BBOT

Clinical Research

• Support the Director in overseeing global clinical trial execution, including site activation, enrollment, monitoring, and closeout
• Support the Director in leading cross functional trial team meetings and ensure alignment on key deliverables, timelines, and risk mitigation strategies.
• Manage day-to-day operational activities for assigned studies, ensuring adherence to timelines, budgets, and quality standards
• Drive vendor integration strategies to ensure seamless execution between CRO, central labs, and any specialty service providers.
• Act as the main clinical operations point of contact for assigned study-level tasks, including managing CROs and vendors in collaboration with the Director
• Ensure completeness and inspection-readiness of the trial master file (TMF/eTMF)
• Support the development and maintenance of key operational documents including study manuals, ICFs, tracking tools, and monitoring plans
• Participates in the conduct of audits and support regulatory inspections related to GCP
• Monitor regulatory and GCP compliance across trial activities and support audit/inspection readiness
• Review clinical trial data listings to support identification and resolution of protocol deviations, data trends, and outstanding queries
• Own CRO and vendor oversight by tracking deliverables, proactively identifying risks until issue resolution, and performance metrics in partnership with the Program/Study Lead
• Oversee lab sample management processes, including sample tracking, shipment, reconciliation, and vendor coordination to ensure timely and compliant handling of biological specimens
• Contributes to continuous process improvement and SOP development
• Participate in team meetings, providing clinical operations insights and updates to internal stakeholders

Clinical Trial Manager – Senior

Medical Director

• Provides strategic and operational leadership for the Medical Writing function.
• Responsible for planning, development, and delivery of high-quality clinical and regulatory documents.
• Serves as a strategic partner to Clinical Development, Regulatory Affairs, Clinical Operations, and other cross-functional leaders.
• Responsible for establishing medical writing standards, building organizational capabilities, and ensuring portfolio-wide execution of medical writing activities.
• Develops and executes the Medical Writing functional strategy aligned with corporate and development objectives.
• Manages Medical Writing resource plans, including internal staffing, contractor oversight, and vendor management strategies.
• Establishes and maintains Medical Writing governance, standards, templates, and quality processes.

Director, Medical Writing

Research Analyst

• Execute in vivo pharmacology studies including preparation (e.g. ear tagging, shaving)
• Adhere to institutional SOPs and IACUC protocols
• Upload and manage experimental data in vivarium management systems and ELN
• Write study protocols and graph data using Prism
• Prepare formulation buffers and compound dosing solutions for small molecules

Pharmacology Operations Research Associate – Contract

• Lead the clinical pharmacology strategy for one or more oncology programs, ensuring alignment with regulatory requirements and scientific standards
• Design and oversee clinical pharmacology studies to support assigned oncology programs’ clinical development plans
• Collaborate with cross-functional teams, including clinical development and operations, biostatistics, and regulatory affairs, to drive the advancement of drug development programs
• Drive application of model-informed drug development (MIDD) approaches, including population PK/PD and exposure–response analyses
• Author relevant sections/modules of regulatory documents (including INDs, IBs, CTAs, IMPDs, NDAs, briefing packages, or other regulatory dossiers) and serve as subject matter expert in regulatory interactions with FDA and other global health authorities
• Interpret and communicate clinical pharmacology data and results to internal teams, health authorities, and external stakeholders
• Partner with biostatistics and data management to establish analysis datasets, statistical analysis plans, and reporting standards for PK/PD endpoints
• Contribute to dose selection and dosing regimen optimization across programs, leveraging exposure–response relationships and emerging clinical data
• Provide clinical pharmacology input into study protocols, informed consent forms, and clinical study reports
• Stay abreast of industry trends and advancements in clinical pharmacology and oncology, contributing to the scientific community through presentations and publications
• Participate in cross-functional team meetings, providing clinical pharmacology insights and updates to internal stakeholders

Director, Clinical Pharmacology

• Support the Director in overseeing global clinical trial execution, including site activation, enrollment, monitoring, and closeout
• Support the Director in leading cross functional trial team meetings and ensure alignment on key deliverables, timelines, and risk mitigation strategies
• Manage day-to-day operational activities for assigned studies, ensuring adherence to timelines, budgets, and quality standards
• Drive vendor integration strategies to ensure seamless execution between CRO, central labs, and any specialty service providers
• Act as the main clinical operations point of contact for assigned study-level tasks, including managing CROs and vendors in collaboration with the Director
• Ensure completeness and inspection-readiness of the trial master file (TMF/eTMF)
• Support the development and maintenance of key operational documents including study manuals, ICFs, tracking tools, and monitoring plans
• Participate in the conduct of audits and support regulatory inspections related to GCP
• Monitor regulatory and GCP compliance across trial activities and support audit/inspection readiness
• Review clinical trial data listings to support identification and resolution of protocol deviations, data trends, and outstanding queries
• Own CRO and vendor oversight by tracking deliverables, proactively identifying risks until issue resolution, and performance metrics in partnership with the Program/Study Lead
• Oversee lab sample management processes, including sample tracking, shipment, reconciliation, and vendor coordination to ensure timely and compliant handling of biological specimens
• Contributes to continuous process improvement and SOP development
• Participate in team meetings, providing clinical operations insights and updates to internal stakeholders

Clinical Trial Manager, Senior

• Provide data management input for clinical study teams and the Development department
• Represent and communicate data management activities, progress, and risks to cross-functional leads
• Lead and manage clinical data management tasks and activities for assigned clinical trial(s) from study start up to study closeout
• Manage and provide oversight of vendors (including clinical data management CRO) to ensure the data are complete, accurate and delivered within the agreed upon timelines, including timely filing of all DM related plans and documents to eTMF
• Oversee Data Management functional budget and perform budget review for outsourced data management activities
• Ensure inspection readiness by maintaining current documentation, adherence to industry guidelines, SOPs and compliance with training
• Work collaboratively with internal and external team members within the study to coordinate the planning and execution of clinical data management activities and data deliverable timelines in support of overall clinical development strategies
• Create strategies for rapid study start and database lock to increase clinical data management productivity
• Oversee CRO EDC database build and lead the design of eCRFs and ensure that they align with the clinical protocol(s)
• Ensure complete and accurate documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, data validation specifications, data transfer agreements, and data management plans
• Ensure data is reviewed on an on-going basis, including individual subject data within the EDC, datasets, TLFs, etc. that are generated for Regulatory Agency interactions, CSRs, DSURs, IBs, and other business needs; collaborate with programming to identify data cleaning gaps to create additional line listing outputs and facilitate internal medical line listing review / issuing and resolving queries
• Collaborate with clinical development team and provide expertise regarding CDISC data standards, FDA and ICH guidelines, and GCDMP standards
• Help establishing CDM processes and contribute to the development of key clinical data management SOPs
• Provide technical support and guidance for clinical data management team and vendors around project conventions, standards, practices, and database specifications

Director, Clinical Data Management

• Serve as trial medical lead/medical monitor of assigned clinical studies, including contributing to site selection, study oversight and management plans, CRF design, ICF, enrollment, medical data review, CSR writing, and authoring of clinical modules and clinical review of other modules
• Be a leader within and actively participate and contribute to the cross-functional and project teams meetings, including functioning as clinical representative
• Cultivate relationships with clinical investigators, clinical consultants, and thought leaders for the execution of ongoing trials and developing opportunities
• Help ensure Clinical Study Team compliance with ethical and GCP guidelines, and FDA, EMEA, ICH, and other regulatory requirements relevant to industry/country/region
• Provide expert support for the preparation of clinical/study protocols and amendments, clinical trial documents
• Responsible for the clinical sections of regulatory documents (investigator brochures, development safety update report, etc), clinical study reports
• Conduct investigator meetings and lead site initiation visits with clinical trial investigators
• Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets
• Translate findings from research and nonclinical studies into clinical development opportunities
• Contribute to the clinical portions of writing and preparation of abstracts, presentations, and manuscripts
• Attend key scientific congresses and meetings as requested in support of speakers and key opinion leaders
• Remain current in relevant therapeutic areas and conversant with the literature as well as critical emerging data
• Represent the Clinical Development team during interactions with regulatory agencies, as applicable