ImmunityBio

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.. 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.. Delivers timely, accurate, and succinct clinical and scientific presentations to KEEs and HCPs, both proactively and in response to requests for information, consistent with promotional compliance, PhRMA guidelines, and FDA regulatory requirements.. Fulfill Pharmacovigilance responsibilities defined by ImmunityBio SOPs related to medical inquiries and drug safety information.. A minimum of 5 years of experience as a clinical/medical science liaison or related field- facing role, in the pharmaceutical or biotechnology industries is preferred.

medical director

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 Field Medical Director (FMD) is a field-facing representative of the Medical Affairs Department with a primary responsibility to engage in the exchange of scientific data and education of health care practitioners on ImmunityBio products and relevant disease states, and facilitation of clinical research. The FMD integrates clinical/scientific expertise and knowledge to ensure successful implementation of the medical affairs strategic plan within an assigned geographic region. The FMD brings relevant insights from the field on research developments, treatment landscape and new concepts in medical treatment. The role of the FMD is non- promotional in nature.
Essential Functions
Product/Therapeutic Area Support to External Stakeholders
Act as the primary clinical/scientific resource to Key External Experts (KEEs)/Health Care Practitioners (HCPs) in a specified geography for information pertaining to disease state and ImmunityBio's product(s) and pipeline to ensure awareness and understanding.
Provide high quality scientific information to healthcare professionals (HCPs).
Serve as a conduit for accurate and updated clinical, scientific, and medical information between External Experts (EEs)/investigators and the company's Medical Affairs and development groups.
Establish, foster, cultivate and maintain peer relationships with KOLs and HCPs in the therapeutic areas in which ImmunityBio has current and future interests.
Share knowledge and participate in scientific exchanges and interactions with identified KOLs
Delivers timely, accurate, and succinct clinical and scientific presentations to KEEs and HCPs, both proactively and in response to requests for information, consistent with promotional compliance, PhRMA guidelines, and FDA regulatory requirements.
Identify and report key scientific, clinical and research insights from key opinion leaders (KOLs) and HCPs to Medical Affairs for communication to key internal stakeholders.
Respond to unsolicited medical information requests in the field.
Fulfill Pharmacovigilance responsibilities defined by ImmunityBio SOPs related to medical inquiries and drug safety information.
In collaboration with manager, develop and implement the medical territory plan within geography.
Lead special projects such as development of training materials, training MSLs, mentoring MSLs, development of advisory board materials, facilitation and/or moderation of advisory boards, etc.
Training/Education
Develop, maintain, and demonstrate scientific expertise and a strong knowledge of oncology and disease states of interest to ImmunityBio, including the competitive landscape, ImmunityBio products and pipeline, clinical practice, and study methodology.
Demonstrate full knowledge of and ability to execute on approved medical strategies and MSL initiatives.
Serve as scientific subject matter resource to ImmunityBio commercial personnel and other internal stakeholders, as requested.
Research Support
In collaboration with Medical Affairs personnel support data generation Investigator- Initiated Trials (IITs) and HCP initiated projects.
Facilitate the review and follow-up of submitted IITs.
Support Clinical Development/Operations with ImmunityBio corporate sponsored trials as requested/assigned e.g., provide recommendations for site selection, present clinical data at site initiation, training, or investigator meetings, communicate insights from clinical sites internally to Medical Affairs and Clinical Development / Operations.
Professional Organization Support
In collaboration with internal ImmunityBio colleagues, support relationship development and interactions with professional organizations/societies & advocacy groups, GPOs, and large networked practices.
Collaborate with internal colleagues and HCPs on Medical Affairs initiatives including publications as requested, advisory boards, medical meeting support, medical education opportunities, training, speaker development, etc.
Health Economics and Outcomes Experience:
Develop relationships with Key External Experts as identified by Medical Affairs in collaboration with Market Access.
Identification of treatment pathways at key clinical sites.
Identification, internal communication, and execution of opportunities for evidence generation.
When assigned, deliver scientific and value presentations to health care decision makers (HCDMs), including, but not limited to, Managed Care Organizations (MCOs), specialty pharmacy providers (SPPs), group purchasing organizations (GPOs), pharmaceutical benefit managers (PBMs), and integrated delivery networks (IDNs).
Education & Experience
Advanced medical/scientific/clinical degree (MD, DO, PhD, PharmD, NP, and PA preferred) with experience in the pharmaceutical industry or related healthcare field required.
A terminal D degree (e.g., MD, PharmD or PhD) in medical or health sciences or equivalent is strongly preferred.
A minimum of 8 years of relevant therapeutic area expertise, in a scientific or clinical setting, in oncology, immunology, or other areas relevant to ImmunityBio's products and/or pipeline.
A minimum of 5 years of experience as a clinical/medical science liaison or related field- facing role, in the pharmaceutical or biotechnology industries is preferred. Experience in solid tumors is preferred and GU and Lung experience is strongly preferred.
Clinical trial experience is required.
Knowledge, Skills, & Abilities
Knowledge of treatment guidelines, clinical research processes, FDA regulations and OIG guidelines are preferred.
Excellent interpersonal communication and presentation skills are required.
Ability to network and partner with important external customers, including medical thought leaders, academic institutions, large group practices, medical directors and pharmacy directors is required.
Demonstrated ability and experience working cross-functionally.
Demonstrated ability to anticipate, organize, plan, and handle multiple changing priorities.
Demonstrated ability to work independently.
Demonstrated proficiency in communication at all levels of an organization.
Demonstrated ability to analyze complex situations and proactively identify opportunities/issues; effectively solve problems that cross-functional boundaries.
Demonstrated strong business acumen.
Ability to read, analyze and interpret scientific and technical information and data.
Individual should be able to apply critical thinking processes in order to optimize strategic initiatives and decision-making.
Requires operational proficiency with power point, word and excel.
Demonstrated ability to work with software tracking/logging systems, e.g., customer relationship management systems, insights capturing systems, etc.
Committed to the concept of team and working within the framework of the Medical Affairs Department, including as it pertains to compliance with policies, systems, and practices.
Possesses and maintains a valid driver's license.
Working Environment / Physical Environment
This a field-based position. The employee is required to set up a home-based office.
Capable of engaging in frequent business travel (approximately 50% of the time) including automobile, train, and air travel and ability to travel overnight and occasionally on weekends.
Domestic and international travel may include spending time at cancer trial sites/institutions, conference center, offices, and hotels.
FMD must live in the assigned territory.
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.
Salary Range: $190,000 (entry-level qualifications) to $240,000 (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 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.<br/><br/>Check you match the skill requirements for this role, as well as associated experience, then apply with your CV below.
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Remote working/work at home options are available for this role.

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