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

• Lead the US Medical strategy and tactical planning for COVID-19/Viral Diseases platform including pre-launch planning.
• Lead and develop a high-performing Medical Affairs team, ensuring clear priorities, strong execution, and consistent delivery of strategic objectives, while providing coaching, mentorship, and performance oversight to build individual and team capabilities.
• 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 Company’s 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 Company’s business initiatives
• Participate in the Grant Reviews and Advisory Committees as needed / requested.

Qualifications

• Medical Doctor or a Doctorate of Osteopathy degrees or PhD/PharmD level in biologic sciences.
• Minimum of 12 years relevant experience in a pharmaceutical company to include Supervisory responsibility for direct reports.
• Prior experience in Virology, Infectious Disease, COVID-19, or Vaccines is strongly preferred.
• Prior US launch experience in Medical Affairs strongly preferred.
• Experience interacting with Field Sales; MSL’s and KOL’s.
• Experience strategizing and overseeing development of publications and scientific communications.
• Willing to be flexible with regard to specific product responsibility.

Competencies

• Strong interpersonal, communications and presentation skills. Ability to effectively communicate with employees at all levels in the organization.
• Ability to be adaptive to switch therapeutic areas as deemed necessary.

Other Requirements

• Will travel to interact with field-based individuals - approximately 10-15% - domestic and international.
• Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ. Office presence required 50% per month, at least 2-3 days per week.

Additional Information

The base salary range for this full-time position is $280,000 - $350,000. Individual pay is determined by several factors, which include but are not limited to: job-related skills, experience, and relevant education or training. The range does not include the comprehensive benefits, bonus, long-term incentive, applicable allowances, or any additional compensation that may be associated with this role.