ImmunityBio, Inc.

Research Analyst

• Review of study-related materials including site initiation training slides, site specific informed consent form templates, procedures and laboratory manuals and development/procurement of applicable appendix documents
• Interpret medical and scientific intent of assigned study protocols and study procedures, logistics, risks to research subjects, safety, data evaluation methods to support review of study-related materials
• Track and maintain ImmunityBio study personnel list and training records for assigned studies
• Communicate study rationale for assigned studies to study team members and clinical sites
• Support Clinical Trial Manager (CTM) and Clinical Program Manager (CPM) with triage of clinical site inquiries regarding protocol interpretation and eligibility requirements
• Create/edit site feasibility questionnaire template, track feasibility/start-up activities
• Create regulatory document templates, oversee and support collection of essential documents during site start-up
• Review non-investigational product (non-IP) supply list from the CTM for research sample processing and shipment, review non-IP supply orders forms and work with Supply Chain (SC) for distribution to clinical sites
• File documents to the Trial Master File (TMF) and maintain expected document lists (EDLs) for study and country level documents and provide tracking and/or metrics throughout the study lifecycle as delegated by the CTM
• Communicate regularly with field Clinical Research Associates (CRAs) during site start-up and provide missing document list before the Site Initiation Visit and as needed for subsequent visits
• Partner with field CRAs and CTAs to resolve document issues identified during site visits
• Review investigational product (IP) metrics to ensure sites maintain sufficient quantities to properly conduct the trial as well as work with SC to ensure IP temperature monitoring excursions are documented and train or assist sites with corrective actions
• File documents to the TMF and maintain expected document lists (EDLs) for assigned site documents and provide tracking and/or metrics throughout the study lifecycle
• File documents to the TMF on behalf of functional groups that do not have access to the TMF as needed
• Perform content review and post approval review of documents filed to the TMF
• Provide approved study manuals and form templates to clinical sites in anticipation of Site Initiation Visit
• Support training of suppliers, investigators, and study coordinators on study requirements and provide guidance on site issues
• Conduct clinical specimen log review, track and coordinate shipment of specimens to the sponsor or contracted supplier
• Train sites on specimen and shipment requirements for central laboratory and serve as liaison with contracted suppliers, create and manage site shipping accounts
• Support supplier oversight including working with supplier quality group for supplier qualification and new vendor request process with finance and accounting
• Conduct remote monitoring tasks including reconciliation of site investigational product accountability
• Audit Investigator/Site invoices for accuracy and reconcile invoices against the case report forms (CRFs) and budget for payment submission, perform invoice reconciliation at site close-out
• Submit purchase requisitions to Enterprise Resource Planning (ERP) System for Clinical Operations and functional groups as needed. Request invoice approval from internal supplier designee(s).
• Work with accounting and finance to ensure activated clinical site record is added to the ERP System for site payment processing
• Provide data listings and compile clinical study report documents to support medical writing activities
• Create and/or review of slides, overheads, etc., for a project, departmental, sponsor and/or business development presentations
• Participate in clinical operations safety reporting activities including distribution to sites, tracking, IRB submission, TMF filing and completion of required form for updates to Safety Distribution System for site personnel or site status changes
• Submit clinical trial documentation to central IRB after initial submission by the CTM as needed
• Collaborate with other functional groups such as data management, pharmacovigilance, biostatistics etc. to ensure clinical trial activities are documented efficiently, compliant with regulations and standards, and aligned with project objectives
• Assist CTM with management of trial projects as delegated by the CTM
• Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities

Clinical Research Associate, In-House

Manager

• Execute sales strategy to drive Anktiva’s treatment adoption across all clinics and prescribers who treat and manage patients with approved indicators.
• Build trusting customer relationships and provide clear educational information to communicate efficacy results and define appropriate patient identification.
• Develop and maintain meaningful disease state knowledge and product expertise to provide value proposition to the customer.
• Analyze account performance, identify prescriber adoption barriers, and propose solutions to address barriers.
• Collaborate with ImmunityBio matrix partners to identify opportunities and/or change territory tactics.
• Accountable for the training of all relevant HCP’s on Anktiva dosing, administration, and overall treatment expectations for all accounts within the territory.
• Utilize approved resources to educate and answer questions regarding reimbursement and contracting information.
• Appropriately utilize company approved marketing tools and resources to craft a targeted approach to manage accounts and geographic territory.
• Plan, lead, and execute speaker programs for the top providers and clinics within the territory.
• Represent product in a professional, compliant, and ethical manner.
• Complete all administration, reporting, and training tasks proficiently and on time.
• Perform other duties as assigned.

Uro Oncology Business Manager

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
• 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
• 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

Area Business Director – West

• Own and execute enterprise-level strategies for assigned IDNs and large health systems to drive Anktiva adoption and utilization.
• Develop system-specific account plans that address clinical pathways, buy-and-bill economics, site-of-care optimization, and operational workflows.
• Identify and expand Centers of Excellence (COEs) and bladder cancer programs within health systems.
• Lead collaboration with Market Access and Contracting teams to identify and secure system-level agreements, rebates, and value-based arrangements.
• Support contracting strategies that align dose economics, utilization expectations, and payer mix realities.
• Provide leadership across internal teams to coordinate with Regional Sales Directors and field reps.
• Build trusted relationships with Health System executives (C-suite, service line VPs), Pharmacy & Therapeutics committees, and Urology, oncology, and bladder cancer leadership.
• Analyze system-level data to inform strategy.
• Lead Quarterly Business Reviews (QBRs) with key systems to demonstrate value, outcomes, and growth opportunities.

Health Systems Director

Medical Director

• Own the national Field Medical Director/Medical Science Liaison (MSL) organization (structure, headcount, territory alignment) and translate headquarters medical strategy into clear field objectives, KPIs, and tactics.
• Serve as the “voice of the field,” providing insights to Medical Directors and Medical Affairs leadership to influence medical strategy, launch plans and develop strategy.
• Directly manage, coach, and develop Field Medical Directors (hiring, onboarding, performance management, succession planning).
• Foster scientific acumen, soft‑skill development, and compliance awareness across the team.
• Ensure all field activities adhere to industry codes, company SOPs, and regulatory requirements (e.g., off‑label, unsolicited requests, safety reporting).
• Standardize documentation, insight capture, and CRM use; maintain high‑quality, compliant scientific exchange with key opinion leaders.
• Oversee identification, tiering, and engagement planning for key opinion leaders, aligning activities with the overall medical plan.
• Lead the national effort for thought‑leader engagement during pre‑launch, launch, and post‑launch phases.
• Partner with Medical Directors, Clinical Development, Health Economics and Outcomes Research (HEOR), Pharmacovigilance, and Commercial teams while preserving the non‑promotional nature of MSL.
• Represent field medical on advisory boards, congress planning, publication planning, and evidence‑generation initiatives.
• Create, edit and adhere to Standard Operating Procedures (SOPs), policies, and process improvements.
• Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.

Director, National Field Medical Director

• 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

• Develop, review, and update study-related training materials and documents including site initiation training slides, informed consent form templates, procedures manuals, laboratory and pharmacy manuals
• Interpret medical and scientific intent of assigned study protocols and study procedures, logistics, risks to research subjects and safety, data evaluation methods etc.
• Communicate scientific rationale for assigned studies to team members and clinical sites
• Serve as Subject Matter Expert for clinical sites including providing guidance on protocol interpretation and eligibility requirements
• Create/edit, distribute and collect site feasibility questionnaires
• Oversee and support collection of essential documents during study start-up
• Determine materials and other resources needed to conduct the clinical trial and manage their acquisition and distribution.
• Collect study and site metrics and maintain study trackers, as needed
• Conduct case report form (CRF) data review and review of source documents, work with sites to resolve data queries
• Communicate regularly with field Clinical Research Associates (CRAs) to provide information before and after site visits
• Partner with field CRAs and CTAs to resolve issues identified during site visits
• Work with Supply Chain to ensure sites maintain sufficient investigational product (IP) to properly conduct the trial as well as resolve IP temperature monitoring excursions and train or assist sites with corrective actions
• Train vendors, investigators, and study coordinators on study requirements and provide guidance on site issues
• Conduct clinical specimen log review, and coordinate shipment of specimens to the sponsor or contracted vendor
• Train sites on specimen and shipment requirements for central laboratory and serve as liaison with contracted vendors
• Conduct remote monitoring tasks including reconciliation of site investigational product accountability
• Provide data listings and compile clinical study report documents to support medical writing activities
• Create and/or review of slides, overheads, etc., for a project, departmental, sponsor and/or business development presentations
• Provide support and escalate issues to the Clinical Trial Manager (CTM) as appropriate.
• Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.

Clinical Research Associate I, Field Monitor

General Counsel

• Manage contracts from intake through execution by drafting, reviewing, and negotiating vendor agreements
• Serve as the primary legal support for procurement, business operations, and finance
• Collaborate with internal stakeholders to develop, update, and maintain standard agreement templates
• Identify and escalate higher-risk or non-standard issues
• Stay current with pertinent changes in legislation and regulatory environments

Contracts Counsel

Administration

• Provide all forms of contract-related support through all phases of the contract lifecycle
• Partner with a variety of key business stakeholders throughout the company
• Support team of attorneys working in a fast-paced environment on R&D, clinical trial and related agreements
• Complete templates to create initial agreement drafts based on intake forms
• Incorporate attorney comments into drafts and conduct final review of drafts prior to sending them to the other party
• Track contracts from intake, drafting, negotiation, approval and execution
• Manage draft control, running comparison of every round of negotiations and saving all drafts to working files
• Route contracts through the company’s required approvals process and facilitate electronic execution and finalization
• Perform routine follow-up on contracts in the negotiation process and attend weekly update meetings with clinical and operations teams
• Upload contracts and input relevant data into Company’s contract management repository
• Monitor, triage, and process group email inbox used for contract requests and questions
• Respond to questions and direct inquiries regarding contracts and other matters.
• Create and maintain contract reports.
• Adhere to Standard Operating Procedures (SOPs).

Senior Contracts Administrator

Sales

• Implement a clear framework of training goals and tactics to develop a best-in-class Field Sales Operations organization for on-boarding, initial sales training and advanced/on-going training and development
• Develop training curricula, state-of-the-art training tools, materials and related skills development programs to meet launch and brand training needs.
• Ensure an efficient and effective process for delivering training.
• Monitor the effectiveness of existing training and evaluate curricula and programs to determine overall effectiveness.
• Conduct regular training needs assessment activities, proposing and developing solutions to fill training gaps.
• Define and track KPIs for training effectiveness.
• Utilize sales data, assessments, and feedback to refine content, methods, and programs.
• Collaborate with analytics and brand team members to ensure training supports targeting, incentive plans and commercial priorities.
• Partner with HR on onboarding logistics and performance management objectives.
• Foster a learning environment based on adult learning principles that ensures optimal comprehension, development and retention.
• Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates as needed.
• Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.

Sales Training and Effectiveness Director

Analyst

• Generate, organize, deliver TMF performance metrics for various functional areas
• Support Trial Operations with the TMF implementation and throughout the study as needed with oversight by the designated Clinical Programs Manager(s) and Clinical Trial Managers CTM(s)
• Perform risk-based periodic reviews of quality issue responses and document quality reviews, as needed, on site, country, or study level or as delegated by Trial Maintenance Management
• Perform document review for suitability, content, legibility, and conformance with good documentation practices (GDP)
• Respond to or delegate TMF alerts, tasks, and quality issues as TMF Subject Matter Expert (SME)
• Raise quality issues for TMF issues found, as applicable
• Ensure similar documentation issues are handled uniformly across all trials/programs
• Exhibit knowledge of applicable FDA, ICH/GCP guidelines to perform review on documents that have been filed to the TMF and to support inspection readiness goals
• Participate in project specific meetings and educate functional leads in TMF requirements
• Ensure accurate completion and maintenance of TMF
• Demonstrate ability to make sound business decisions based on evidence (SOPs and guidance documents) and experience, deliver on commitments, share knowledge, acknowledge other achievements, and collaborate with peers in order to meet objectives or timelines in a rapidly changing environment
• Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities

Trial Master File Analyst

Compliance

• Develop, evolve, and administer ImmunityBio’s compliance programs to ensure compliance with all applicable laws, rules, and regulations.
• Drive a culture of ethical and compliant decision-making.
• Implement and oversee company-wide programs for Compliance monitoring, reporting, risk assessment, and remediation.
• Provide guidance and training, and conduct assessments in matters related to Compliance.
• Assist the Company’s Privacy Officer in implementing the global strategy and implementation of programs and policy focused on Privacy.