Generate Biomedicines

Medical Director

• Serve as clinical science lead and core member of clinical development teams for respiratory studies
• Support day-to-day study execution and alignment with protocols, timelines, and regulatory requirements
• Design and develop clinical trial protocols and associated documents
• Develop clinical components of regulatory documents
• Review and interpret clinical data to ensure data quality, participant safety, and protocol compliance
• Participate in site selection, initiation, and ongoing engagement
• Track study progress, identify risks, and implement mitigation strategies
• Serve as scientific contact for CROs and vendors
• Collaborate with Clinical Operations, Regulatory, Biostatistics, Data Management, and Safety teams
• Contribute to governance meetings, study updates, data summaries, and risk assessments
• Maintain inspection readiness and support audits and inspections
• Support publications, abstracts, and manuscripts
• Contribute to TPPs, clinical development plans, and risk-benefit assessments
• Support oversight committees for late-stage asthma studies
• Mentor and coach team members where appropriate

Director, Clinical Scientist – Respiratory Indications

Clinical Operations

• Plan and execute early-stage clinical trials, initially focused on oncology programs
• Interface with internal and external stakeholders to plan, execute, and problem-solve throughout clinical trials
• Lead site- and CRO-facing interactions, including study start-up, drug and budget forecasting, and acquisition of high-quality clinical and translational data
• Serve as clinical operations program lead for at least one program and associated studies
• Lead a team of clinical operations staff
• Develop clinical operations strategy for assigned development programs
• Collaborate cross-functionally to develop protocols, annual safety reports, investigator brochures, clinical study reports, presentations, regulatory submissions, and publications
• Evaluate and select CROs, sites, and other external collaborators; develop vendor scopes of work, contracts, quality plans, monitoring plans, and budgets
• Develop and manage SOPs and ensure GCP compliance
• Evaluate vendor performance, troubleshoot challenges, and recommend solutions
• Develop and manage study timelines with internal partners
• Attend and present at study site initiation meetings and study calls as appropriate
• Plan and forecast patient recruitment
• Manage or mentor Clinical Operations team members

Associate Director, Clinical Operations

Clinical Research

• Serve as the lead data manager for assigned clinical studies and programs, developing and maintaining study-specific data management strategies, timelines, and deliverables
• Review and approve Data Management Plans, Data Validation Plans, edit check specifications, eCRF specifications, and database build documentation
• Provide hands-on oversight of Medidata Rave EDC database builds, including eCRFs, edit checks, custom functions, workflows, and related configuration
• Create, run, review, and interpret Rave reports and listings to support data review, cleaning, reconciliation, and oversight
• Plan, perform, and document testing of database builds, edit checks, eCRFs, derivations, and system functionality; identify defects, assess impact, track resolution, and verify fixes through UAT
• Lead data review, query management, external data reconciliation, and database lock activities, including oversight of CRO and vendor deliverables
• Monitor data quality, metrics, and study timelines to identify risks early; support external data integrations, transfer specifications, reconciliation activities, and inspection readiness
• Partner with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Pharmacovigilance, and external vendors throughout study conduct
• Provide updates on data management activities, risks, decisions, and timelines, and escalate issues as appropriate
• Review CRO financial reports, change notifications, and data management expenses for scope, budget, and timeline oversight
• Contribute to continuous improvement of data management processes, standards, tools, and templates

Senior Manager, Clinical Data Management

• Provide strategic oversight and end-to-end operational leadership for global Phase 3 studies and related development activities
• Translate program strategy into comprehensive, executable operational plans aligned with regulatory, scientific, and corporate objectives
• Own 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 on portfolio-level planning and decision-making
• Directly manage and develop Clinical Operations staff
• Recruit, hire, onboard, and retain talent
• Set performance expectations, conduct evaluations, provide coaching, and support career development
• Lead multidisciplinary study teams across Clinical Operations, Data Management, Biostatistics, Safety, Regulatory, Medical, Quality, and CMC
• Coordinate internal stakeholders, CRO partners, and external vendors
• Oversee global study startup, site strategy, enrollment execution, monitoring approaches, and patient engagement initiatives
• Ensure compliance with ICH-GCP, global regulatory requirements, and internal SOPs
• Oversee study budgets, vendor performance, and quality metrics
• Establish performance metrics and drive continuous improvement across external partnerships
• Lead inspection readiness strategy and support regulatory inspections
• Drive issue identification, risk management, and CAPA oversight
• Contribute to Clinical Operations strategy, infrastructure development, and process optimization
• Champion innovation in trial execution, including digital tools, decentralized approaches, and patient-focused strategies
• Share best practices and define standards across the clinical operations organization