Director, US Portfolio Medical Review
Director, US Portfolio Medical Review
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Salary Not Disclosed
1 Vacancy
Job Description
Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets led by VYVGART our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG and with the potential to treat patients across dozens of severe autoimmune diseases.
We are building a new kind of biotech company one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company our partnerships our science and our people because when we do we deliver more for patients.
The Director US Portfolio Medical Review will serve as a Medical Affairs member of the US Materials Review Committee (MRC) and Medical Materials Review Committee (MMRC). This position will report to the US Medical Review Community Lead.
The Director US Portfolio Medical Review will be a critical connector aligning communication operational execution and elevating the capabilities of our existing teams. This Role will responsible for above indication and/or molecule medical review to ensure consistency and harmonization in Medical Review across the argenx commercialized portfolio. This includes developing Medical Reviewer competencies by level through both individual and community based coaching.
ROLES & RESPONSIBILITIES
- Responsible for above indication and/or molecule medical review to ensure consistency and harmonization in medical review across the argenx commercialized portfolio and pipeline.
- Identifies and communicates above indication complex materials and lead preparation for indication Medical Review sub-team for level-up discussions
- Act as alternate Medical Reviewer to support any assigned indication due to peak volume or in the case of indication assigned reviewer absence.
- Identify gaps and develop internal scientific trainings to ensure Medical Review community is educated on scientific data relevant to MRC and MMRC materials across asset.
- Attend all relevant USMAEG MAEG Clinical meetings to keep abreast of scientific data for launched and peri-launch products.
- Support professional development of Medical Reviewers in conjunction with Medical Review Community Lead including identification of external training opportunities professional and scientific conferences.
- Identify and develop Medical Reviewer competencies by level (Mgr Sr Mgr AD) through both individual and community based coaching.
- Organize content and agenda in conjunction with Medical Review Community Lead for bi-annual medical review community live meetings.
SKILLS AND COMPETENCIES
- Ability to mentor a range of levels in Medical Review (Mgr Sr. Manager AD) in both hard and soft skills related to role including: critical evaluation of literature communicating with influence co-creation and Medical Review decision scope
- Communicates and collaborates effectively within Medical Affairs and cross-functional partners to cultivate a positive- solution oriented relationship
- Stay informed on industry trends regulatory requirements and innovations related to Medical Review.
REQUIREMENTS
- Doctorate Degree (PharmD/MD/PhD)
- Minimum of 10 years of experience in the pharmaceutical or biotechnology setting predominately within Medical Affairs or related roles.
- Direct promotional/medical review experience required including training various levels of Medical Review (8 years).
- Prior experience in above indication Medical Review and Subject Matter Expertise in the role of Medical Review.
- Preference for experience in leading a team in a Medical Affairs organization.
At argenx all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.
If you require reasonable accommodation in completing your application interviewing or otherwise participating in the candidate selection process please contact us at . Only inquiries related to an accommodation request will receive a response.
Required Experience:
Director
Employment Type
Full-Time
