Clinical Research

• In collaboration with other members of the clinical research site team, works to support source document requirements for assigned studies.
• Creation of source documents that will follow GCP Guidelines and 21 CFR Part 11 Compliance in addition to internal SOPs.
• Create templates, worksheets, supplemental source for visits based on detailed review of protocol-defined exams, tests, evaluations, and assessments.
• Initial creation of source documents will use all available protocol specific documents (i.e., current IRB approved protocol, blank or annotated CRF, Sponsor provided source templates/worksheets, or reference manuals) to create a source document that is accurate and complete and to ensure that the source document is equipped to record all the required data for the visit.
• Creating, maintaining, updating, control, and release source documents, including paper and electronic source documents in line with the study protocol, and relevant sponsor guiding documents.
• Reviewing draft source and ensuring it is accurate and complete and to ensure that the source document is equipped to record all the required data for the trial.
• Coordinating initial source review and update process.
• Filing, maintaining, distributing, organizing, and archiving source documents for each clinical trial.
• Updating current source documents according to new clinical study protocol amendments.
• Activating studies and visits at the appropriate time.
• Supporting Quality Control (QC) of source documents before it goes to the users.
• Attending all relevant meetings to stay up to date with upcoming studies, progress on current studies, and studies closing out.
• Maintaining a single tracker for the department to track source document design activities and the status of the activities.
• Maintaining version control of all source documents.
• Managing daily communication with site staff and other internal departments.
• Remaining up to date with all assigned Clinical Study Protocol for study.
• Developing and maintaining excellent working relationships with internal and external clients to understand and meet their needs in line with company policies and procedures.
• Maintaining a positive, results-oriented work environment, building partnerships within the team and across the organization at large, and modeling teamwork.
• Participating in continuing education activities to maintain current knowledge of source document design and relevant software.
• Performing all other duties that may be requested or assigned.

Clinical Research Source Development Coordinator

• 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

• Provide scientific leadership and independent contribution to study design, protocol development, and clinical development planning
• Support the development, implementation, conduct, oversight, and reporting of clinical trials
• Perform comprehensive literature reviews and maintain current knowledge of relevant disease areas
• Participate in the review and interpretation of clinical data
• Collaborate cross-functionally with Clinical Operations, Data Management, etc.
• Draft and contribute to clinical and regulatory documents
• Support or lead scientific interactions with CROs, investigators, and external collaborators
• Develop and maintain productive relationships with external scientific experts

Clinical Scientist 2, Clinical Development

• Provide scientific leadership and independent contribution to study design, protocol development, endpoint strategy, and clinical development planning for assigned programs.
• Support the development, implementation, conduct, oversight, and reporting of clinical trials, ensuring scientific quality and alignment with program objectives.
• Perform comprehensive literature reviews and maintain current knowledge of disease areas, competitive landscape, emerging science, and regulatory developments relevant to assigned products and indications.
• Participate in the review, monitoring, summarization, and interpretation of safety, efficacy, pharmacokinetic, patient-reported outcome, and other clinical data to support development decisions and recommendations.
• Collaborate cross-functionally with Clinical Operations, Biometrics/Biostatistics, Data Management, Pharmacovigilance, Medical Writing, Regulatory, Translational Development, Medical Affairs, and other partners to support high-quality study execution and documentation.
• Draft, review, and contribute to clinical and regulatory documents, including study protocols, synopses, investigator brochures, clinical study reports, health authority submission content, briefing materials, abstracts, posters, and manuscripts.
• Support or lead scientific interactions with CROs, investigators, site personnel, and external collaborators to ensure consistency, scientific integrity, and effective study execution.
• Contribute to advisory boards, expert meetings, and other scientific interactions that support program development and evidence generation.
• Support the development of departmental processes, templates, standard operating procedures, and best practices as needed.

Clinical Scientist 3, Clinical Development

• Provide strategic HCC leadership, oversight and execution of the G lobal Health Care Compliance program for R& D, Clinical Research, Medical Affairs, and related activities.
• Act as a compliance partner and trusted advisor to G lobal R&D, Clinical Research and Medical Affairs teams, providing timely , practical guidance on clinical trials, investigator and site interactions, advisory boards, and scientific exchange.
• Assist in identifying , assessing, and mitigating compliance risks associated with clinical research activities and medical engagement models.
• Support compliance risk assessments, issue management, and monitoring activities related to R&D, Clinical Research and Medical Affairs.
• Collaborate with Legal, Privacy, Quality, Finance, and other assurance functions to deliver coordinated compliance support and risk mitigation.
• Contribute to the development, implementation, and maintenance of policies, procedures, and training materials related to R&D, Clinical Research and Medical Affairs compliance.
• Support responses to internal inquiries, audits, monitoring activities, and regulatory requests related to clinical and medical compliance topics.

Clinical Research Manager, Medical Affairs

• Managing and directing clinical research activities involving new or marketed drugs in the Oncology Clinical Research group and in the field of Thoracic Oncology.
• Managing the entire cycle of clinical development, including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meetings.
• Provide internal scientific leadership for cross-functional areas supporting clinical trials and interact externally with key opinion leaders.
• Evaluating pre-clinical and translational work for generating early clinical development plans and Investigational New Drug applications.
• Developing clinical development strategies for investigational or marketed agents that incorporate the latest scientific developments, regulatory requirements, competitive landscape, and commercial considerations.
• Planning clinical trials based on these strategies.
• Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed agents.
• Analyzing and summarizing clinical findings to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publications.
• Participation in internal and joint research project teams relevant to the development of new compounds and the further study of marketed compounds.

Distinguished Scientist, Clinical Research, Thoracic Malignancies

• 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

• lead the clinical trial strategy for multiple myeloma assets
• create synergies across Clinical Operations, Biostatistics, Regulatory, Translational Medicine, Project Management, New Product Planning and Pharmacovigilance
• author protocols, extended synopses, clinical sections of the Investigator Brochure, IND/IMPD fillings, annual reports
• provide expert medical guidance to other functions
• present and discuss development strategy and clinical study results with key stakeholders

Senior Clinical Research Director – Oncology

• Responsible for the development, execution and reporting of clinical trials in support of the registration of a product
• Development of abbreviated protocol and clinical protocol
• Participation in the review process for protocols, study reports, labeling, and interactions with regulatory agencies and ethics committees
• Drive breakthroughs that could turn the impossible into possible for millions
• Ensure that all development activities are targeted towards timely achievement
• Interact with opinion leaders and external consultants
• Serve as medical monitor for the studies assigned
• Ensure clinical data meets all necessary regulatory standards

Clinical Research Director – Immunology and Inflammation

• 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

• Provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies
• Collecting and organizing patient data
• Scheduling patients for study visits
• Performing clinical tests such as phlebotomy, EKGs, etc.
• Maintaining and updating data generated by the study
• Reviews proposals for compliance with sponsor and organizational guidelines; verify all sponsor requirements are met
• Verifies the accuracy of study forms and updates them per protocol
• Prepares data for analysis and data entry
• Documents patient visits and procedures
• Assists with regulatory binders and QA/QC Procedures
• Assists with interviewing study subjects
• Assists with study regulator submissions.

Clinical Research Coordinator – Multiple Sclerosis Imaging Lab

• Create the clinical development strategy for one or more assets and document it in the clinical development plan in collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing.
• Advance the CDP through internal management review.
• Leads a clinical subteam to design clinical studies and to create an abbreviated and full clinical study protocol.
• Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations.
• Review documents supporting clinical development such as Investigator’s brochure, regulatory documents for IND/CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval.
• Support drug registrations (contribution to submission dossiers label draft, regulatory response during the review process, Advisory Committee preparation).
• Contribute to data review, interpretation and publication of clinical study results.
• Represent Clinical Development at Health Authorities and incorporating advice into development strategy.
• Maintain or establish interaction with external scientific and clinical communities and to incorporate pertinent advice and learnings into the internal program.
• Align company position on clinical strategy with partner in alliance projects.
• Translate biology into clinic in close collaboration with research and translational medicine.
• Evaluate clinical aspects of business development opportunities as needed.
• Apply high ethical standards and work with integrity.

Clinical Research Director

• Lead biostatistics representation on project or study teams and provide statistical expertise.
• Define statistical methodologies, analyze data, and report results for clinical development plans.
• Train and supervise contract statisticians, ensuring quality deliverables.
• Assist in addressing statistical issues in regulatory, legal, or other challenges.
• Serve as a peer reviewer and internal consultant on broad statistical issues.
• Participate in process improvement initiatives and mentor new/junior biostatisticians.
• Conduct modeling and simulations as needed.
• Collaborate closely with study or project teams for data interpretation and reporting.
• Work with statistical programmers, data management, and vendors to deliver analysis results.
• Collaborate with medical writers to complete study reports and manuscripts.
• Supervise FSP statisticians in assigned tasks.

Senior Principal Biostatistician

• shape and execute clinical development strategy for assigned rare disease programs
• drive programs from early development through registration with a patient-centric focus
• serve as a recognized scientific authority within the Rare Disease TA
• lead design and authorship of study synopses, CDPs, and clinical sections of IDPs
• oversee end-to-end trial execution through cross-functional units, ensuring GCP and regulatory compliance
• define and manage timelines, budgets, and risk mitigation strategies
• serve as strategic clinical lead and medical spokesperson within the Global Project Team, Protocol Review Committee and Executive Leadership
• contribute to biomarker identification and provide due diligence support for business development opportunities
• drive timely publication of clinical data in peer-reviewed journals and at scientific congresses
• align cross-functional stakeholders around a unified development vision; present CDPs to governance and senior leadership
• mentor Clinical Research Directors and Clinical Scientists and contribute to talent development within the Rare Disease TA

Senior Clinical Research Director, Rare Disease

• Ability to phone screen patients or caregivers in caring and empathetic manner.
• Document patient information correctly in the computer database.
• Schedule/reschedule patient screen and prescreen appointments.
• Manage incoming calls from patients interested in taking part in research studies.
• Evaluate eligibility of potential subjects through methods such as screening interviews, reviews of medical records, or discussions with site clinic staff.
• Learn and maintain knowledge regarding clinical research studies including inclusion and exclusion criteria for different studies.
• Record contact status of patients and document information in the database.
• Review, call and update sponsor patient portals as needed.
• Perform all other duties that may be requested or assigned.

Clinical Research Patient Recruiter

• 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

Director, Clinical Scientist

• Executes statistical analyses plans independently
• Collaborates with project team members to implement the study design and statistical analyses plans
• Conducts review of administrative claims, electronic medical records, survey and clinical data
• Develops and implements prediction models for member and provider-based interventions
• Researches and analyzes broadly defined business scenarios, trends, and patterns
• Provides technical/analytical advice to staff
• Compiles results of studies for journal publication

Biostatistician – Health Services Research

• Support day-to-day medical monitoring, clinical development, data services, and pharmacovigilance for lead programs
• Collaborate cross-functionally with Clinical Operations, Regulatory, Biometrics, Translational Sciences, and Medical teams to ensure high-quality and timely study execution
• Perform ongoing review and interpretation of clinical data, including safety, efficacy, and longitudinal patient data
• Act as a primary contributor and owner of key clinical deliverables, including: Clinical study protocols, Investigator’s Brochures, Clinical study reports, and Regulatory submission documents
• Support clinical trial conduct and oversight, including data review, issue identification, and resolution
• Contribute to regulatory interactions and submissions, including preparation of FDA-facing materials and global regulatory documentation
• Partner with Clinical Operations to support patient enrollment strategy and execution

• Act as a mentor for other CRDs and Clinical Scientists on a same project/TA
• Collaborate with functions to ensure uniform, aligned operational approach
• Provide medical expertise to the clinical studies
• Support other clinical development activities
• Contribute to the clinical part of submission dossier for their projects
• Interact with other CRDs in the project, Global Project Head, The PV Rep, Regulatory and other key functional reps

Senior Clinical Research Director, I&I

• Planning and directing clinical research activities involving new or marketed medicines in the Atherosclerosis section of the Atherosclerosis & Metabolism therapeutic area
• Managing the entire cycle of late-stage clinical development and studies, including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication
• Evaluating pre-clinical and translational work for the purpose of generating early clinical development plans and Investigational New Drug applications
• Developing clinical development strategies for investigational or marketed Atherosclerosis drugs
• Planning clinical trials (design, operational plans, settings) based on these clinical development strategies
• Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Atherosclerosis drugs
• Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publications
• Participating in internal and joint internal/external research project teams relevant to the development of new compounds and the further study of marketed compounds
• Supporting business development assessments of external opportunities
• Supervising the execution of clinical studies
• Working closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects
• Assisting the Executive Director and/or Associate Vice President in ensuring that appropriate Corporate personnel are informed of the progress of studies of the company and competitors' drugs, and of internal and external expert opinions on scientific questions

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Clinical Research Source Development Coordinator

Clinical Trial Manager

Clinical Scientist 2, Clinical Development

Clinical Scientist 3, Clinical Development

Clinical Research Manager, Medical Affairs

Distinguished Scientist, Clinical Research, Thoracic Malignancies

Senior Clinical Trial Manager

Senior Clinical Research Director – Oncology

Clinical Research Director – Immunology and Inflammation

Director, Clinical Scientist – Respiratory Indications

Clinical Research Coordinator – Multiple Sclerosis Imaging Lab

Clinical Research Director

Senior Principal Biostatistician

Senior Clinical Research Director, Rare Disease

Clinical Research Patient Recruiter

Director, Clinical Scientist

Biostatistician – Health Services Research

Director, Clinical Scientist

Senior Clinical Research Director, I&I

Senior Director, Clinical Research – Atherosclerosis