Generate Biomedicines

Director

• 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

Senior Director, Clinical Development – Asthma

• 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

Senior Director, Clinical Development – COPD

Vice President

• Accountable for designing and delivering late-stage respiratory programs, including asthma and COPD
• Reports directly to the Chief Medical Officer
• Recruit, mentor, and manage a team of physicians and scientists
• Lead a Respiratory Product Strategy Team (RPST) of cross-functional leaders
• Direct management and development of medical monitors and clinical scientists
• Develop high quality, ambitious development plans aligned with late-stage and corporate objectives and regulations
• 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 to timelines and budget
• Oversee protocol development, study design, medical review of data, and safety monitoring
• Prepare clinical/scientific content for regulatory submissions and interactions
• Serve as 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
• Hold teams to high standards, build diverse inclusive culture, promote cross-functional alignment and resilience

Vice President, Global Respiratory Products

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)
• Leadership responsibilities including mentorship, cross-functional collaboration, and ensuring high standards of quality and rigor

Senior Director, Clinical Development – Asthma

Senior Director, Clinical Development – COPD

Vice President, Global Respiratory Products

Director, Clinical Scientist – Respiratory