Medical Information and Communications Director

Company Overview
ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease.

Why ImmunityBio?
* ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
* Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.
* Work with a collaborative team with the ability to work across different areas of the company.
* Ability to join a growing company with professional development opportunities.

Position Summary

The Medical Information and Communications Director is a strategic position with a dual functional role that handles the development and review of high-quality scientific based medical information resources and operational oversight of both internal and external medical communications, congress planning, and independent medical education programming. This role collaborates extensively with internal stakeholders (e.g., Field Medical Directors, Medical Affairs Strategy, Regulatory Affairs, Pharmacovigilance, Clinical, Commercial Marketing teams) and external experts to ensure scientifically rigorous, compliant, and audience-tailored communications across ImmunityBio therapeutic areas of interest. The position keeps all Medical Information services and deliverables and ensures regulatory compliance across all activities. The role will ensure the highest level of evidence is provided to healthcare professionals and other stakeholders to support informed treatment and shared decision-making.

Essential Functions

Key Medical Information Responsibilities:

• Develops and manages ImmunityBio's Medical Information capabilities, including guidance to the call center and related processes and procedures.
• Develops and leads the execution of medical information plans for commercial and investigational stage products, incorporating labeled efficacy, safety, and related scientific information responses per regulatory requirements, industry standards and business needs.
• Responsible for aligning, implementing, and integrating systems, tools, technologies, and processes for medical information from an operations perspective, as it relates to inquiries from ImmunityBio's call center, while Medical Affairs Information updating written Standard Response and Custom Response letters for ANKTIVA (nogapendekin alfa inbakicept-pmln).
• Supports the review and development of scientifically accurate and fair-balanced medical materials for healthcare providers (HCPs), payers, and other formulary decision makers, including medical decks, evidence submissions, and medical response documents, including the composition of standard response letters (SRLs).
• Assures Medical Affairs | Legal | Regulatory approval for new SRLs; researches and writes custom responses.
• Oversees the development and routine evaluation of medical information inquiries and updating of medical information standard operating procedures (SOPs) and relevant other SOPs.
• Responds and/or resolves escalated inquiries from unsolicited consumers, health care professionals and other external customer requests for medical and safety information received via telephone, website/e-mail, and/or letter from the ImmunityBio call center.
• Manages databases and related systems of standard responses to track metrics across medical information resources used to proactively show medical information needs, insights and data gaps.
• Conducts regular literature searches and evaluate and interpret literature, proactively reporting insights and impact of key findings to Medical Affairs leadership - recommending compliant dissemination plans, when appropriate.
• Collaborates and communicates with Quality and Pharmacovigilance to ensure proper documentation and response to all safety related inquiries and adverse event reports in alignment with regulatory requirements.
• Collaborates with the Medical Affairs leadership, Commercial Training, and the relevant ImmunityBio departments to deliver periodic training on medical information processes, resources, and procedures.
• As appropriate, reviews and confirms eligibility with CCSIFM for current ImmunityBio clinical trial programs, and if applicable, connects patient/caregiver with appropriate clinical trial contact.
• Maintains subject matter expertise in ImmunityBio's disease areas, clinical and scientific data and competitor data.
• Adheres to company privacy policies, ensuring any confidential information or personal data and Data Privacy regulations.

Key Medical Communications Responsibilities:

• Represents Medical Affairs at both Promotional Review Committee (PRC) and Medical Review Committee (MRC) and actively takes part in the clinical review, editing, and approval for all company approved medical content for ImmunityBio' s marketed products.
• Formulates and provides accurate use of scientific information using approved labeling and company standard responses, published literature and other data.
• Develops medical communication deliverables to support medical education and scientific engagement including field medical slide decks, medical FAQs, brochures, and Medical Affairs related congress materials.
• Manages a comprehensive and organized literature repository (eg., EndNotes) for scientific evidence supporting marketed products.

• Manages and quality control medical affairs related content used for Medical Congress exhibiting and support of Commercial Exhibit operations for all TIER 1 scientific meetings and congresses.
• Supports Medical Affairs Leadership in planning for and reviewing Medical Education Grants and Sponsorships.
• Follows the Company's health and safety policies.
• Performs other duties as assigned.

Education & Experience

• An advanced scientific degree (PharmD, MD, or PhD) required.
• 10+ years of experience in the biotech, pharmaceutical, or supporting industry, including 6+ years in scientific communications and medical information required.
• Experience in handling direct HCP and patient communications (live calls), Medical Information inquiry tracking, Standard Response Letter (SRL) writing, and Medical Communication programming required.
• Experience with pharmaceutical Promotional Review Committee (Commercial, Medical, Legal, Regulatory) and Medical Review Committee (Medical, Legal, Regulatory) SOPs and technology platforms (e.g., VEEVA PromoMats, VEEVA MedComms) required.
• Prior experience in Oncology (e.g., Bladder Cancer, Prostate Cancer, Lung Cancer, Glioblastoma, Colo-Rectal Cancer) preferred

Knowledge, Skills, & Abilities

• Leading and developing all aspects of medical information capabilities.
• Ability to manage confidential and sensitive information with discretion and show good judgement, compassion, honesty, integrity, and build trust.
• Excellent verbal and written communication skills, in order to communicate with Key Opinion Leaders, patients, caregivers and Senior leadership team members within ImmunityBio.
• Ability to effectively communicate, collaborate and deliver scientifically accurate and fair balanced medical communication products in a fast-paced, and rapidly changing and dynamic environment.
• Working knowledge of medical terminology, pharmacology, regulations and industry compliance standards.
• Excellent customer-service orientation to communication with patients and caregivers who may be interested in clinical trials managed by ImmunityBio.
• Self-motivated, with initiative and the ability to take ownership of, and follow through with specific tasks.
• Proficient in Microsoft Office computer applications.
• Knowledge of HIPPA and other federal guidelines.

Working Environment / Physical Environment

• This position can work onsite or remote based on the candidate's geographic location.
• Regular work schedule is Monday - Friday [8am-5pm Pacific Time], within standard business hours; with occasional weekend work schedules as required by the business.Flexibility is available with manager approval.
• 10-15% travel (US and/or international).

This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location.

National Market

$162,000 (entry-level qualifications) to $180,000 (highly experienced) annually

Premium Market

$186,300 (entry-level qualifications) to $207,000 (highly experienced) annually

The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.

ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options * Health and Financial Wellness Programs * Employer Assistance Program (EAP) * Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability * Healthcare and Dependent Care Flexible Spending Accounts * 401(k) Retirement Plan with Company Match * 529 Education Savings Program * Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks * Paid Time Off (PTO) includes: 11 Holidays * Exempt Employees are eligible for Unlimited PTO * Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.

At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.