Senior Medical Director, Medical Affairs Virology/COVID-19

Overview :

The Senior Medical Director, Medical Affairs (Virology / COVID-19 ) will provide medical / scientific support for relevant Shionogi products by functioning as a medical subject matter expert. Will lead the strategic and tactical planning for relevant products, and represent Medical Affairs at various cross-functional team meetings.

This Senior Medical Director, Medical Affairs will have primary responsibility for the Virology / COVID-19 disease portfolio, with the flexibility to expand into other product areas as needed and as Shionogi Inc. continues to grow.

Responsibilities :

• Lead the US Medical strategy and tactical planning for virology / COVID-19 platform including pre-launch planning.
• Oversee and provide medical sign-off on all relevant product and disease state communications utilizing medical expertise and insight to develop and substantiate claim support.
• Serve as the voice of the therapeutic area by providing medical input to various commercial projects and initiatives, including the development of marketing materials and planning and implementation of strategic marketing activities.
• Through medical expertise and leadership, shape the development of Company documents, ensuring scientific accuracy in all educational materials, company communications and publications.
• Assist the VP, US Medical Affairs, and other members of Medical organization (e.g. MSLs) as is appropriate, with establishing and achieving medical affairs-related strategic goals and objectives.
• Collaborate effectively with the drug safety team members to optimize pharmacovigilance activities, including evaluation of reports of adverse events and monitoring of product labeling.
• Oversee Scientific Communication (Publications, CME / Education, Congress planning) with support from Scientific Communications leads.
• Drive the communication and collaboration of Medical plans with SHQ and SBV (where applicable)
• Lead key opinion leader (KOL) planning, including selection of outside experts, and maintain productive relationships with KOLs in relevant areas to the Companys business.
• Represent Shionogi Medical Affairs to key external stakeholders and organizations
• Partner with the Clinical Research team in the planning and review of Clinical Research programs, protocols and final study reports for clinical development projects, as well as in Clinical Research programs needed for the support of existing products and claims.
• Represent the Medical Affairs perspective in early stage project planning and recommend the most appropriate medical input for project development plans. Conduct early opportunity assessments and assist with regulatory submissions.
• Facilitate adherence to ICH, pharmacovigilance and GCP guidelines through the development and maintenance of applicable Company Standard Operating Procedures.
• Maintain effective working relationships with Development, Legal, Compliance, Regulatory, Pharmacovigilance, Marketing, and Medical colleagues and across regions.
• Maintain effective relationships with external experts / consultants to provide scientific support to the Companys business initiatives
• Participate in the Grant Reviews and Advisory Committees as needed / requested.

Minimum Job Requirements

Qualifications

Competencies

Other Requirements

Essential Physical and Mental Requirements

Disclaimer

The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice.

You acknowledge and agree that information described herein may be disclosed to applicable regulatory authorities, alliance partners and / or third party service providers as necessary for Shionogi to fulfil its obligations under applicable laws, including but not limited to compliance with regulatory inspections and / or audits.

EEO :

Shionogi Inc. is an equal opportunity / affirmative action employer.

All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, 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 in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.