Shionogi Inc. (U.S.)

Associate Director, Government Operations

Shionogi Inc. (U.S.)

full-time

Posted on:

Location Type: Hybrid

Location: Florham Park • New Jersey • United States

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Salary

💰 $180,000 - $210,000 per year

Job Level

Senior

About the role

  • 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

  • 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
  • Health insurance
  • Retirement plans
  • Paid time off
  • Flexible work arrangements
  • Professional development opportunities
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

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