Current Statistics
1,626,420 Total Jobs 259,563 Jobs Today 17,768 Cities 222,696 Job Seekers 146,729 Resumes |
|
|
|
|
|
|
Senior Medical Director, Medical Affairs - Remote (East Coast) - Culver City California
Company: ImmunityBio Location: Culver City, California
Posted On: 05/05/2024
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
|
|
|
|
|
|
|