Principal Regulatory Pharmacologist - Promotions

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 Principal Regulatory Pharmacologist – Promotions will report to the Director, Regulatory Pharmacology. The Principal Regulatory Pharmacologist is responsible for the review and approval of all US promotional materials and serve as the promotional regulatory expert interacting with marketing, legal, and medical teams and as a member of the promotional review committee to ensure that promotional practices are consistent with regulatory guidelines, our company's policies, and support business objectives. Essential Functions Serve as the liaison and manages correspondence with FDA’s promotional review divisions Office of Promotion and Advertising Review(OPDP)/Advertising and promotional labeling branch (APLB), including complex regulatory questions and submissions for advisory comments. Propose creative, effective, and compliant regulatory strategies and solutions to challenging promotional concepts that meet business objectives and minimize regulatory risk. Provide regulatory consultation in the development and implementation of US marketing strategy and promotional programs. Support the US commercial teams, including relevant stakeholders, by participating in strategy discussions and extended team meetings and providing regulatory guidance and perspective on marketing strategies and promotion objectives and tactics. Provide promotional regulatory input on concepts and draft materials to help ensure promotional materials are aligned with U.S. promotional regulations, corporate standards and policies and business objectives. Maintain current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters and policy issues affecting the pharmaceutical/biologics industry. Communicate significant changes in FDA perspective to relevant stakeholders Contribute to the development of departmental strategic initiatives to drive effective, compliant promotional regulatory review. Performs other special projects and duties as requested. Education & Experience Bachelor’s degree with an emphasis in science, health care or related fields with 10 years of pharmaceutical/biologics industry or related experience with an emphasis in regulatory or scientific disciplines required; or Master’s degree with an emphasis in science, health care or related fields with 8 years of pharmaceutical/biologics industry or related experience with an emphasis in regulatory or scientific disciplines required; or PhD or PharmD degree with an emphasis in science, health care or related fields with 6 years of pharmaceutical/biologics industry or related experience with an emphasis in regulatory or scientific disciplines required 3 years of direct experience as the primary reviewer of advertising and promotional materials required Knowledge, Skills, & Abilities Demonstrated knowledge of FDA regulations relating to advertising and promotion for prescription products. Demonstrated history of successful interactions with the promotional review divisions of FDA (OPDP/APLB) or experience developing/leading the regulatory strategy for a product filing/launch. Excellent verbal and written communication skills Attention to detail and ability to manage multiple priorities simultaneously. Strong interpersonal skills with ability to demonstrate strategic and analytical thinking Working Environment / Physical Environment This is a full-time on-site position (40 hours per week) Monday through Friday. This position may need to sit for long periods of time and use various computer programs. This desk-based role involves the close study of scientific and regulatory documents. This position will work closely with scientific colleagues throughout the day, often on a project team basis. 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. $173,000 (entry-level qualifications) to $197,000 (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. ImmunityBio is a leading registration-stage immuno-oncology and infectious disease company activating both the innate (natural killer cell and macrophage) and adaptive (T cell) immune system. We are developing molecular and product platforms including N-803, Aldoxorubicin, and a second-generation adenovirus vector, based upon our three key modalities of activating natural killer (‘NK’) and T cells, tumoricidal macrophages, and memory T cells. Please be aware of fraud or scams from individuals, organizations, and/or internet sites claiming to represent ImmunityBio in recruitment activities. We have an established recruitment process which is required for all posted positions by ImmunityBio prior to issuing an offer of employment. This ImmunityBio process requires formal interviews conducted live with personnel representing ImmunityBio and never requires payments or fees from job applicants. In the event that you receive a suspicious phone call, email or Linked InMail message about recruiting on behalf of ImmuntiyBio, unless it’s from an authorized recruiting associate, do not provide any personal information and never pay any fees. Qualified and interested candidates should apply to current openings directly through this ImmunityBio website. ImmunityBio accepts no responsibility for costs or charges incurred as a result of fraudulent activity.

Salary : $173,000 - $197,000