Senior Specialist, Regulatory Pharmacologist-Promotions

Company Overview
ImmunityBio is a vertically integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.

• 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 Senior Specialist Regulatory Pharmacologist - Promotions is responsible for the review and contribute to the approval of all US promotional materials and serve as the promotional regulatory consultant 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

• Contribute to the management of 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.
• Contribute to the proposal of creative, effective, and compliant regulatory strategies and solutions to challenging promotional concepts that meet business objectives and minimize regulatory risk.
• Contribute to 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.
• 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 assigned to support business needs and provide developmental opportunities.

Education & Experience

• Bachelor’s degree with an emphasis in science, health care or related fields with 7+ years of pharmaceutical/biologics industry or related experience with an emphasis in regulatory science or scientific disciplines (pharmacology/immunology/oncology) required; OR
  
• Master’s degree with an emphasis in regulatory science, health care or related fields with 5+ 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 regulatory science, health care or related fields with 3+ 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. Strong knowledge of pharmacology, immunology, or oncology, and related health authority regulatory requirements and guidelines is preferred.

Working Environment / Physical Environment

• This position will work onsite as noted in the offer letter.
• Regular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager approval
• Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
• This desk-based role involves close study of scientific and regulatory documents.
• This position will work closely with scientific colleagues throughout the day, often on a project team basis.
• Lift and carry materials weighing up to 20 pounds.

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.

$144,000 (entry-level qualifications) to $160,000 (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 uses artificial intelligence (AI) tools to assist with sourcing and identifying potential candidates for open positions. These tools help us reach qualified applicants and improve the efficiency of our recruitment outreach. No preference is given to applicants sourced or identified by AI tools.

Important: AI is not used to screen, evaluate, rank, assess, or make hiring decisions about applicants. All applications are reviewed by human recruiters and hiring managers. Hiring decisions are made solely by ImmunityBio personnel without automated decision-making.

We are committed to equal employment opportunity and ensure that all candidates are assessed based on their qualifications, skills, and experience through human review.

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.