Vice President, Clinical Virologist, Clinical Development - Pharma

The Vice President, Clinical Virology is responsible for leading the organization's strategic research and development initiatives in virology by orchestrating pivotal strategic clinical investigations, meticulous supervision of clinical trials, curation and presentation of scholarly publications, and by having judicious engagement with regulatory authorities through written correspondence, in-person dialogues, and advisory committee interactions.
The Vice President, Clinical Virology serves to advance the organization's position as a leader in clinical virology through innovative research, publication excellence, and adherence to regulatory, legal and ethical requirements.
RESPONSIBILITIES
The following job duties are not all-inclusive and additional responsibilities may be added to the role as needed. The duties and responsibilities listed are intended to provide a general overview of the position and may change over time based on the needs of the organization.

• Establishes research goals and priorities that advance the organization's position dealing with viral diseases based on organizational objectives.
• Leads cutting-edge research and clinical trials in virology, fostering innovation and development of diagnostics, therapies, and solutions for viral diseases.
• Designs and implements clinical trials within virology in accordance with regulatory guidelines.
• Oversees the execution of clinical trials, ensuring adherence to protocols and quality standards.
• Analyzes trial data and provides guidance for course corrections as needed.
• Oversees quality control measures to maintain the accuracy and reliability of research data and results.
• Implements quality improvement initiatives to enhance the credibility of the research.
• Collaborates with cross-functional and regional teams to prioritize and execute investigative projects.
• Establishes and executes strategic publication plans, positioning the organization as a recognized contributor in the field of virology to ensure Shionogi's research findings are widely recognized.
• Collaborates with research and medical affairs teams to prepare scientific publications, abstracts, and presentations.
• Disseminates research findings through presentations at conferences and publications in peer-reviewed journals.
• Maintains an updated knowledge of developments in the virology field and represents the company in scientific forums.
• Ensures strict adherence to all regulatory standards and guidelines in clinical virology research.
• Oversees audits and inspections to maintain the highest level of compliance.
• Establishes and maintains positive and active relationships with regulatory authorities.
• Prepares and submits regulatory responses, documents and applications as necessary.
• Participates in face-to-face meetings and advisory committees to address regulatory matters.
• Works as an individual contributor with decision making authority over clinical research virology related activities and programs - while establishing and maintaining collaborations with internal departments, academic institutions, and industry partners.
• Identifies opportunities for joint research projects, funding, and knowledge exchange.
• Efficiently allocates resources to research initiatives, publications, and regulatory compliance efforts.
• Monitors and manages departmental budgets to ensure effective use of resources.
• Stays updated with the latest advancements in virology research and related fields.
• Identifies opportunities for research innovation and expansion to contribute to the organization's scientific impact.

REQUIREMENTS

• M.D. and / or Ph.D., or equivalent advanced degree in virology, microbiology, immunology, or a closely related field. Board certified virologist a plus.
• Minimum of 14 years of relevant experience in clinical virology, preferably within the pharmaceutical or biotechnology industry.
• Significant experience in leading virology-related projects, including clinical trials and research initiatives.
• Profound knowledge of virology, including viral pathogenesis, diagnostic methods, and treatment strategies along with a commitment to staying updated with the latest advancements in clinical virology and applying new knowledge to strategies.
• Ability to design and oversee clinical trials, including knowledge of trial endpoints and virology-related protocols.
• Strong analytical skills for interpreting virology data and making informed decisions.
• Leadership and management experience, especially in guiding cross-functional and/or regional strategic initiatives.
• Proficiency in scientific writing and communication for publishing research articles and manuscripts.
• Strong track record of contributions to scientific publications.
• Strategic planning for disseminating research findings through publications.
• Ability to conduct peer reviews of scientific publications.
• A solid understanding of regulatory guidelines and processes specific to clinical virology.
• Collaboration with various stakeholders including regulatory agencies and internal partners such as regulatory affairs teams to align virology activities with regulatory requirements.
• Effective communication with regulatory authorities and ability to respond to inquiries.
• Ability to travel approximately 25% of the time both domestically and internationally, as necessary.

PREFERRED SKILLS AND EXPERIENCE

• Understanding of GLOBAL regulatory guidelines related to virology research and clinical trials.
• Skill in managing relationships with external virology service providers.
• Strong knowledge of intellectual property principles and experience in safeguarding research innovations.
• Ability to design and implement a comprehensive quality management system that encompasses all aspects of clinical virology research trials, ensuring adherence to regulatory standards, data integrity, and continuous improvement is a plus.
• Experience in preparing and submitting regulatory documents, such as INDs, NDAs, or BLAs is a plus.
• Track record of successful interactions with regulatory authorities, such as the FDA (U.S. Food and Drug Administration) or equivalent agencies in other regions is a plus.

ESSENTIAL PHYSICAL 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 < 18" away from face for extended period of time - up to four (4) hours at a time.
• 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.

Hybrid work arrangements will allow work from home combined with your presence on-site 2-3 days/week (when not traveling) at our US HQ in Florham Park, NJ.
To be considered for this position, you must apply and meet the requirements of this opportunity.
We look forward to reviewing your resume & qualifications.
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 responsibilitiesmay change or be assigned at any time with or without notice.
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.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)