Senior Medical Director Job Summary: The Senior Director, Global Medical Affairs will report to the SVP, Medical Affairs and Advocacy and will provide medical leadership for MIPLYFFA (NPC).
The role will be responsible for building and refining the medical affairs strategy as well as executing the tactical activities for MIPLYFFA (NPC) as well as future Zevra pipeline assets.
The ideal candidate will be a highly self-motivated, collaborative, scientifically-oriented, and accomplished Medical Affairs leader with a flexible, hands-on and team oriented style.
They will provide medical support and leadership to partners in field medical affairs, HEOR and evidence generation, marketing, sales, market access and payer engagement.
Key activities will include: establishing and leading the global medical strategy for MIPLYFFA , leading execution of relevant medical communications and engagement activities, supporting evidence generation, including support of expanded access programs, engaging with key opinion leaders, supporting payer-engagement strategy, compliantly supporting pre-commercial activities, and patient advocacy initiatives.
The position will be based in the United States.
Responsibilities: Develop, refine and lead the medical affairs strategy including data dissemination plan, scientific communications, congress planning, advisory board planning, medical education, publications planning, and payer engagementServe as the cross-functional medical affairs lead to support marketing, sales, advocacy, market access, and other collaborative planning and tactical execution across the companyMaintain high level of scientific and medical expertise in NPC and serve as key medical resource in the diagnosis, treatment and management of targeted disease areas and associated productsCollaborate closely with Field Medical Leadership to develop and support the successful execution of the field medical engagement strategy and ensure alignment with the product strategyLead/support the development of content and resources to support external engagement activities by the field medical affairs team and support/oversee the training of the team.Serve as the MIPLYFFA medical reviewer for abstracts, publications, disease-related and product related promotional materials and non-promotional scientific materials, including reimbursement dossiers and payer materialsLead and support clinical studies and evidence generation activities including Phase IV clinical studies, registries, and expanded access programsDevelop and communicate medical information and scientific communication content and key findings externally and within the companyProvide medical expertise to the commercial organization to compliantly assist in the development and execution of commercial activities, including trainingEnsure medical affairs compliance with all corporate, legal and regulatory requirementsCollaborate or serve on cross-functional global teams as directed by the SVP of Medical Affairs and AdvocacyHelp attract talent to the organizationCompetencies/skills: Developing and leading medical communications plans and deliverablesExpertise in rare diseases and rare disease drug developmentMedical affairs planning and executionBuilding and leading medical launch plansCross-functional engagement, support and collaborationEvidence GenerationKOL EngagementStakeholder managementEducation and Experience: Advanced degree in scientific discipline required (e.g., PhD, PharmD, MD)Strong strategic and business acumen as evidenced by at least 8 years in Medical Affairs, with at least 5 years building and leading medical affairs plans and supporting drug launchesPhysical Requirements: Prolonged periods of sitting at a desk and working on a computer.Must be able to lift fifteen pounds at times.
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