Senior Medical Director, Medical Affairs - Remote (East Coast)
Company: ImmunityBio
Location: Culver City
Posted on: May 4, 2024
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
SummaryThe Senior Medical Director, Medical Affairs will be
responsible for Medical Affairs leadership in the successful
preparation and launch of pipeline assets as well as subsequent
lifecycle management activities. The position report to the Vice
President, Medical Affairs, and will play a key role in bringing
transformative therapy to patients in need. In addition, as the
Medical Affairs department is relatively new, this position will
contribute to the growth and development of the department overall,
bringing with them perspectives and experience that will set the
foundation for Medical Affairs within the company. This role
requires leadership capabilities within a matrixed environment as
well as a commitment to "rolling up one's sleeves" to get the work
done.Essential Functions
- Support the development and execution of a cross-functionally
aligned strategic Medical Affairs plan, inclusive of performance
metrics, to ensure successful product launch and subsequent
successful life cycle management
- Establish or strengthen professional relationships with the
medical and scientific community and compliantly exchange
scientific knowledge with global and regional thought leaders,
including 1:1 interactions, congress engagements, and advisory
boards
- Lead Late-Stage (phase 4) Clinical Development and expanded
access programs including leading the development of a
collaborative research strategy and co-chair of the Review
committee.
- Be a subject matter expert, sharing knowledge and providing
recommendations to functions as needed. In particular, collaborate
with the Clinical Development and Commercial organization to ensure
external-facing materials and presentations are scientifically
rigorous and clinically meaningful. Specifically, be a co-chair and
sign-off on Promotional Material Review Committee to assure the
medical accuracy and integrity of all marketing and sales
materials.
- Manage, mentor, and contribute to building the Medical Affairs
team to meet the needs of the organization
- Work with the internal teams to develop scientific narrative
regarding disease state, MOA, target product profile, and molecular
diagnostics
- Support the development and execution of a medical/scientific
communication strategies including a strategic, cross-functionally
aligned post-hoc analysis plan and publications.
- Present relevant medical data and lead discussions at
medical/clinical Advisory Boards involving Key Opinion Leaders or
Community-based physicians.
- Assess scientific/medical and educational needs across a
variety of external partners and subsequently develop the strategic
direction for support of ISTs and CME activities, including
chairing relevant review committees
- Directly or indirectly support team interactions with US health
payers to answer any questions about medical or clinical research
topics and supporting future inclusion of supported program in
their policies
- Medical Affairs lead for any program specific
collaborations
- Collaborate internally with clinical and regulatory departments
to support the planning, execution, and management of clinical
trial activities, including ensuring that appropriate institutions
and academic centers have opportunities to participate in clinical
programs.
- Support the Field Medical Science teams globally to provide
expertise, materials, and support as they engage with the broader
HCP community.
- Remain on the forefront of the relevant science and competitive
landscape
- Performs other projects and responsibilities as
requested.Education & Experience
- MD, Ph.D. or Pharm.D. Degree required. MD with a specialization
in Medical or Surgical Oncology or Urology preferred.
- Minimum of 3 years of clinical practice experience in specialty
field, which can include Fellowship training, or post-doctoral
research training.
- Minimum of 5 years of medical affairs or clinical research
experience within the pharmaceutical industry, CRO health-related
consulting company, or biomedical/clinical experience within
academia (or a combination of aforementioned) with a minimum of 3
years' experience in oncology or urology related fields.
- Demonstrated medical affairs experience required
- Launch experience preferred.Knowledge, Skills, & Abilities
- Ability to think innovatively about medical affairs strategy
and accurately anticipate future consequences and trends
- Demonstrated ability to lead by example and model collaborative
behavior by soliciting opinions, coupled with the ability to make
key decisions and be effective in getting the team behind the
decisions
- Excellent written and verbal communication skills
- Experience conducting formal presentations to Senior Management
and external opinion leaders
- Strong analytical skills, especially with regard to
understanding and interpreting scientific and clinical research and
literature, are essential
- Demonstrated self-starter and teammate with strong
interpersonal skillsWorking Environment / Physical Environment
- Fast-paced, dynamic, and collaborative environment
- This position works more than 50% from a remote home
office
- Includes at least 25% travelThis 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.$235,000 (entry-level qualifications) to
$270,000 (highly experienced) annuallyThe 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.
Keywords: ImmunityBio, Lynwood , Senior Medical Director, Medical Affairs - Remote (East Coast), Healthcare , Culver City, California
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