ImmunityBio, Inc.

Clinical Research

• Serve as the lead statistician for one or more clinical programs, overseeing all statistical aspects from study design through regulatory submission.
• Lead the design of all clinical trials including sample size calculations, interim analyses, DMC activities, and randomization procedures.
• Lead the development of clinical trial protocols and clinical study reports; write statistical methodology section of these documents.
• Develop and review statistical analysis plans (SAPs), including methodology, sample size calculations, and interim analysis strategies
• Guide and contribute to the creation, validation, traceability, reproducibility, and maintenance of the analysis datasets and statistical outputs.
• Lead the electronic submission of clinical trial data to regulatory authorities.
• Partner with clinical, regulatory, data management, and medical affairs teams to align statistical approaches with program objectives.
• Proactively solve problems of statistical complexity.
• Lead data standardization efforts (e.g., CRF and database design, edit checks, standard statistical programs, data presentations, data standards such as CDISC STDM/ADaM, and e-submissions).
• Communicate complex statistical concepts clearly to non-statistical stakeholders, including senior leadership and external collaborators.
• Participate effectively as a key member on clinical study teams.
• Provides analytical insight on statistical methodology and advice to internal teams of accordingly.

Principal Biostatistician

Brand Manager

• Assist in the development of product marketing strategy and implementation plans, including the creation of disease-specific messaging, initiatives, promotional materials, and promotional education programs
• Lead the Health Care Provider (HCP) strategy development and work with agency partners to execute omnichannel strategies for HCPs
• Lead the development for brand marketing planning and tools for market access as well as build the value story with the Market Access team to drive product growth in assigned segment (.e., Payor, Government)
• Create and execute a comprehensive, integrated tactical plan including digital initiatives to drive peer-to-peer education and awareness across hospitals and integrated delivery networks (IDNs) nationally and locally
• Partner with the Training Director to identify and develop product focused sales training
• Partner with Brand Director and data analytics team to develop materials, presentations, scorecards/measurements for internal and external audiences to articulate strategy, validate key metrics, and track execution, effectiveness and financial implications
• Assist in the management of the Promotional Review Committee (PRC) process by being the brand lead in process improvement with key internal stakeholders in Medical, Legal & Regulatory Affairs
• Cultivate and maintain strong relationships with local and national key opinion leaders (KOLs)
• Develop and maintain strong relationships with other functional areas and internal strategic partners (i.e. Sales, Promotional Review Committee, Medical, Regulatory Affairs, Clinical, Legal etc.)
• Play key role in managing agency and external vendor relationships
• Ensure marketing spend is tracking to target
• Perform ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities

Brand Marketing Associate Director

Manager

• Lead a team of Clinical Trial Managers, Clinical Research Associates and Clinical Trial Associates to meet the goals and timelines of the assigned therapeutic program.
• Act as the representative for program’s global clinical operations to functional group leaders, external vendors, and senior management.
• Partner effectively and synergistically with stakeholders across the entire company.
• Manage Clinical Trial Managers on day-to-day activities and strategic initiatives.
• Oversee the performance of designated team members, including interviewing, hiring and training employees, planning, assigning and directing work; coaching, mentoring, and conducting performance reviews.
• Performs other special projects and duties as assigned.

Manager, Clinical Programs

Software Engineer

• Lead all aspects of statistical programming activities inclusive of creation, validation, traceability, reproducibility, and maintenance of analysis datasets and statistical outputs.
• Contribute to and review statistical analysis plans and analysis datasets specifications.
• Prepare the electronic submission of clinical trial data to regulatory authorities.
• Anticipate statistical programming resource needs and work with management to ensure adequate long-term resource allocation within a project.
• Provide effective solutions for complex statistical programming tasks.
• Provide input or lead data standardization efforts (e.g., CRF and database design, edit checks, standard statistical programs, data presentations, data standards such as CDISC STDM/ADaM, and e-submissions).
• Create and manage project and study electronic subdirectories ensuring consistency in structure.
• Contribute to the design, creation, and validation of global programming macros that streamline programming activities and increase efficiency.
• Participate in development of new processes or revision of existing processes.
• Keep current with new statistical programming techniques and technical advancements.
• As necessary, provide work direction, guidance, mentoring, influence and support to junior staff.
• Train junior staff in more complex statistical programming techniques.
• Adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates.
• Perform ad-hoc and cross-functional projects assigned to support business needs and provide developmental opportunities.

Senior Statistical Programmer

• Lead and contribute to the design of phase I-III clinical trials including sample size calculations, interim analyses, DMC activities, and randomization procedures.
• Lead and contribute to the development of clinical trial protocols and clinical study reports; write statistical methodology section of these documents.
• Develop and prepare statistical analysis plans, statistical output shells, and analysis dataset specifications.
• Guide and contribute to the creation, validation, traceability, reproducibility, and maintenance of the analysis datasets and statistical outputs.
• Contribute to the electronic submission of clinical trial data to regulatory authorities.
• Proactively solve problems of statistical complexity.
• Provide input or lead data standardization efforts (e.g., CRF and database design, edit checks, standard statistical programs, data presentations, data standards such as CDISC STDM/ADaM, and e-submissions).
• Participate effectively as a key member on clinical study teams.
• Provides analytical insight on statistical methodology and advice to internal teams of accordingly.
• Keep current with new clinical trial designs and statistical methodology.
• As necessary, provide work direction, guidance, mentoring, influence and support to junior staff.
• Train junior staff in more complex statistical methodology.
• Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates.
• Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.

Senior Biostatistician

Director

• Lead, empower, and direct a field team of Uro Oncology Business Managers (BM)
• Design and implement short and long-term business plans intended to achieve commercial objectives and drive sales revenue with targeted accounts for their areas
• Achieve promotional objectives through execution management of specific marketing strategies and tactics for each BM
• Establish consistency in situational leadership principles with each team member to provide a trusting and productive working relationship
• Hire and coach team members for designated territory as needed
• Ensure forecast and quotas align, and sales compensation / incentive plans support growth
• Develop solutions to help address BM business challenges including barriers to appropriate product adoption
• Provide consistent, timely, and quantifiable BM performance feedback based on observations of key customer interactions and promotional tool utilization
• Clearly communicate and present all approved GPO and reimbursement resources
• Assess competitive promotional activity and treatment adoption from customers to share information and recommendations to leadership team
• Ensure sales teams have the needed data to maximize sales impact, and to refocus tactics and execution when indicated
• Develop key customer relationships through regular interaction, scheduled calls, industry events, and personal communication
• Partner with cross-functional commercial members to develop, implement, and manage the strategy and execution of the commercial launch
• Ensure all BMs are fully informed of ImmunityBio’s commercial compliance policy, all applicable federal and state laws, and guidance relating to product promotion
• Plan, forecast, and oversee an operating budget while actively monitoring expenses
• Represent product in a professional, compliant, and ethical manner
• Perform other special projects and duties as requested

Area Business Director

Program Manager

• Owns end-to-end delivery of assigned facility, utility, and equipment projects from concept through turnover to Operations, acting as the primary point of contact for scope, schedule, budget, and quality.
• Develops and maintains integrated program plans, including scope definition, milestones, resource plans, budgets, and risk registers for facility buildouts, renovations, and equipment installations.
• Coordinates internal resources and external partners (contractors, vendors, commissioning and qualification providers) to execute the program scope in a highly regulated environment.
• Leads regular project meetings, prepares status reports, and communicates progress, risks, and mitigation strategies to stakeholders and site leadership.
• Identifies critical path activities, dependencies, and potential bottlenecks; develops and implements recovery plans as needed to maintain project commitments.
• Plans, organizes, and directs a wide variety of capital projects including new construction, facility expansions, laboratory and cleanroom buildouts, and infrastructure upgrades.
• Partners with Facilities, Manufacturing, Quality, EHS, and external design teams to ensure facility layouts and building systems (HVAC, utilities, process piping, electrical, controls) meet operational, regulatory, and safety requirements.
• Partners with multiple project teams to ensure completion of all ongoing projects.
• Ensures design and construction are aligned with cGMP requirements for biopharmaceutical operations, including controlled environments, material and personnel flows, and segregation strategies.
• Monitors construction progress, reviews field changes, and assists in resolution of site issues; evaluates and recommends approval of change orders that impact scope, cost, or schedule.
• Leads or coordinates commissioning and qualification activities for new and modified equipment, utilities, and systems in partnership with Engineering, Validation, and Quality.
• Supports development and execution of CQV deliverables (URS, design reviews, FAT/SAT, IQ/OQ/PQ protocols, summary reports) to ensure equipment is fit for intended use and compliant with regulatory expectations.
• Ensures program and project timelines account for CQV activities, documentation reviews, and regulatory/QA approvals required for GMP release.
• Drives resolution of technical and validation issues during startup and qualification, coordinating cross-functional troubleshooting and escalation as needed.
• Ensures projects are executed in compliance with applicable building and safety codes, environmental regulations, and company standards.
• Partners with EHS to plan and monitor construction safety programs and ensure contractor compliance with site safety requirements.
• Supports internal and external audits/inspections related to facilities, equipment, and validation, including preparation and presentation of project and CQV documentation.
• Develops program and project budgets and cash flow forecasts; tracks and reports capital spend against approved funding.
• Reviews and evaluates vendor and contractor proposals, scopes of work, and change orders; provides recommendations for selection and award.
• Reviews invoices in line with completion milestones and contract terms.
• Facilitates cross-functional communication and decision-making to ensure alignment between Engineering, Operations, Quality, Supply Chain, and other stakeholders.
• Escalates key issues, risks, and decisions to leadership with clear options and recommendations.
• Prepares and delivers project updates to executive and site leadership, including dashboards, presentations, and written reports.

Program Manager – Engineering Projects

• Lead, empower, and direct a field team of Uro Oncology Business Managers (BM)
• Design and implement short and long-term business plans intended to achieve commercial objectives and drive sales revenue with targeted accounts for their areas.
• Achieve promotional objectives through execution management of specific marketing strategies and tactics for each BM.
• Establish consistency in situational leadership principles with each team member to provide a trusting and productive working relationship.
• Hire and coach team members for designated territory as needed.
• Ensure forecast and quotas align, and sales compensation/incentive plans support growth.
• Provide consistent, timely, and quantifiable BM performance feedback based on observations of key customer interactions and promotional tool utilization.
• Develop key customer relationships through regular interaction, scheduled calls, industry events, and personal communication.
• Plan, forecast, and oversee an operating budget while actively monitoring expenses.

Area Business Director – South Central

• Educate provider practices, including physicians, nurses, pharmacists, and clinical staff, on Anktiva’s mechanism of action, indication, patient selection criteria, and administration per the FDA-approved label
• Guide practices and health systems in operationalizing Anktiva within existing workflows, and/or establishing new processes and protocols to ensure successful operations
• Identify clinical and operational barriers to adoption and collaborate with internal teams to resolve them
• Teach provider offices how to create a Center for Excellence, specific to treatment with Anktiva
• Conduct in-person and virtual in-services on preparation, dosing, handling, and administration
• Serve as a trusted clinical resource for Anktiva-related questions and best practices
• Support providers in identifying appropriate patients consistent with the approved indication
• Assist care teams with aligning patient flow, documentation, and treatment logistics
• Partner with Sales to support customer needs while maintaining clear role boundaries
• Coordinate with Market Access and Operations teams to support site onboarding, access readiness, and reimbursement education
• Share field insights and best practices to inform training materials, tools, and process improvements
• Conduct all activities in accordance with company policies, FDA regulations, and industry standards
• Accurately document educational interactions, site visits, and implementation activities per internal requirements
• Perform ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities.

Clinical Implementation Director

• Responsible for managing the activities of several global clinical studies including assisting in the development of study-related documents, study site management, and patient data monitoring.
• Provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance.
• Assist Clinical Project Manager in the development and management of company-sponsored global clinical trials
• Lead in reviewing completed assignments by members of the clinical development group
• Lead/assist in the development and management of revisions to study-related documents such as the informed consent, laboratory manual, pharmacy manual, case report forms (CRFs) and other study execution tools.
• Provide support in site recruitment, site initiation, site payments and site close-out.
• Help to oversee the training of new clinical site staff or site training for protocol amendments.
• Liaise with the in-house team to ensure collection of updated regulatory documents as needed.
• Help to provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance.
• Lead/Assist in the training of clinical development group staff.
• Assist CPM to prepare and update clinical trial updates for Clinical Development team
• Provide support for summarizing and maintaining patient treatment, response and survival data for active studies.
• Other duties as assigned

Senior Clinical Trials Manager

• Managing the activities of several clinical studies
• Assisting in the development of study-related documents
• Study site management and patient data monitoring
• Providing guidance to clinical sites daily including protocol interpretation and protocol safety compliance
• Overseeing the training of new clinical site staff
• Liaising with the regulatory department for updated regulatory documents
• Preparing and updating clinical trial updates for Clinical Development team

Clinical Trials Manager

Data Scientist

• Create and/or review study-specific electronic or paper Case Report Forms (CRFs) using prior knowledge, protocol-specific information, and departmental standards.
• Work efficiently to incorporate core clinical team input and produce CRFs in a timely manner.
• Configure, migrate, and test electronic data capture (EDC) databases based on internal procedures, study requirements, and system best practices.
• Serve as a database manager for the study-specific clinical team, including the compilation of edit checks.
• Develop database requirements for use by EDC vendors.
• Serve as a study database manager and work with vendors to obtain deliverables in a timely manner.
• Create and/or review study-specific data management and database documentation, which may include: Data Management Plan CRF Completion Guidelines Coding Guidelines Annotated CRFs Edit Check Specifications.
• Attend study-specific team meetings and produce status reports and requested metrics, which may include query information or data trends.
• Perform data review and query generation/closure.
• Perform coding of verbatim terms such as adverse events and concomitant medications.
• Collaborate with medical scientists for coding, consistency, review, and approval.
• Incorporating coding files into the clinical database.
• Participate in the development of new processes or revision of existing processes.
• Train internal colleagues in clinical data management in either informal or formal settings as needed.
• Train Investigators and/or Study Coordinators at Investigator Meeting on the CRFs, the EDC system, and the CRF completion guidelines as needed.
• Provide data management expertise and support to the clinical teams using data management best practices.
• Provide analytical insight into data management strategies and advise the internal team with tactical strategies accordingly.
• As necessary, provide work direction, guidance, mentoring, influence, and support to junior staff.
• Train junior staff in more complex clinical data management processes.
• Adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates.
• Perform ad-hoc and cross-functional projects assigned to support business needs and provide developmental opportunities.

Clinical Data Manager

Operations

• Provide leadership to team members and study teams to ensure clinical trials are conducted in accordance with the protocols, Standard Operations Procedures (SOPs), Good Clinical Practices (GCPs), and other applicable regulatory requirements as well as management and mentoring of direct reports.
• Integrate monitoring activities with trial start‑up, site activation, and study close‑out processes, thereby creating a seamless end‑to‑end operational flow.
• Utilize negotiation, facilitation, meeting management, and conflict resolution skills to enhance cross-functional study team partnership and to ensure effective in-house clinical study team operations.
• Collaborate with trial execution leadership to ensure optimal resourcing of the study teams.
• Anticipate potential clinical operations process issues and influence and collaborate with the organization in adopting best practices, making recommendations for improvements, or leading development of new processes and continuous improvement of existing processes, tools, reports, and systems.
• Provide quality oversight of trial operations to contribute to inspection readiness.
• Own Clinical Operations Standard Operating Procedures (SOPs), responsible for review and revision or delegating duties as needed.
• Provide management support to the clinical operations team across all trials/programs by way of training, mentoring or review of study specific documents as needed.
• Collaborate with colleagues to ensure cross-team, site learnings, and best practices are shared.

Director, Field Monitoring Operations

• Create and/or review study-specific electronic or paper Case Report Forms (CRFs) using prior knowledge, protocol specific information and departmental standards.
• Work efficiently to incorporate core clinical team input and produce CRFs in a timely manner.
• Configure, migrate, and test electronic data capture (EDC) databases based on internal procedures, study requirements and system best practices.
• Serve as database manager for the study specific clinical team, including compilation of edit checks.
• Develop database requirements for use by EDC vendors.
• Serve as study database manager and work with vendors to obtain deliverables in a timely manner.
• Create and/or review study-specific data management and database documentation, which may include: Data Management Plan CRF Completion Guidelines Coding Guidelines Annotated CRFs Edit Check Specifications
• Attend study-specific team meetings and produce status reports and requested metrics, which may include query information or data trends.
• Perform data review and query generation/closure.
• Perform coding of verbatim terms such as adverse events and concomitant medications.
• Collaborate with medical scientists for coding, consistency, review and approval. Incorporating coding file into clinical database.
• Participate in the development of new processes or revision of existing processes.
• Train internal colleagues in clinical data management in either informal or formal settings as needed.
• Train Investigators and/or Study Coordinators at Investigator Meeting on the CRFs, the EDC system, and the CRF completion guidelines as needed.
• Provide data management expertise and support to the clinical teams using data management best practices.
• Provide analytical insight into data management strategies and advise internal team with tactical strategies accordingly.
• As necessary, provide work direction, guidance, mentoring, influence and support to junior staff.
• Train junior staff in more complex clinical data management processes.
• Perform other special projects and duties as requested.

Senior Clinical Data Manager

Recruitment

• Provide daily support of the full life cycle of attracting talent in a fast paced, high-energy environment while strengthening the organization’s image as an employer of choice
• Responsible for sourcing, screening and hiring candidates while building and managing talent pipelines
• Ensure compliance with ImmunityBio policies and processes and all federal and local regulations and laws
• Extend offers and work with team members to ensure the smooth and compliant onboarding of new hires
• Partner with all levels within the organization to provide Talent Acquisition solutions and services to the organization
• Provide guidance to Talent Acquisition team on compliance matters
• Conduct full cycle recruiting and hiring process for identified positions within ImmunityBio
• Ensure proper process administration in partnership with HR partners and hiring managers
• Develop passive candidate pipelines through innovative sourcing techniques and assist in implementing comprehensive sourcing strategies
• Perform searches using multiple online talent platforms and build talent pipelines while using creative recruitment techniques to find hidden prospects
• Conduct appropriate research of the industry and competitors for determination of qualified candidates
• Screen candidates using behavioral interviewing techniques and value-based methodology
• Develop compensation offers for positions using internal guidelines and consultation with hiring managers and the Total Rewards team
• Serve as back-up for coordinating the new hire orientation process, including scheduling the orientation, ensuring accurate new hire paperwork completion and creating the employee file
• Actively educate and participate in the training of hiring managers to ensure consistency of practices, adherence to federal and state regulations and laws and consistency across the organization
• Maintain a solid level of industry knowledge and a comprehensive understanding of the competitive landscape
• Serve as an ambassador of the employee experience
• Develop, maintain and adhere to standard operating procedures (SOPs)
• Perform ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.