Job Description

Overview

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 Shionogis 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.

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.

Minimum Job Requirements

Qualifications

• Bachelors 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.

Competencies

• 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.

Other Requirements

• 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.

Additional Information

The base salary range for this full-time position is $180000 - $210000. Individual pay is determined by several factors which include but are not limited to: job-related skills experience and relevant education or training. The range does not include the comprehensive benefits bonus long-term incentive applicable allowances or any additional compensation that may be associated with this role.

EEO

Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race color religion sex (including pregnancy) 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 for protected veterans and individuals with disabilities in compliance with all federal state and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are in fact non-discriminatory.

If you are qualified individual with a disability or a disabled veteran you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling or by sending an email to

Required Experience:

Director

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