Associate Director, Government Operations

Shionogi Inc.•Florham Park, NJ

3d•Hybrid

About The Position

The Associate Director, Government Operations will report to the Senior Director, Government Operations and will be responsible for technical and program management activities related to Shionogi’s US Government contracts, including partnerships with agencies such as BARDA, NIH, and the Department of Defense (DOD). This role serves as the primary liaison with internal teams and government agencies in an alliance management capacity, ensuring alignment on program deliverables, budgets, and compliance reporting. Utilizing a robust understanding of and experience with pharmaceutical development and manufacturing, the Associate Director leads efforts of cross functional teams to successfully execute complex, multi-year agreements and foster strong business relationships. This role requires demonstrated experience and technical acumen leading government-funded pharmaceutical programs, strong operational and coordination skills, and a commitment to delivering excellence in program execution.

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.
Able to establish and independently manage close working relationships with US Government partners and across the global Shionogi organization.
Comfortable and capable in a variety of cultures and skilled in working across multiple functions and time zones.
Team oriented with the confidence and integrity to work effectively as a member of an innovative and nimble global organization.
Able to effectively work with a highly performing functional team.
Able to establish rapport, value and respect within a complex and highly technical environment.
Able to sell ideas and influence directly and indirectly.
Strong attention to detail and tracking of deadlines.
Able to understand financial reporting, collaborate with finance/accounting departments to obtain information and interpret data for inclusion in financial reporting deliverables.
This position has managerial and decision-making authority.
Ability and willingness to travel approximately 10% of the year both domestically and internationally
Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ or our Qpex Biopharma office in San Diego, California. Office presence required at least 50% of the time per month.

Responsibilities

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.
Other duties as assigned.