Senior Director Medical Affairs (COVID-19/Viral Diseases)

About the role

Provide medical and scientific support for Shionogi’s COVID-19 and viral-disease products as the subject-matter expert. Lead strategic and tactical planning, represent Medical Affairs on cross-functional teams, and oversee the COVID-19/Viral Diseases portfolio with flexibility to expand into additional product areas as the company grows.

Responsibilities

• Lead US Medical strategy and tactical planning for the COVID-19/Viral Diseases platform, including pre-launch activities.
• Build and develop a high-performing Medical Affairs team, setting clear priorities, ensuring strong execution, and delivering strategic objectives while providing coaching, mentorship, and performance oversight.
• Oversee and provide medical sign-off on all product and disease-state communications, ensuring scientific accuracy and substantiated claim support.
• Serve as the therapeutic-area voice by providing medical input to commercial projects, including marketing materials and strategic initiatives.
• Shape the development of company documents, ensuring scientific accuracy in educational materials, communications, and publications.
• Assist the VP of US Medical Affairs and other Medical Affairs members (e.g., MSLs) in establishing and achieving strategic goals.
• Collaborate with the drug safety team to optimize pharmacovigilance activities, including adverse-event evaluation and product-labeling monitoring.
• Oversee Scientific Communication (publications, CME/education, congress planning) with support from Scientific Communications leads.
• Drive communication and collaboration of Medical plans with SHQ and SBV (where applicable).
• Lead key opinion leader (KOL) planning, including selection of external experts, and maintain productive KOL relationships.
• Represent Shionogi Medical Affairs to external stakeholders and organizations.
• Partner with the Clinical Research team in planning and reviewing clinical research programs, protocols, and study reports for development projects and existing products.
• Represent the Medical Affairs perspective in early-stage project planning and recommend appropriate medical input for development plans.
• Conduct early opportunity assessments and assist with regulatory submissions.
• Facilitate adherence to ICH, pharmacovigilance, and GCP guidelines through development and maintenance of company SOPs.
• Maintain effective working relationships with Development, Legal, Compliance, Regulatory, Pharmacovigilance, Marketing, and Medical colleagues across regions.
• Engage external experts/consultants to provide scientific support for business initiatives.
• Participate in Grant Reviews and Advisory Committees as needed.

Requirements

• Medical Doctor (MD) or Doctor of Osteopathy (DO) degree, or a PhD/PharmD in biological sciences.
• Minimum of 12 years of relevant experience in pharmaceutical, biotech, or life sciences industries, including supervisory responsibility.
• Prior experience in Virology, Infectious Disease, COVID-19, or Vaccines strongly preferred.
• Prior US launch experience in Medical Affairs strongly preferred.
• Experience interacting with Field Sales, MSLs, and KOLs.
• Experience strategizing and overseeing development of publications and scientific communications.
• Willingness to adapt to new therapeutic areas as needed.

Skills

• Strong interpersonal, communication, and presentation skills.
• Ability to communicate effectively with employees at all organizational levels.
• Adaptability to switch therapeutic areas as required.

Other Requirements

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

Pay

The base salary range for this full-time position is $280,000 – $350,000. Individual pay is determined by job-related skills, experience, and relevant education or training. The range does not include comprehensive benefits, bonus, long-term incentives, allowances, or additional compensation associated with the role.