Generate Biomedicines

• Independently manages the operational aspects of Generate Biomedicines’ clinical trials, including vendors such as CROs, central labs, biomarker and specialty laboratories, and clinical trial sites, specifically late stage needs in Asthma/COPD. • Leads cross-functional internal study team meetings and meeting deliverables. • Identification, qualification, and selection of clinical trial sites and investigators alongside CRO including management of key relationships. • Leads day-to-day supervision of clinical trial execution, with a focus on site start up, patient enrollment, monitoring, compliance, and data flow metrics from the clinical sites, CROs and central labs. • Facilitates investigator meetings, kick-off meetings, monitoring training, and various CRO (or other vendor) meetings. • Development and review of specific study documents e.g. informed consent forms, study guidelines, operations manuals, training materials. • Participation in the development of clinical trial protocols, amendments, CRFs, IRB/Ethics applications, and recruitment materials. • Management of clinical study budgets and execution timelines. • Ensures adherence to study timelines and project and program goals. • Attends and leads monitoring oversight visits and effective collaboration with CRO, Investigators, and site staff on any outcomes/findings. • Reviews study reports and metrics to ensure timely collection of clinical data, samples, and lab results. • Collaboration on SOP development and promotion of standardized clinical business tools. • Development of action plans to address protocol compliance, safety, data and administrative issues with investigational sites and CROs. • Maintenance and oversight of Trial Master File for assigned studies. • Collaborate with QA and cross functional teams to ensure inspection readiness activities for assigned clinical trials, ensuring TMF completeness, audit preparedness, and compliance with GCP, SOPs, and applicable regulatory requirements. • Participation in the preparation of presentations of trial data for internal and external parties (management review, scientific meetings, and advisory boards). • Trains and mentors junior staff.

• Serve as clinical science lead and core member of clinical development team for one or more respiratory studies (asthma and/or COPD) • Support day-to-day study execution, ensuring alignment with protocol, timelines, and regulatory requirements • Act as a key scientific contributor to late-stage protocols and regulatory submissions; design and develop clinical trial protocols and associated documents (e.g. clinical study plans, data review plans, case report forms (CRFs), database design, statistical analysis plans) in collaboration with the clinical development leader • Participate in medical monitoring activities: review and interpret clinical data on an ongoing basis in collaboration with cross-functional colleagues and external partners to ensure data quality, participant safety, and protocol compliance • Participate in site selection, initiation, and ongoing engagement; provide scientific support to investigators and address protocol-related inquiries • Serve as a core member of the clinical operations study delivery team, contributing to trial execution and oversight: track study progress against milestones and identify risks to timelines or data integrity, propose and help implement mitigation strategies, and serve as key scientific contact for CROs and vendors. • Collaborate with Clinical Operations, Regulatory, Biostatistics, Data Management, and Safety teams to ensure alignment and trial execution • Contribute to internal governance meetings (presenting or preparing study updates, data summaries, and key risks/issues) • Ensure inspection readiness (maintain high-quality documentation and support audit/inspection activities) • Support development and execution of publication plans, abstracts, and manuscripts • Contribute to TPPs, clinical development plans, and risk-benefit assessments • Support medical monitor with management of oversight committees for late-stage asthma studies (e.g., DSMB, Endpoint Adjudication Committee)

Support drug substance process development, execute scale-up studies, and oversee tech transfer while ensuring GMP compliance and documentation integrity. Collaborate cross-functionally to drive continuous improvement and robust program execution.

• Serve as clinical science lead for respiratory studies (asthma and/or COPD) • Support day-to-day study execution • Act as a key scientific contributor to late-stage protocols and regulatory submissions • Participate in medical monitoring activities • Engage in site selection and provide scientific support • Collaborate with multiple teams for trial execution • Maintain high-quality documentation for audit readiness • Support development and execution of publication plans

• Leads a high performing Respiratory Product Strategy Team (RPST) comprised of cross-functional leaders accountable for setting the strategy for the late stage respiratory programs • Develops high quality, ambitious development plans for asthma and COPD programs, aligned with late-stage and corporate objectives and compliant with all relevant regulations • Recruits, mentors and develops a team of late-stage clinicians and scientists • Collaborates with Head of Safety and PV to define risk-benefit profiles • Collaborates with Clinical operations and CRO to deliver study to timelines and budget • Oversees protocol development and clinical/scientific content for regulatory submissions and interactions • Provides medical leadership and awareness of evolving external landscape for late-stage clinical trials in respiratory diseases (asthma, COPD) • Drives development and refinement of Target Product Profiles (TPPs), Target Product Claims, and clinical development strategies • Oversee protocol development, study design, medical review of data, and safety monitoring • Serve as the primary medical contact for clinical sites, investigators, and regulatory bodies • Guide interactions with external stakeholders including KOLs, advisory boards, and CROs • Represent Generate externally at scientific, medical, and regulatory meetings

Title: Scientist I - Scientist II, Computational Protein Generation Location: Somerville, MA Job Description: The Role: We are seeking a creative, motivated Computational Scientist to join our Model-Driven Design team at Generate:Biomedicines. You will join a talented and collaborative group of ML scientists, engineers, and wet-lab scientists dedicated to redefining how medicines are made. This role sits at the intersection of machine learning, structural biology, and therapeutic development, where you will stay at the leading edge of internal and external models for de novo protein design and systematically benchmark, integrate, and apply them within tightly integrated design–build–test–learn cycles to advance our therapeutic pipeline and impact patients' lives. The ideal candidate combines deep structural intuition with a demonstrated ability to rapidly assess and apply protein design methods and metrics across diverse design problems, thinks in terms of reusable capabilities, benchmarks, and feedback loops across applications, and uses modern generative models and experimental readouts to guide iterative design cycles across modalities. You don't just run existing tools; you understand what's missing from current approaches and are driven to fill those gaps. This role is based in our Somerville, MA office with flexibility for hybrid work. Here's how you will contribute: - Model application and optimization: develop, validate, and productionize de novo protein generation protocols and optimization techniques on our experimental platform, using measured data in-the-loop to iteratively refine models across modalities and therapeutic applications. - Define and implement in silico metrics: design, interpret, and implement biophysical and functional metrics for evaluating generated designs, leveraging existing literature, adapting known metrics to new contexts, and performing original research to benchmark and deploy new scoring approaches. - Benchmark foundation models and guide their application: rigorously evaluate new models and tools and provide quantitative conclusions on where they are best applied to generate new therapeutics, including designing systematic internal benchmarks and discovering how to expand model capabilities to prosecute new therapeutic targets in novel ways and to maximize reuse across targets and programs. - Propose new therapeutic strategies: identify and implement solutions to create new therapeutics through mechanisms of action unlocked by de novo tools and modalities. - Partner cross-functionally to drive therapeutic development: work closely with experimental colleagues, biologists, and clinical scientists to define design objectives, interpret experimental readouts, and guide iterative design-build-test-learn cycles that advance programs. - Advance the state of the art: push forward sequence–structure–function understanding with a focus on reusable platform capabilities and model-informed feedback loops. - Integrate agentic tools into workflows: leverage agentic AI tools to rapidly iterate on models, benchmarks, scores, critics, and other analysis tools, accelerating the pace of discovery. - Build production-quality tools: develop robust, production-ready code in a collaborative team setting and present scientific progress in regular research meetings. What Success Looks Like - First 3 months: You have familiarized yourself with the proprietary Generate platform and either completed a first-pass design for a therapeutic program or built and applied your first internal tool or benchmark. - By 6 months: You are fully fluent in the Generate stack. You have taken ownership of building or extending a segment of the platform applied to protein design, including designing or maintaining key benchmarks or metrics, or you are contributing materially to an active therapeutic program, driving design decisions with increasing independence. - By 12 months: Given strategic direction, you operate with full autonomy scoping, building, and deploying new tools and methods that advance our protein design capabilities and therapeutic pipeline and strengthen our continuously learning, model-informed design platform. The Ideal Candidate will have: - PhD in Computational Biology, Biophysics, Computer Science, or a related field, with demonstrated experience in protein design applications. - 0–2 years of experience applying computational and/or ML methods to protein design, modeling, or prediction. - Hands-on experience with machine learning and generative modeling for protein design, including familiarity with modern methods such as RFDiffusion, ProteinMPNN, BindCraft, BoltzDesign, or equivalent approaches and how to deploy or evaluate them in practice. - Strong structural intuition and understanding of protein biophysics with the ability to quickly assess and adapt design methods and metrics to new problems. - Familiarity with protein therapeutic modalities such as antibodies, mini-proteins, VHHs, peptides, or enzymes, and an eagerness to deepen expertise across these within de novo design workflows. - Proficiency in Python and scientific computing; comfort working in a production codebase. - Experience designing, running, or interpreting benchmarks for computational or generative methods and drawing quantitative conclusions about model applicability and limitations. Strongly Preferred - Experience designing, executing, and interpreting experiments and experimental data (e.g., binding assays, stability measurements, structural characterization) and using those readouts to inform computational design iterations. - Familiarity with agentic AI tools and their integration into scientific workflows. - Exposure to structure-based design techniques and computational tools for modeling protein-protein interactions. - Track record of translating research ideas into working software or reusable platform components used across multiple projects or applications. About Generate Biomedicines We are a clinical-stage generative biology company pioneering the AI revolution in drug design and development. We are advancing a new approach to drug creation—one grounded in the ability to design proteins with defined biological intent. By integrating machine learning with large-scale experimentation, this approach aims to reduce the uncertainty, time, and cost associated with developing protein-based medicines. Founded in 2018, we are advancing a growing pipeline of clinical and preclinical programs across multiple disease areas and protein modalities. By unifying computational design and clinical development within a single operating model, we translate this approach into clinical-stage programs and are leading a shift from traditional drug discovery toward systematic drug generation. At Generate:Biomedicines, we collaborate across disciplines in new ways to invent and innovate. We bring diverse perspectives to a shared goal of delivering better medicines to patients in need, faster, guided by our values and leadership behaviors. Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto. Compensation: The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package. Per Year Salary Range $140,000 - $200,000 USD

The Role: Generate:Biomedicines is seeking a highly motivated and experienced Director, Clinical Scientist to support the development of our respiratory programs, with a focus on asthma and COPD. This individual will serve as the clinical science lead on cross-functional study teams for Phase 2 and 3 trials, driving protocol development, data analysis, and regulatory documentation. The ideal candidate will bring deep expertise in late-stage clinical trial design and execution in respiratory indications, along with a proactive, solution-oriented mindset. Here's how you will contribute: - Serve as clinical science lead and core member of clinical development team for one or more respiratory studies (asthma and/or COPD) - Act as a key scientific contributor to late-stage protocols and regulatory submissions - Design and develop clinical trial protocols and associated documents in collaboration with the clinical development leader - Drive development of clinical study plans, data review plans, and clinical components of regulatory documents (e.g., IBs, CSRs, briefing books) - Interpret clinical data in collaboration with cross-functional colleagues and external partners - Provide scientific input into case report forms (CRFs), database design, and statistical analysis plans - Participate in data review and medical monitoring activities - Serve as a core member of the clinical operations study delivery team, contributing to trial execution and oversight - Collaborate with Clinical Operations, Regulatory, Biostatistics, Data Management, and Safety teams to ensure alignment and trial execution - Support development and execution of publication plans, abstracts, and manuscripts - Contribute to TPPs, clinical development plans, and risk-benefit assessments - Support medical monitor with management of oversight committees for late-stage asthma studies (e.g., DSMB, Endpoint Adjudication Committee) Leadership Responsibilities - Take ownership of clinical execution and ensure accountability to high standards of quality and rigor - Collaborate across functions with transparency and technical precision - Foster an inclusive and high-performing team culture, offering mentorship and coaching where appropriate - Communicate clearly and consistently, using data to inform decisions and recommendations - Adapt readily to change and demonstrate resilience and curiosity in the face of ambiguity The Ideal Candidate will have: - Advanced degree (PhD, PharmD, MD, MS, PMP ) and 9+ years of industry experience in clinical development, including direct experience in late stage respiratory (asthma and/or COPD) studies - Strong knowledge of clinical research methodologies, regulatory guidelines, and GCP - Demonstrated ability to lead clinical science strategy and execution in late-stage trials - Excellent analytical, communication, and cross-functional collaboration skills - Prior experience authoring clinical protocols, CSRs, and regulatory documents Education PhD, PharmD, MD or equivalent required; respiratory scientific background preferred Nice to Have (Optional) - Experience with both small molecule and biologic modalities - Familiarity with AI/ML-driven drug discovery platforms - Previous involvement in BLA or MAA submissions Who Will Love This Job: This is a unique opportunity to shape the future of respiratory medicine within a company pioneering Generative Biology™. At Generate:Biomedicines, you’ll be part of a fast-moving, purpose-driven team translating cutting-edge science into meaningful therapies for patients. . About Generate:Biomedicines We are a clinical-stage generative biology company pioneering the AI revolution in drug design and development. We are advancing a new approach to drug creation—one grounded in the ability to design proteins with defined biological intent. By integrating machine learning with large-scale experimentation, this approach aims to reduce the uncertainty, time, and cost associated with developing protein-based medicines. Founded in 2018, we are advancing a growing pipeline of clinical and preclinical programs across multiple disease areas and protein modalities. By unifying computational design and clinical development within a single operating model, we translate this approach into clinical-stage programs and are leading a shift from traditional drug discovery toward systematic drug generation. At Generate:Biomedicines, we collaborate across disciplines in new ways to invent and innovate. We bring diverse perspectives to a shared goal of delivering better medicines to patients in need, faster, guided by our values and leadership behaviors. Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto. #LI-RT1 Compensation: The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package. Per Year Salary Range $186,000—$279,000 USD

The Role: We are seeking an experienced hands on statistical programming expert to join our team. In this role you will be partnering with head of clinical and statistical programming to set standards, ensuring compliance based on CDISC standards, overseeing the work provided by external CRO partners and internal contractors, taking ownership of programming deliverables, supervising and mentoring programming staff, allocating resources effectively, identifying gaps and implementing improvements in programming and infrastructure, resolving issues related to clinical and translational data, and upholding company values through excellence, teamwork, innovation, respect, and accountability. You will collaborate closely with clinical study team including biostatisticians, data managers, CROs, Clinical scientists, translational scientists, SMEs from Clinical operations, Pharmacovigilance, Quality, and IT on various tasks. This is an exciting opportunity for a visionary individual who is ambitious, detail-oriented, and passionate about advancing statistical programming to drive innovation in clinical research. If you are eager to develop cutting-edge programming solutions, optimize data analysis, and contribute to impactful advancements in human health, this role is for you. This position can be remote or onsite at our Somerville, MA location. Here's how you will contribute: - Lead statistical programming activities for multiple clinical trials within a program or an indication /disease area, or development program. • Accountable for timely and quality development and validation of all statistical programming components on assigned program(s). Responsible for audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results. • Serve as the lead programmer to produce and/or validate tables, listings, figures, and analysis datasets for regulatory requests, publication needs, and ad-hoc analyses; write specifications for programming requirements. • Coordinate activities of internal / external programmers. Make statistical programming decisions and propose strategies at program or indication/disease level. Develop scientific documentation for the program(s) or indication/disease area together with the Biostatistician(s). • Independently develop SAS or other programs, and specifications, for use in study or other analyses, such as Integrated Safety Summaries. • Manage the statistical computing environment, including folder structure and access control. • Work closely with Data Management and Biostatistics teams to ensure the accuracy of final databases, analyses, and reports. Oversee study-level programming deliverable timelines in collaboration with the study lead biostatistician and cross-functional teams. • Manage CROs and contractors, ensuring compliance, quality of deliverables, timelines, and budget adherence. • Collaborate with biostatisticians and clinical development colleagues to develop/review TFL shells, SDTM, and ADaM specifications. • Collaborate with cross functional departments - Clinical operations, Translational science, Clinical science, Pharmacovigilance to gather the requirements and provide necessary outputs and analyses in SAS and Spotfire dashboards as per the requirement. • Identify issues and develop global tools, such as macros or graphical user interfaapplications, to enhance the efficiency and capacity of the Statistical Programming group. • Must be able to program defensively, check results, and consistently produce accurate output. • Responsible for allocating resources within a program and ensuring resource sharing between programs. • Recruit, mentor, and develop statistical programmers and interns. • Build and maintain effective working relationships with cross-functional team members within the clinical trial/program, and able to summarize and discuss status of deliverables and critical programming aspects with them (timelines, scope, resource plan). • Maintain up-to-date advanced knowledge of programming software (e.g. SAS/R) as well as industry requirements (e.g. CDISC, eCTD, Define.xml), attend functional meetings and training. • Represent statistical programming at indication or program-level, in audits/inspections and Health Authority (HA) meetings, and on technical programming aspects in external conferences or consortiums (e.g. CDISC). • Offer expert technical and professional recommendations, thought leadership for the SP function at the indication/ program level or for non-clinical initiatives. • Adhere to FDA regulations regarding training records, guidelines, and SOPs. • Adhere to company SOPs/WIs and department guidelines. The Ideal Candidate will have: • BS/MS degree in life science, computer science, statistics, mathematics, or equivalent relevant degree and 10+ years of experience in Statistical programming, and Clinical programming. • 3+ years of line management or equivalent leadership experience, with demonstrated ability to lead, mentor, and oversee multiple trials or programs simultaneously while meeting timelines and quality expectations. • In-depth understanding of clinical trials methodology, regulatory requirements, and Good Clinical Practice (GCP). • Advanced SAS programming expertise in a clinical trial environment, including Base SAS, SAS/STAT, SAS Macro language, and generation/validation of tables, listings, and figures (TLFs). • Strong experience in development, validation, and review of SDTM and ADaM datasets, including specifications and submission-ready deliverables within a Statistical Programming environment. • Advanced knowledge of regulatory requirements and industry standards, including FDA, EMA, ICH, and CDISC, with strong understanding of clinical trial data handling and submission expectations. • Expert in SAS and/or R programming, including creation of SDTM/ADaM specifications, development and validation of deliverables within a Statistical Programming environment, and the creation of advanced SAS macros and/or functions. • Significant experience contributing to or reviewing Statistical Analysis Plans, Data Management plans, Programming SOPs, work instructions and programming specifications. • Strong experience developing and maintaining standard programs, reusable macros, and programming utilities to improve quality, consistency, and efficiency. • At least 3+ years of experience as a Lead/Program/Project Programmer for one or more programs/indications, including coordination of internal and/or external programming teams. • Experience outsourcing programming activities and providing oversight of CROs, vendors, and contractors, including deliverable review, timeline management, and quality oversight. • NDA submission experience is required. • Experience with R programming, Spotfire visualization, and/or Generative AI tools for analytics, visualization, automation, or process improvement is a plus. • Excellent interpersonal skills with a proven ability to operate effectively in a global environment, influencing and communicating across functions and with external stakeholders. • The ability to thrive in various situations, enthusiastically embracing organizational changes and evolving job demands. • Skilled at planning and managing multiple responsibilities concurrently, while maintaining high standards of quality and meeting deadlines under pressure. About Generate:Biomedicines We are a clinical-stage generative biology company pioneering the AI revolution in drug design and development. We are advancing a new approach to drug creation—one grounded in the ability to design proteins with defined biological intent. By integrating machine learning with large-scale experimentation, this approach aims to reduce the uncertainty, time, and cost associated with developing protein-based medicines. Founded in 2018, we are advancing a growing pipeline of clinical and preclinical programs across multiple disease areas and protein modalities. By unifying computational design and clinical development within a single operating model, we translate this approach into clinical-stage programs and are leading a shift from traditional drug discovery toward systematic drug generation. At Generate:Biomedicines, we collaborate across disciplines in new ways to invent and innovate. We bring diverse perspectives to a shared goal of delivering better medicines to patients in need, faster, guided by our values and leadership behaviors. Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto. #LI-RT1 Compensation: The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package. Per Year Salary Range $162,000—$227,000 USD

The Role: We are seeking a dedicated Senior eTMF Specialist who supports sponsor-side eTMF operations and CRO oversight activities for assigned clinical studies. This role is responsible for execution of TMF management activities, ensuring TMFs are inspection-ready, complete, and compliant. The position works under the guidance of the Associate Director and focuses on operational delivery. Here's how you will contribute: - Serve as primary eTMF contact for studies, ensuring questions related to eTMF items are addressed in a timely manner. - Manage the quality control/completeness of TMF documents according to GCP and regulatory requirements from study start-up to study closeout/archival and preparation for inspections. - Collaborate with internal and external stakeholders (e.g. CRO, Partners) in the management of eTMF related activities, including but not limited to monitor TMF inventory lists, EDLs, metrics, periodic TMF reviews according to study-specific TMF plans, oversee KPIs, and identify areas for improvement. - Provide TMF guidance to study teams based on established processes - Support training on TMF expectations as needed - Provide input on TMF related Work Instructions, SOPs, and tools. - Support TMF elements of regulatory inspections by providing relevant documents and responses as needed. - May support inspection preparation activities as needed CRO/Vendor Oversight - Support oversight of CRO/vendor-managed TMFs through regular reviews and follow-ups - Track TMF-related issues, action items, and ensure timely resolution with CROs - Participate in TMF review meetings and provide updates on status and risks - Escalate risks, delays, or quality concerns to the Associate Director as appropriate - Assist in reconciliation activities between sponsor and CRO TMFs The Ideal Candidate will have: - BSc required in a biomedical, life science, or related field of study - Minimum of 4 years’ industry experience in supporting the operations of clinical studies, including duties related to TMF Operations oversight. - Proficiency with TMF, GCP and eTMF systems. - Expertise in Veeva Vault system (e.g., eTMF). - Must have TMF experience working at a sponsor company and not only CRO environment. - Understanding of DIA TMF reference model and cross-functional clinical processes. - Demonstrated experience or knowledge with the clinical research process, including the collection of documents at study start-up, during study conduct and close-out. - Demonstrated understanding of TMF related ICH/GCP guidelines. - Familiarity with the management of global clinical trials, clinical trial documents and the TMF document management process. - Experience with the Veeva electronic trial master file system(s) including uploading, reviewing, quality checks (QC), and approval of study required documents. About Generate Biomedicines We are a clinical-stage generative biology company pioneering the AI revolution in drug design and development. We are advancing a new approach to drug creation—one grounded in the ability to design proteins with defined biological intent. By integrating machine learning with large-scale experimentation, this approach aims to reduce the uncertainty, time, and cost associated with developing protein-based medicines. Founded in 2018, we are advancing a growing pipeline of clinical and preclinical programs across multiple disease areas and protein modalities. By unifying computational design and clinical development within a single operating model, we translate this approach into clinical-stage programs and are leading a shift from traditional drug discovery toward systematic drug generation. At Generate:Biomedicines, we collaborate across disciplines in new ways to invent and innovate. We bring diverse perspectives to a shared goal of delivering better medicines to patients in need, faster, guided by our values and leadership behaviors. Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto. #LI-RT1 Compensation: The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package. Per Year Salary Range $94,000—$132,000 USD

• Provide strategic oversight and end-to-end operational leadership for global Phase 3 COPD studies and related development activities. • Translate program strategy into comprehensive, executable operational plans aligned with regulatory, scientific, and corporate objectives. • Accountable for study timelines, budgets, resource allocation, quality metrics, and overall delivery. • Lead scenario planning, risk forecasting, and mitigation strategies at the program level. • Partner with Clinical Development leadership to inform portfolio-level planning and decision-making. • Directly manage and develop Clinical Operations staff (e.g., Clinical Trial Leads and/or Clinical Trial Managers). • Recruit, hire, onboard, and retain top talent to support late-stage clinical development. • Set performance expectations, conduct evaluations, provide coaching, and support career development. • Build a culture of accountability, collaboration, and operational excellence.