Generate Biomedicines

Medical Director

• Provide day-to day medical oversight for late-stage clinical trials in asthma and/or COPD ensuring patient safety, protocol compliance, data integrity and inspection readiness
• Serve as primary medical contact for clinical sites, investigators, and CROs Perform subject eligibility review, ongoing data reviews, manage study queries, identify and assess protocol deviations
• Serve as a member of the Clinical Development, Safety Management and Study Execution teams
• Contributing author and key reviewer of core clinical and regulatory documents including IB, ICF, RFI, study protocols, DSUR
• Support study oversight committees including DSMB, endpoint adjudication committee, etc.Collaborate cross-functionally with Clinical Operations, Regulatory, Biostatistics, and Pharmacovigilance
• Interpret clinical trial data and contribute to study reports, regulatory filings, and publications

Senior Director, Medical Monitor – Respiratory Indications

Clinical Research

• Serve as a day-to-day operational point of contact for assigned CROs and vendors, tracking study deliverables and timelines and flagging risks or delays to clinical operations leadership.
• Review CRO-generated study documents for completeness and quality, including monitoring visit reports, site correspondence, protocol deviations, and TMF entries.
• Support the coordination of study startup activities, including site activation tracking, regulatory document collection, and vendor kick-off preparation.
• Maintain and update study trackers, timelines, and action logs; ensure cross-functional teams have visibility into study status and open items.
• Attend and support cross-functional study team meetings; document meeting minutes, track action items, and follow up on outstanding deliverables.
• Track and triage protocol deviations reported by CROs; coordinate with vendors and internal teams to ensure timely documentation and resolution.
• Support safety reporting coordination, including tracking SAE/SUSAR notifications and ensuring timely distribution to sites and relevant stakeholders in line with vendor responsibilities.
• Monitor TMF completeness and support inspection readiness activities, working with CROs to resolve filing gaps and maintain document quality standards.
• Assist with IRB/IEC tracking across study sites, including monitoring approval status for amendments and annual renewals submitted by the CRO.
• Compile and distribute enrollment, site performance, and operational metrics to clinical operations leadership on a regular basis.
• Contribute to data reviews as needed, and track data cleaning progress performed by CRO.
• Review and track monitoring visits and monitoring visit reports performed by CRO to ensure high quality and adherence to the monitoring plan.
• Support vendor invoice review and budget tracking by reconciling CRO invoices against contracted activities and flagging discrepancies.
• Coordinate data reconciliation activities at key study milestones in collaboration with data management and the CRO.
• Support the onboarding of CTAs joining the study team and serve as a resource for day-to-day study questions.

Clinical Trial Manager

• 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 Director, Medical Monitor – Respiratory Indications

Clinical Trial Manager

Senior Clinical Trial Manager