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Director, Global Medical Affairs ( Biologic )

Description The individual will provide medical/scientific strategic and operational expertise for core global medical affairs data generation activities including update of tralokinumab Investigator Initiated Study (IIS) Strategy, review of IIS s and competitive landscape analysis. The position holder will be a part of a global medical affairs team dedicated to tralokinumab. The advisor will collaborate with commercial team to provide medical input into commercial strategies, and will collaborate with Regional medical teams to ensure a successful global development and commercialization. Working together with Global core functions the position holder will be responsible for the systematic data gap analysis and the development of a data generation plan including  a Global Phase 3b/ 4 plan and IIS strategy for tralokinumab. Roles and Responsibilities: Updates to the Target Product Claims document based on Target Product Profile to reveal clinical data gaps and guide the Clinical Development Plan Identify clinical and pre-clinical data gaps and provide input to gap closing initiatives in the respective plans Updates existing Phase 3b plan and develops Global Phase 4 data generation strategy and tactics for tralokinumab in Atopic Dermatitis to ensure sustainable and differentiated profile Drives the global tralokinumab IIS strategy and reviews IIS's providing core medical/scientific strategic and operational expertise. Provides input to the medical strategic plans as responsible for the lifecycle plans and data generation plan as well as to the global business plans Expert reviewer of all study documents requiring medical input including but not limited to proposals, protocols, manuscripts and posters. Contributes, through medical expertise, to any appropriate external action with regulatory, pharmacovigilance, health economics, etc. Presents medical data at both internal and external meetings and training courses Training of internal and external stakeholders Acquires, maintains and expands knowledge and expertise in relevant medical-scientific areas in atopic dermatitis and eczema. Acquires and informs organization on competitive intelligence Provides expertise to support Leo Pharma's patient-centric approach, contributes to identification and investigation of unmet patients' needs Identifies global medical marketing needs, gaps and assists in establishing or strengthening medical affairs activities Ensures medical communication and interaction with external partners is appropriate Responsible for planning of selected medical affairs activities and manage assigned budget Completes all company-based and job-related training as assigned by LEO Pharma within the required timeline Additional duties as assigned by LEO Pharma Management Required Skills: Minimum of 10 years of professional experience, within the pharmaceutical industry and/or in clinical research Minimum of 5 years of experience in Medical Affairs Experience in working in a Global teams Medical degree or similar required, experience in dermatology preferred Good business/commercial understanding Track record of collaboration with commercial, legal, regulatory and medical communications Excellent understanding of the clinical development programs including compliance and regulatory requirements Leadership skills in a cross-functional global team environment Strong goal orientation, an ability to make decisions and a history of meeting deadlines and objectives Experience with developing and running Global Phase 4 programs. Experience in managing Key Opinion Leader relationships Experience working with biologics Skilled in developing, reviewing, understanding, and presenting clinical and scientific information to multiple audiences Excellent verbal, written communication skills and interpersonal skills. Must be able to perform all essential functions of the position, with or without reasonable accommodation Demonstrated cross-cultural sensitivity Ability to lead through influence Proactive and winning mindset Is highly organized, meets project deadlines and proactively delivers on business objectives Exhibits a culture of integrity, excellence, initiative and compliance Responsible for compliance with applicable LEO Policies and procedures Ability to travel up to 25% domestic and international
Salary Range: NA
Minimum Qualification
11 - 15 years

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