The Microbiologist is responsible for leading diagnostic planning/development and driving the overall diagnostic strategy to address current and evolving testing issues for Shionogi US.
In addition, this role will support the development and ensure accuracy of external communications, education and medical resources related to diagnostics and microbiology. The Microbiologist will also be responsible for providing critical microbiology support for publications, surveillance studies, lifecycle strategy, data generation and clinical development/regulatory activities.
Work collaboratively with the Global Medical, Business and Biomarker divisions on all interactions between diagnostic manufacturers and Shionogi:
Establish strong working relationships with diagnostic manufacturers.
Serve as a subject matter expert for diagnostics manufacturers and ensure that development issues are addressed in a timely manner.
Evaluate and make recommendations for investment in newer antimicrobial susceptibility technologies and/or develop strategy to optimize current technologies.
Drive and execute overall strategy to address current testing issues in the US market:
Develop strategy and tactics to ensure all US labs are appropriately testing with approved technologies.
Lead efforts to engage with and provide support to large national/regional and reference labs.
Assist labs in troubleshooting issues when they arise (i.e. during the verifications process, etc.).
Oversee the microbiology programs that support the US market (i.e. resistant isolate retesting program, local surveillance studies, etc.).
Subject matter expert for the development of external materials and internal training for both commercial and medical teams.
Identify and liaise with KOLs on topics related to diagnostics and microbiology:
Support field teams with microbiology/diagnostic related issues that arise with KOLs upon request.
Provide microbiology support for publications, surveillance studies, lifecycle strategy, data generation and clinical development/regulatory activities:
Support development of publication strategy and publications with a focus on microbiology data.
Support product differentiation related to current and emerging resistance development with key competitors.
Identify strategic opportunities for data generation.
Lead development and execution of microbiology studies as identified for the US market .
Support long-term lifecycle strategy for current marketed anti-infectives including, but not limited to clinical studies, real world evidence studies, surveillance studies, etc.
Support the development of any new Shionogi anti-infectives.
Provide expert input and review for any regulatory documents/communications as requested for appropriate sections.
Travel is anticipated to be up to 30%.
M.D. in Microbiology.
Minimum of 5 years post-doctoral experience related to microbiology and microbial pathogenesis.
Demonstrated deep understanding of microbiological theories, concepts and principles.
Experience working in the pharmaceutical industry is strongly preferred.
Prior work or experience in the medical device (i.e. microbiology diagnostic) industry also preferred.
Familiar with microbiology laboratory test methods, regulatory standards, and practice guidelines.
Deep understanding of all diagnostic methods used (both phenotypic and genotypic) to diagnose and evaluate Gram-negative infections.
Ability to establish, manage and lead external partnerships with key diagnostic partners and collaborators.
Demonstrated ability to lead cross-functional multidisciplinary teams.
Proficient in writing research protocols and scientific papers.
Excellent interpersonal, analytical, communication (oral and written), presentation, and project management skills.
Ability to work in a highly matrixed global environment as an individual contributor.
Ability to travel via automobile, train and/or airplane.
Hybrid work arrangements will allow work from home combined with your presence on-site 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.
Please be aware that Shionogi Inc. mandates COVID-19 vaccination of all employees and contractors regardless of work location. Accommodations may be made in accordance with applicable law.
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.
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...
Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity