Shionogi Inc. is the U.S. subsidiary of Shionogi & Co., Ltd., a leading Japanese pharmaceutical company with state of the art research capabilities that has provided innovative medicines essential to people's health for over 140 years.
In the US, Shionogi Inc. develops and commercializes pharmaceutical products that address unmet medical needs in the areas such as pain and anti-infectives.
The Director, CRO / Vendor Management will proactively provide leadership and a new vision concerning the overall picture of outsourcing strategy for Shionogi Global Clinical Development. Will provide inspiration and innovation by tapping into industrial networking and information sources.
Will be responsible for leading discussions with financial, legal, QA and other SI departments leading to development of a "best approach" and "best practices" -- while maintaining conformance with all relevant laws, regulations, guidelines, policies and procedures.
In addition, will be responsible for clinical outsourcing including: CRO/vendor management, vendor selection & oversight, sourcing process for clinical operations including Request for Proposal (RFP) development and execution, contract negotiations, contract management, setting of standards, cost savings development/tracking and budget management in support of the clinical development programs.
Lead development and share responsibility for the timeline, budget and resource planning functions and development plans in Shionogi Clinical Development.
Will lead and manage SI CBO function while closely communicating with the counterparts in SHQ and SBV.
Will manage direct reports.
Responsible for gatekeeping legal, financial and other functional requests.
Lead relationship development and maintenance with CROs and other vendors.
Participate in drafting operational components of clinical development plans and scenarios, including budgets and resource estimates. The individual must be able to plan and manage multiple development programs, including timelines, costs and key deliverables.
Ensure clinical programs are executed within projected budget, and promptly communicate any change in scope of budget.
Ensure process consistency and knowledge sharing within department.
Effectively plan, implement, monitor, and report on the status of programs.
Oversee financial documentation supporting contract milestones, Sarbanes-Oxley compliance, accruals and invoice reconciliation.
Contribute to project budget/resource planning, re-forecasting, milestone, payment and variance tracking along with CPMs, Finance and Project Management.
Develop, track, analyze, and report on CRO key performance metrics.
Maintain clinical trial budgets and efficiency through up-to-date resource benchmarks.
BA/BS Degree in related field.
Minimum of 10 years of experience to include sourcing, vendor negotiations, and operations management; including at least 5 years with significant experience in project management effectively leading projects from inception to completion, coupled with demonstrated ability to hold team members accountable to tight timelines and budgets.
Pharmaceutical Industry experience; clinical operations experience is preferred.
Expertise in vendor management, vendor strategic partnering, contract negotiation, procurement strategy and execution, and budget management.
International trial execution experience is a plus.
Supervisory experience with strong leadership skills and ability to work within cross-functional teams.
Excellent interpersonal, organizational, and communications skills; and multi-tasking skills.
Must be willing and able to travel up to 20% - domestic and international with ability to travel via automobile and/or airplane.
Ability to articulate clearly and conduct verbal presentations with large and small audiences.
Ability to sit for extended periods of time up to four (4) hours at a time.
Must live a commutable distance to our New Jersey offices.
To be considered for this position, you must apply and meet the requirements of this opportunity.
We look forward to reviewing your resume & qualifications.
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 responsibilities may 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.