumen, launch experience, and the ability to lead with urgency in a fast-paced, entrepreneurial environment. The RSD will cover an Indiana Territory including: - Indianapolis, IN - Valparaiso, IN - Evansville, IN - Louisville, KY - Bowling Green, KY Key Responsibilities Commercial Leadership / Launch Execution - Lead all regional launch planning and execution activities to ensure successful market entry and sustained product uptake - Translate national brand strategy into actionable regional business

Associate Therapeutic Development Manager HKG - Hong Kong Island - Hong Kong (Lee Garden Two) posted: Posted 16 Days Ago

Pharmacovigilance Scientist Bedford, Massachusetts, United States About Stoke: Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine. Using Stoke's proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels. Stoke's first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study. Stoke's initial focus are diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for Stoke's proprietary approach. Stoke is headquartered in Bedford, Massachusetts. For more information, visit https://www.stoketherapeutics.com/ Position Purpose: We are building our Pharmacovigilance department in support of ongoing clinical development activities and NDA submission for a first-in-class antisense oligonucleotide (ASO) therapy in a rare pediatric neurological disease. The PV Scientist is a newly created role and a genuine opportunity to shape the scientific infrastructure of PV department at a critical inflection point. The PV Scientist is accountable for overall PV science support for pharmacovigilance department at Stoke, which includes working in collaboration with the Safety Physician(s) and cross-functional teams to lead signal detection activities conducted in the safety governance model within the company. The ideal candidate will have deep PV science experience and will contribute across clinical and regulatory workstreams