Overview

The Medical Director, Medical Affairs (COVID-19/Virology) - Evidence Generation 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 with focus on evidence generation and represent Medical Affairs at various cross-functional team meetings.

This Medical Director will have 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

• Assist the Sr. Medical Director in the development of the US Medical strategy and tactical planning for virology/COVID-19 platform including the 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 Sr. Medical Director, 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
• Design and lead study protocols (RWE, epi, SLR, other types) and evidence generation to support the TA/Product Strategy
• Participate in the Grant Reviews and Advisory Committees as needed / requested

Minimum Job Requirements

Qualifications

• Medical Doctor or a Doctorate of Osteopathy degrees or PhD/PharmD level in biologic sciences
• 8-10 plus years relevant experience in a pharmaceutical company
• Prior experience in Virology. Experience in COVID-19, and/or Vaccines is strongly preferred
• Prior US launch experience in Medical Affairs preferred
• Experience in the design and lead RWE studies using a variety of data sources, including administrative claims, EHR, and surveys to demonstrate the value of assigned products to key stakeholders
• 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

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.

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.