Generate Biomedicines

Clinical Operations

• Serve as the operational lead for global Phase 3 asthma studies
• Develop overall study strategy, timelines, and operational plans
• Lead scenario planning, risk assessment, and proactive mitigation efforts
• Review and approve key trial documents
• Lead and coordinate multidisciplinary study teams
• Act as the central point of accountability across stakeholders
• Enable effective communication, decision-making, and timely issue escalation
• Oversee study start-up, site identification, enrollment strategy, monitoring plans
• Ensure study conduct follows ICH-GCP, SOPs, and global regulatory requirements
• Manage study budget, vendor performance, timelines, and quality metrics
• Assist in audit preparation and ensure corrective and preventive actions
• Partner closely with data management and biostatistics for data quality
• Drive inspection readiness and continuous study health assessments
• Provide operational oversight of CROs and ensure deliverables meet expectations

Associate Director, Clinical Operations Lead – Asthma

Vice President

• 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
• Direct management and development of medical monitors and clinical scientists
• 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 manages late-state 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

Vice President, Global Respiratory Products Leader

Director

• Serve as the primary sponsor contact for U.S. clinical trial sites, ensuring consistent communication and support throughout study execution.
• Train site personnel on protocols, study objectives, and the scientific rationale for investigational products.
• Collaborate with sites to develop and refine patient recruitment strategies to meet enrollment targets.
• Identify and resolve operational and compliance challenges in partnership with Clinical Operations and CROs.
• Conduct regular monitoring visits (remote and in-person) to build and sustain productive site relationships.
• Capture and relay insights from sites to inform operational decisions and protocol optimization.
• Contribute to feasibility assessments and site selection activities based on local treatment practices.
• Mentor junior CTLs on core responsibilities, compliance expectations, and communication best practices.
• Support the implementation of consistent standards across U.S. trial sites

Associate Director, US Clinical Trial Liaison

Manager

• Lead statistical programming activities for multiple clinical trials.
• Accountable for timely and quality development and validation of all statistical programming components.
• Produce and/or validate tables, listings, figures, and analysis datasets.
• Coordinate activities of internal/external programmers and make statistical programming decisions.
• Independently develop SAS or other programs for analyses.
• Manage the statistical computing environment.
• Work closely with Data Management and Biostatistics teams.
• Manage CROs and contractors.
• Collaborate with biostatisticians and clinical development colleagues.
• Identify issues and develop global tools to enhance efficiency.

Senior Manager, Statistical Programming

Clinical Research

• 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)

Director, Clinical Scientist – Respiratory

• Lead the Clinical Development Team (CDT) to deliver Phase 3 asthma studies
• Provide medical leadership and oversight for late-stage clinical trials in asthma
• Develop and refine clinical strategies and Target Product Profiles (TPPs) specific to asthma
• Serve as key author of late-stage clinical protocols, aligned with regulatory requirements
• Author clinical and scientific content for regulatory submissions (e.g., BLA, MAA)
• Oversee study design, protocol development, data review, and safety monitoring
• Perform medical monitoring for late-stage studies, ensuring patient safety, protocol compliance, and data integrity
• Serve as a member of the Safety Management Team (SMT)
• Manage oversight committees for late-stage asthma studies (e.g., DSMB, Endpoint Adjudication Committee)
• Collaborate cross-functionally with Clinical Operations, Regulatory, Biostatistics, and Pharmacovigilance
• Serve as primary medical contact for clinical sites, investigators, and CROs
• Interpret clinical trial data and contribute to study reports, regulatory filings, and publications
• Represent Generate at internal and external scientific and medical meetings
• Engage with external experts, advisory boards, and health authorities to support program goals

Senior Director, Clinical Development – Asthma

• Lead the Clinical Development Team (CDT) to deliver Phase 3 COPD studies
• Provide medical leadership and oversight for late-stage clinical trials in COPD
• Serve as key author of late-stage clinical protocols, aligned with regulatory requirements
• Author clinical and scientific content for regulatory submissions (e.g., BLA, MAA)
• Perform medical monitoring for late-stage studies, ensuring patient safety, protocol compliance, and data integrity
• Serve as a member of the Safety Management Team (SMT)
• Guide the development and optimization of COPD-specific clinical strategies and Target Product Profiles (TPPs)
• Lead protocol development, study design, and clinical data review
• Ensure safety monitoring and collaboration with cross-functional partners (PV, Regulatory, Clinical Operations, Biostats)
• Act as the primary medical contact for sites, investigators, and CROs
• Analyze clinical data and contribute to clinical study reports, publications, and regulatory submissions
• Represent Generate at scientific and regulatory meetings
• Interface with key opinion leaders, advisory boards, and regulatory agencies to support program advancement

Senior Director, Clinical Development – COPD

• 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
• Direct management and development of medical monitors and clinical scientists
• 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 manages late-state 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

• Serve as the clinical pharmacology and pharmacometrics lead on late-stage programs, driving PK/PD and exposure-response strategy from early clinical studies through pivotal trials and submissions.
• Design and oversee modeling and simulation plans to inform dose selection, trial design, and regulatory filings.
• Author and review key clinical pharmacology and pharmacometrics sections of INDs, BLAs, and related documents; participate in regulatory interactions as functional expert.
• Collaborate with cross-functional teams to integrate clinical pharmacology and pharmacometrics principles into clinical study designs, endpoints, and statistical approaches.
• Contribute to pediatric strategy development and submissions.
• Support the Head of Clinical Pharmacology in building scalable processes, standards, and systems that enable late-stage and global development.

Senior Director, Clinical Pharmacology

• Serve as the primary data management representative on cross-functional study teams
• Lead the development, review, and maintenance of data management documentation, including Data Management Plans (DMP), CRF Completion Guidelines, and Data Review Guidelines
• Oversee user acceptance testing (UAT) of eCRFs and associated edit checks
• Conduct data cleaning, discrepancy management, and data reconciliation activities with external vendors and internal stakeholders
• Review and monitor data quality metrics to ensure clean, consistent, and analyzable datasets
• Collaborate with CROs to manage timelines and deliverables for data management activities
• Contribute to database lock activities, ensuring audit readiness and data integrity
• Maintain and QC study-specific trackers and metrics dashboards
• Create and manage data deliverable timelines and tasks
• Review and provide feedback on vendor data transfer agreements, transfers and reconciliation
• Provide support to the Clinical Data Management Lead on study-related tasks and initiatives

Senior Manager, Clinical Data Management

• Responsible for the strategic leadership, operational oversight, and quality governance of the Trial Master File (TMF) process
• Serve as the subject matter expert (SME) for all TMF-related activities
• Oversee the eTMF system and all related processes
• Lead the creation and continuous improvement of Clinical Operations Standard Operating Procedures (SOPs)

Associate Director, TMF Management – SOP Development

• Set and lead the pharmacovigilance strategy and roadmap for Generate’s clinical and development programs.
• Ensure proactive risk management and compliance with local and international PV regulations
• Drives safety related content of regulatory submissions including reference safety information/IB, protocol, informed consent (DSURs, RMPs), and responses to health authorities
• Leads policy discussions to assure communication of benefit-risk considerations and safety surveillance activities including routine review of safety data to detect and evaluate safety signals.
• Oversee pharmacovigilance vendors and CROs to ensure consistent quality and inspection readiness.
• Build and evolve internal PV processes, systems, and SOPs in collaboration with Quality, Regulatory, and Clinical Operations.
• Collaborate cross-functionally with Clinical, Clinical Operations, Regulatory, and Biostatistics.
• Collaborates with medical to define risk-benefit profiles
• Serves as Generate's PV point of contact in regulatory meetings, inspections and internal audits.
• Serve as key member of safety governance committees, including presentation of safety issues, signal evaluations and proposed risk mitigation strategies.
• Mentor and grow a high-performing PV team, including the Sr. Director of PV and future leaders.

Executive Director – Head of Pharmacovigilance

• Serve as the clinical science lead across the respiratory portfolio, providing scientific and strategic leadership for early- and late-stage studies (asthma and/or COPD).
• Drive development and execution of clinical development plans (CDPs), target product profiles (TPPs), and end-to-end risk–benefit assessments.
• Design and develop clinical trial protocols and associated documents in collaboration with clinical development and operations leaders.
• Lead development of study plans, data review plans, and the clinical components of regulatory submissions (IBs, CSRs, briefing books, BLAs, MAAs).
• Partner with Biostatistics, Data Management, and Safety colleagues to ensure scientific rigor and regulatory compliance.
• Interpret clinical data and provide strategic insights to support decision-making and lifecycle planning.
• Guide oversight of data monitoring committees (DSMB, Endpoint Adjudication Committee) for late-stage studies.
• Provide strategic input into publication strategy and ensure timely delivery of abstracts, manuscripts, and presentations.
• Act as a senior representative with external stakeholders, including investigators, KOLs, CROs, and regulators.
• Lead, mentor, and develop a team of clinical scientists, fostering a high-performance, inclusive culture.

Senior Director, Clinical Scientist – Respiratory

• 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)
• Take ownership of clinical execution and ensure accountability to high standards of quality and rigor
• 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

• Design and deliver late-stage respiratory programs including asthma and COPD
• Lead a high-performing Respiratory Product Strategy Team (RPST) and set strategy for late-stage respiratory programs
• Recruit, mentor, and manage medical monitors, clinical scientists, and late-state clinicians
• Oversee protocol development, study design, medical review of data, and safety monitoring
• Collaborate with Head of Safety and PV to define risk-benefit profiles and ensure rigorous safety oversight
• Collaborate with Clinical Operations and CROs to deliver studies on timelines and within budget
• Oversee clinical/scientific content for regulatory submissions and interactions and serve as primary medical contact for regulatory bodies
• Guide interactions with external stakeholders including KOLs, advisory boards, investigators, and CROs
• Represent Generate externally at scientific, medical, and regulatory meetings
• Hold teams to high standards, build inclusive team culture, and promote enterprise thinking and cross-functional alignment

Vice President, Global Respiratory Products

• Lead the Clinical Development Team (CDT) to deliver Phase 3 asthma studies
• Provide medical leadership and oversight for late-stage clinical trials in asthma
• Develop and refine clinical strategies and Target Product Profiles (TPPs) specific to asthma
• Serve as key author of late-stage clinical protocols, aligned with regulatory requirements
• Author clinical and scientific content for regulatory submissions (e.g., BLA, MAA)
• Oversee study design, protocol development, data review, and safety monitoring
• Perform medical monitoring for late-stage studies, ensuring patient safety, protocol compliance, and data integrity
• Serve as a member of the Safety Management Team (SMT)
• Manage oversight committees for late-stage asthma studies (e.g., DSMB, Endpoint Adjudication Committee)
• Collaborate cross-functionally with Clinical Operations, Regulatory, Biostatistics, and Pharmacovigilance
• Serve as primary medical contact for clinical sites, investigators, and CROs
• Interpret clinical trial data and contribute to study reports, regulatory filings, and publications
• Represent Generate at internal and external scientific and medical meetings
• Engage with external experts, advisory boards, and health authorities to support program goals
• Hold teams to high standards for technical and collaborative performance
• Foster a high-performing, diverse, and inclusive team culture
• Promote enterprise thinking and strategic alignment across functions
• Communicate with clarity, courage, and empathy
• Model resilience, adaptability, and informed risk-taking

• Lead the Clinical Development Team (CDT) to deliver Phase 3 COPD studies
• Provide medical leadership and oversight for late-stage clinical trials in COPD
• Serve as key author of late-stage clinical protocols aligned with regulatory requirements
• Author clinical and scientific content for regulatory submissions (e.g., BLA, MAA)
• Perform medical monitoring for late-stage studies, ensuring patient safety, protocol compliance, and data integrity
• Serve as a member of the Safety Management Team (SMT)
• Guide the development and optimization of COPD-specific clinical strategies and Target Product Profiles (TPPs)
• Lead protocol development, study design, and clinical data review
• Ensure safety monitoring and collaboration with cross-functional partners (PV, Regulatory, Clinical Operations, Biostats)
• Act as the primary medical contact for sites, investigators, and CROs
• Analyze clinical data and contribute to clinical study reports, publications, and regulatory submissions
• Represent Generate at scientific and regulatory meetings and interface with key opinion leaders, advisory boards, and regulatory agencies
• Set high expectations for technical excellence, build and sustain a diverse high-performing team, align functional strategies, communicate transparently, and promote adaptability and smart risk-taking

Senior Director, Clinical Development, COPD

• Act as the lead data manager for assigned clinical trials from start-up through database lock.
• Review and implement data management documentation such as Data Management Plan (DMP), CRF design and CRF Completion Guidelines, edit check specifications, and data review and discrepancy management guidelines.
• Lead database build and UAT for EDC platforms (e.g., Medidata Rave).
• Drive data cleaning activities to ensure database quality and readiness for interim/final analyses including regular review of metrics, data issues and update slides for team meetings.
• Monitor data reconciliation activities with external vendors (e.g., labs, ECG) and Serious Adverse Events (SAE).
• Oversee CRO/vendor performance and ensure adherence to timelines and data quality expectations.
• Collaborate with cross-functional teams (clinical operations, biostatistics, safety, programming) to ensure alignment on data flow and delivery milestones.
• Create and manage data deliverable timelines and tasks; collaborate with CROs to manage timelines and deliverables for data management activities.
• Maintain and QC study-specific trackers and metrics dashboards.
• Support or lead database freeze/lock processes, including freeze/lock for final, statistical or interim reviews.
• Assist in departmental development, review, and revision of Data Management Standard Operating Procedures (SOPs), plans and guidelines.
• Recommend process improvements, tools, or automation opportunities to enhance data management efficiency.

• Report to the VP, Respiratory Products Leader and serve as medical lead for global COPD trials
• Lead the Clinical Development Team (CDT) to deliver Phase 3 COPD studies
• Provide medical leadership and oversight for late-stage clinical trials in COPD
• Serve as key author of late-stage clinical protocols aligned with regulatory requirements
• Author clinical and scientific content for regulatory submissions (e.g., BLA, MAA)
• Perform medical monitoring for late-stage studies ensuring patient safety, protocol compliance, and data integrity
• Serve as a member of the Safety Management Team (SMT)
• Guide development and optimization of COPD-specific clinical strategies and Target Product Profiles (TPPs)
• Lead protocol development, study design, and clinical data review
• Ensure safety monitoring and collaboration with PV, Regulatory, Clinical Operations, Biostats
• Act as the primary medical contact for sites, investigators, and CROs
• Analyze clinical data and contribute to clinical study reports, publications, and regulatory submissions
• Represent Generate at scientific and regulatory meetings and interface with KOLs, advisory boards, and regulatory agencies
• Provide leadership: set high expectations for technical excellence, build and sustain a diverse team, align functional strategies, communicate transparently, and promote adaptability and smart risk-taking