Vice President, Chief Compliance Officer

Job Description

ImmunityBio, Inc. is a late-stage immunotherapy company developing a broad pipeline of next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious disease. The company's immunotherapy platform is designed to activate both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term "immunological memory." The U.S. Food and Drug Administration (FDA) has accepted for review ImmunityBio's resubmission of its Biologics License Application (BLA) for N-803, a first-in-class IL-15 superagonist, plus Bacillus Calmette-Guerin (BCG) for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 disease, and has set a user fee goal date (PDUFA date) of April 23, 2024.

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 an early-stage public biopharmaceutical company with a headquarters in Southern California.

* Work with a collaborative team with the ability to work across different areas at the company.

* Ability to join a growing company with development opportunities.

Position Summary

The Chief Compliance Officer will be responsible for developing, evolving, and administering ImmunityBio's compliance programs to ensure compliance with all applicable laws, rules, and regulations. Reporting to the General Counsel, the Chief Compliance Officer will drive a culture of ethical and compliant decision-making. The Chief Compliance Officer will implement and oversee company-wide programs for Compliance monitoring, reporting, risk assessment, and remediation, and will provide guidance and training, and conduct assessments in matters related to Compliance. The Chief Compliance Officer will also serve as the Privacy Officer and will be responsible for the global strategy and implementation of programs and policy focused on Privacy in collaboration with Quality and Information Security teams, including leading privacy reviews, regulatory monitoring, and incident response.

This position will require hands-on leadership, building relationships and counseling business, commercial, clinical, medical affairs and legal teams and advising on compliance with global regulations, counseling on privacy implications for products and services, and participating as a leader in the Legal organization sharing best practices, knowledge, and resources across the internal community.

Essential Functions

  • Establish and direct ImmunityBio's global Compliance strategy for the company by identifying and assessing Compliance risks in partnership with senior management.
  • Provide guidance to senior management regarding the overall development and implementation of the Compliance Program to mitigate Compliance risks.
  • Establish and direct periodic risk assessments and conduct related ongoing monitoring activities of the Compliance Program, as well as keeping abreast of industry and enforcement developments, and update the Compliance program when necessary.
  • Provide training to employees and consultants (as applicable) of ImmunityBio to ensure understanding of responsibilities with respect to Compliance issues. Create and present compliance training content and ensure all Compliance training requirements are communicated to and implemented by all such constituents.
  • Oversee matters reported through the company's Helpline and develop and implement an effective program for routine monitoring and auditing of adherence to Compliance policies and procedures; identify potential areas of compliance vulnerability and risk, and opportunities for enhanced training, and develop and implement corrective action plans as necessary.
  • Investigate allegations of violations of policy or misconduct; conduct/coordinate investigations; communicate findings to the appropriate senior leadership and Board, as necessary. Establish in collaboration with HR appropriate disciplinary action for confirmed violations.
  • Responsible for evolving privacy and data protection strategy, including developing and communicating policies and practices, performing risk assessments, monitoring ongoing compliance, and collaborating with the Information Security team to ensure compliance with relevant regulations.
  • Partner with Quality and Information Security to implement privacy and data controls and lead Privacy and data incident response preparedness, including evolving and practicing the Company's Privacy and data incident response plan.
  • Prepare and present materials to the Board and/or Board committees as requested regarding the Company's Compliance Program.
  • Perform such other duties and responsibilities on various corporate initiatives, transactions and strategic projects as requested by the General Counsel or other members of senior management.

Education & Experience

  • Bachelor's degree from an accredited university
  • Juris Doctor (J.D.), with active membership in a Bar Association.
  • 10+ years of relevant Compliance and Privacy experience in the healthcare industry, with in-house experience in the life-sciences industry preferred.
  • Experience building best-in-class Compliance programs
  • Proven track record of identifying, raising, and solving challenging Compliance and ethics issues.

Knowledge, Skills, & Abilities

  • Deep knowledge of the global Compliance laws, regulations and other requirements
  • Demonstrated success in strategic business partnering across multiple internal and external constituencies. Proven ability to build consensus while mitigating risk.
  • Extensive knowledge of local, state and federal laws
  • A team player in the truest sense of the phrase; someone who is solutions-oriented and collaborative, able to roll up their sleeves and work effectively with all levels in the organization as well as external parties.
  • A strategic thinker and excellent communicator-both verbal and written-with executive presence, collaboration skills, and the ability to consistently meet or exceed project deadlines.
  • Ability to lead others, as well as lead and manage multiple projects, while remaining organized and delivering successfully in a fast-paced, evolving environment.
  • Ability to independently identify, analyze, and render legal advice on complex business issues and general corporate matters.
  • Must be a strong collaborator and adept at understanding the motivation and needs of others and effectively communicating with a diverse audience, including senior leaders, in a manner that generates confidence and support for legal recommendations.
  • Strong people-management skills with a team building mindset.
  • Strong internal and external customer service mentality and sense of urgency.
  • Ability and interest in developing expertise in new, complex subject areas.

Working Environment / Physical Environment

  • In-person role at one of the Company's Southern California office locations (El Segundo, CA or San Diego, CA)
  • Occasional business travel will be required

This position is eligible for a discretionary bonus and equity award. The 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.

$320,000 (entry-level qualifications) to $375,000 (highly experienced)

The application window is anticipated to close on 3/25/2024 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 mandatory vaccination employer for COVID-19 and its variants. The Company requires that its employees be fully vaccinated as of their start date. If you require a medical or religious accommodation we will engage in the interactive process with you. Proof of vaccination will be required prior to start. If we make you an offer and you are not yet vaccinated, we will accommodate a delay in start date. ImmunityBio may also mandate that its employees receive vaccine boosters, and all accommodation laws will be followed.

 

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