Overview

The Global Executive Director Medical Affairs will shape and execute the strategic vision for Shionogi’s anti-viral portfolio. This role provides critical medical leadership and strategic direction to ensure the successful development, launch, and lifecycle management of our anti-infective products. The Executive Director will collaborate cross-functionally to drive the development and launch of our products, and support their ongoing lifecycle management, ensuring they meet the highest standards of medical and scientific excellence.

Responsibilities

• Develop and execute global medical affairs strategies aligned with business objectives, regulatory requirements, and medical/scientific standards including the global 5-year scientific strategy for each global medicine, co-ordinate with GEE the resultant 5 year IEP and ensure IRTs, phase 3b/4, RWE and publications are consistent with the global strategy. 
• Provide leadership and guidance to the medical affairs teams at a global and regional level, fostering a culture of excellence, collaboration, and continuous learning. 
• Cultivate and maintain relationships with key opinion leaders, academic institutions, medical societies, and other stakeholders with global influence to advance scientific exchange and enhance scientific understanding. 
• Provide medical oversight for global data generation programs, including protocol design, investigator recruitment, and interpretation of study results. 
• Develop global scientific communication materials, including publications, presentations, and educational resources, to form the basis for materials used for science dissemination and medical education at a regional and local country level with the regional and country teams. 
• Ensure compliance with regulatory requirements and ethical standards in all medical affairs activities, including promotional and non-promotional interactions, where relevant globally. 
• Collaborate closely with cross-functional teams at a global, regional and local level, including clinical development, regulatory affairs, market access, and commercial teams, to integrate medical insights into strategic decision-making. 
• Build the global principles and foundations for medical education initiatives for internal stakeholders, including sales and marketing teams, to ensure a deep understanding of product profiles and therapeutic areas. 
• Maintain expertise in relevant therapeutic areas, staying abreast of scientific literature, clinical guidelines, and emerging trends to inform medical strategy and decision-making. 
• Manage the medical affairs budget effectively, ensuring optimal allocation of resources to support strategic priorities and deliverables. 
• Other duties as assigned.  

Minimum Job Requirements

Qualifications

• Medical Doctor (MD) or Doctor of Osteopathic Medicine (DO) degree with board certification in a relevant therapeutic area. Infectious Disease or Antiviral experience is strongly preferred.
• 12 years of experience in a pharmaceutical or biotech life sciences company required.
• 2+ years of Global Medical Affairs is required to include MA operational experience exp required

Competencies

• Collaborative mindset with experience in working seamlessly across geographies and functions, fostering partnerships and alignment on global initiatives.
• Strategic mindset, with the ability to think critically and develop innovative solutions to medical affairs challenges.
• Proven track record of developing and executing global medical affairs strategies for successful product launches and lifecycle management.
• In-depth knowledge of clinical trial design, interpretation of clinical data, and regulatory requirements.
• Ability to navigate complex regulatory environments and ensure compliance with relevant regulations and guidelines.
• Ability to navigate complex regulatory environments and ensure compliance with relevant regulations and guidelines.
• Strategic mindset, with the ability to think critically and develop innovative solutions to medical affairs challenges.
• Demonstrated ability to collaborate effectively in a matrixed, cross-functional environment.            
• Demonstrated understanding of global medical science and therapeutic areas, with the ability to critically evaluate data and stay abreast of international advancements.
• Proven leadership skills to inspire and develop high-performing teams across diverse cultural backgrounds, fostering a collaborative and inclusive environment.
• Strong leadership and team management skills, with the ability to inspire and motivate cross-functional teams.
• Excellent communication and interpersonal skills, with the ability to effectively engage with internal and external stakeholders.
• Strong business acumen to understand global market trends, optimize resources strategically, and ensure financial success on a global scale.
• Exceptional communication and interpersonal skills to navigate cultural nuances, build rapport, and influence stakeholders effectively in a global context. x         
• In-depth knowledge of global regulatory requirements and ethical standards, ensuring compliance across diverse regulatory environments. x         
• Collaborative mindset with experience in working seamlessly across geographies and functions, fostering partnerships and alignment on global initiatives. x         
• Commitment to upholding ethical standards and professionalism in diverse cultural settings, promoting a culture of integrity and compliance worldwide. x         

Other Requirements

• This position has significant managerial and decision-making authority.
• Ability and willingness to travel approximately 25% of the year both domestically and internationally
• Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ. Office presence required at least 50% of the time per month if the role will be in the U.S.

EEO

Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.It is the policy of Shionogi Inc. to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal, state, and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are, in fact, non-discriminatory.

If you are qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling 973-307-3550 or by sending an email to ShionogiHR@shionogi.com.