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 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.
Minimum Job Requirements
Qualifications
Medical Doctor or a Doctorate of Osteopathy degrees or PhD/PharmD level in biologic sciences.
7 plus years relevant experience in a pharmaceutical company to include Supervisory responsibility for direct reports.
Prior experience in Virology. Experience in COVID-19, and/or Vaccines is strongly preferred.
Prior US launch experience in Medical Affairs 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.

Essential Physical and Mental Requirements
Ability to articulate clearly and conduct verbal presentations with large and small audiences.
Ability to travel via automobile and/or airplane.
Ability to view video display terminal images
Ability to operate a computer keyboard and telephone.
Ability to sit for extended periods of time - up to four (4) hours at a time.
Ability to lift, tug, pull up to fifteen (15) pounds.

DisclaimerThe 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,...

Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity