Generate Biomedicines

Clinical Research

• 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.

Senior Clinical Trial Manager

• 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)

Director, Clinical Scientist – Respiratory Indications

• 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