Vice President, Medical Affairs

ImmunityBio, Inc. is a late-stage immunotherapy company developing 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.”

POSITION SUMMARY

The Vice-President of Medical Affairs (VPMA) oversees and manages the Company’s Medical Affairs department. With a strong commitment to achieving corporate objectives while maintaining the highest ethical, regulatory, and scientific standards, this individual will be responsible for the legally compliant execution of the Medical Affairs functions for FDA approved and commercialized Company products in the United States. The VPMA responsibilities will include, but not limited to; Medical Information, Investigator-Initiated Trial program, Medical Science Liaisons group, Medical Publications, Continuing Medical Education, Health-Economics Outcome Research (HEOR), Medical Advisory Boards and Medical Review of Commercial/Marketing Materials. The VPMA will set the vision and direction for the department, leading the team across multiple asset programs. Must be able to provide direction to senior leader’s cross-functionally and within the department.

The VPMA will be responsible for building and guiding a Medical Affairs function ahead of the organization's first commercial launch. This role provides strategic leadership and works closely with cross-functional leadership that includes Clinical Affairs, Regulatory, Commercial, Product, Engineering, and Data Sciences to ensure that the Medical Affairs scientific and medical strategies are aligned with broader corporate and medical community needs. Close collaboration will be needed with the global experts in each given field to ensure patient voice, clinical and value impact, and regulatory inputs are incorporated. The VPMA will direct a team of employees and/or vendors to accomplish the tasks. This position reports to the Chief Strategy Officer.

ESSENTIAL FUNCTIONS

• Will be responsible for creating, organizing, and recruiting qualified personnel to ImmunityBio’s Medical Affairs department.

• Will be responsible for creating and periodic maintenance/update of all Medical Affairs’ related SOPs and Guidance documents (eg-MSL Handbook, IIT Program Charter, Publication Policy, etc.).

• Will directly manage Medical Director(s) and functional leads as outlined in the M.A. organizational chart.

• Provides medical expertise, medical support and oversight and management to all Medical Affairs functions and reports.

• Ensures that the highest quality, scientifically and medically accurate, and fair-balanced medical data is contained in all Company generated commercial/marketing materials, scientific publications, medical information letters and responses, and other .A.M.A. materials.

• Provides medical review and final approval/rejection on all IIT proposals.

• Provides leadership and ensures the ethical, compliant, and scientifically excellent interaction and communication of .M.A. medical directors, MSLs, or other departmental employees with the external medical and patient advocate community.

• Works and communicates closely with commercial counterparts in the Company to assure appropriate medical affairs support to the Marketing & Sales organization.

• Interacts with staff across other functional areas to ensure the success of projects.

• Represents the Company to outside medical/scientific experts via participation in scientific congresses, medical advisory boards, discussions regarding IITs and other medical affairs-related activities.

• Keeps abreast of current medical/scientific progress and actively develops and maintains relationships with outside experts aligned with the scientific/medical objectives.

• Ensure the Company complies with all applicable regulatory and legal policies.

• Guide the development and alignment of Key Medical Objectives that will enable the larger Corporate Objectives

• Provide insight to pipeline determination in clinical feasibility and translate findings from research and medical community into clinical development opportunities.

EDUCATION/EXPERIENCE REQUIREMENTS

• Must possess an M.D. Must have completed Residency and Fellowship program in Hematology/Oncology or Urology.

• Must have at least a total of 10 years combined experience of clinical practice and medical affairs industry experience.

• Must have at least 5 years of industry medical affairs experience at the Medical Director or Vice-President level; and participated in the commercial launch of at least one oncology, hematology, or urology product in the U.S.

• Excellent and demonstrated interpersonal skills: the ability to understand and respond to multiple external and internal customers' demands, manage and handle conflict constructively required.

• Must have the ability to travel (20%)

REQUIRED COMPETENCIES – KNOWLEDGE, SKILLS, ABILITIES

• Must demonstrate ethical principles and behavior.

• Must have a strong working knowledge of oncology/hematology or urology and the regulatory requirements relating to medical affairs’ activities with ethical, legal, and regulatory standards.

• Demonstrated communication, writing, and interpersonal skills. Record of writing/preparing publications/presentations and presenting clinical information in a formal setting (eg-leading and presenting at Medical Advisory Boards, Scientific Congresses, etc.).

• Ability to work collaboratively in a team-based environment with minimal supervision.

• Working knowledge of introductory biostatistics.

• Vital planning and organizational skills; detail-oriented.

• Able to be hands-on and strategic.