Associate Director, Government Operations

Shionogi Inc. (U.S.)

Associate Director overseeing government operations and partnerships at Shionogi. Leading cross-functional teams in pharmaceutical development and ensuring compliance with government contracts.

Posted 4/10/2026full-timeFlorham Park • New Jersey • 🇺🇸 United StatesSenior💰 $180,000 - $210,000 per yearWebsite

About the role

Key responsibilities & impact

Responsible for program and technical management of Shionogi products being developed in collaboration with U.S. Government agencies, ensuring alignment with program goals and timelines.
Ensures full compliance with federal regulations and funding guidelines while effectively managing resources to advance the development of assets governed by U.S. government agreements.
Serves as the primary liaison with U.S. government personnel, cultivating collaborative relationships to drive program technical execution and success.
Monitors and compiles report on status to internal stakeholders, proactively identifying potential issues and proposing mitigation strategies to address potential risks.
Leads program meetings and teleconferences with government agencies ensuring adherence to all reporting requirements and fostering clear communication.
Manages development and review of program materials including presentations, meeting minutes, monthly reporting metrics, and cost allocations, ensuring accuracy and completeness.
Supports initiatives to identify and evaluate new collaboration opportunities with U.S. Government agencies, coordination of White Papers, Technical Proposals, and Cost Proposals to secure future partnerships.
Identifies and proactively manages risks associated with government contracts, including financial, regulatory, and operational risks.
Monitors and tracks submission requirements to ensure timely compliance.
Facilitates alignment and collaboration between internal teams (e.g., R&D, Finance, Regulatory Affairs, Legal) and external stakeholders to ensure seamless program execution.
Contributes to the negotiation, execution, and amendments of contracts with government agencies.
Represents Shionogi at industry forums, conferences, or government meetings to advocate for program needs and establish thought leadership.

Requirements

What you’ll need

Bachelor’s degree in life sciences, business administration, or related field required; advanced degree such as PhD or MS preferred
At least 8 years of directly relevant experience in R&D, program management, government operations, or contract management within the pharmaceutical/biotech industries.
Proven expertise serving as technical lead for complex U.S. Government contracts, including experience with BARDA, NIH, and/or DOD.
Demonstrated technical expertise in nonclinical studies, clinical trials, and manufacturing processes for medical countermeasure development, with a strong preference for expertise in antibiotic development and manufacturing.
Successful experience navigating federal regulations, managing compliance reporting, and addressing audit requirements specific to government-funded pharmaceutical programs.
Strong financial management skills, including budgeting, cost allocation, and financial reconciliation for federally funded programs.
Experience working in cross-functional teams in a highly regulated environment.
Strategic thinking and decision-making skills.
Strong written and verbal communication skills, with the ability to effectively engage with senior government officials and internal stakeholders.
Strong presentation skills, with the ability to distill complex technical or regulatory information into clear, compelling narratives tailored to diverse audiences, including government officials, cross-functional teams, and executive leadership.

Benefits

Comp & perks

Health insurance
Retirement plans
Paid time off
Flexible work arrangements
Professional development opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

program managementtechnical managementcompliance reportingfinancial managementbudgetingcost allocationnonclinical studiesclinical trialsmanufacturing processesantibiotic development

Soft Skills

strategic thinkingdecision-makingwritten communicationverbal communicationpresentation skillscollaborationrelationship buildingrisk managementproblem-solvingstakeholder engagement

Certifications

Bachelor’s degreePhDMS