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 135 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 Senior Manager, Clinical Trials Supply is responsible for the planning and management of
Investigational Medicinal Supplies for clinical and preclinical studies performed in the United States. Interact with and support the global development teams to assure the availability of clinical trial materials for planned clinical studies
in particular, managing supplies for Phase III studies. Interact with Shionogi Japan and Shionogi US to understand status of the manufacture, packaging, and labeling of Investigational Medicinal Product materials.
- Interfaces with Clinical Development to assess and determine required quantities of materials, develops forecast supply models to address these needs, develop clinical supply plans, packaging configurations and distribution strategies.
- Influences teams and develops / leads initiatives with strategic clinical supply insight and focus.
- Works with Clinical Trial Managers, CMC Teams, Regulatory Affairs and Quality Assurance to provide input to the design of appropriate labeling, packaging, and shipping configurations. Interfaces with relevant internal (SI) departments to communicate CMC
progress to deliver the required materials.
- Contribute to and support clinical team s selection of study-related vendors for distribution.
- Establishes drug supply chain standardization specifications across all clinical trials including the establishment of specifications for blinded clinical trials involving the use of an interactive voice response system (IVRS).
- Responsible for helping with set-up of all third party vendor specifications (i.e. IWRS) for distribution and reconciliation of clinical trial materials.
- Responsible for on-time distribution of clinical drug supply to US and worldwide clinical sites.
- Responsible for assuring accurate drug accountability/reconciliation for investigational medicinal product (IMP) issued during the study to the site and at the end of the study.
- Responsible for relationship management with key stakeholders in support of all ongoing and planned GDO and SI lead clinical trials (Phase I-IV) in US by interfacing with functions that manage Clinical Trial Materials (CTM) including manufacturing, packaging,
- Provide supply forecasts and requirements to the CMC team to ensure appropriate delivery schedules of drug product for clinical use.
- In conjunction with Drug Supply, responsible for assuring sufficient clinical drug supply is packaged, available and shipped to sites for study start up; and that sufficient supplies are maintained during the study.
- Interface with CMC functions to ensure documents and supplies meet study and regulatory requirements.
- Creating options and strategies to meet needs and/or schedules as they evolve.
- Assist Clinical Operations as needed in distribution, handling complaints, returns and destruction of drug supply.
- Work with Director of CMC Project Management to create dashboards and timelines to communicate program progress and milestones for commercial and development products.
- BA/BS in life sciences or equivalent; Advanced Degree or certification preferred.
- Minimum of 6 years experience with drug supply management to include experience managing supplies for phase III studies.
- Demonstrated expertise in oversight of CRO relationships and activities.
- Significant knowledge of pharmaceutical industry, drug development and regulatory processes in order to maintain compliance with all applicable regulatory guidelines, GXP and company SOPs and policies.
- Demonstrated ability to resolve complex problems and lead multiple projects of diverse scope, analyze data and exercise sound judgment along with the ability to recommend business alternatives to senior management.
- Strong collaborative skills with demonstrated ability to effectively work with clinical trial staff.
- Strong written and verbal communication skills along with excellent interpersonal skills and proven ability to interface effectively with diverse development teams.
Experience communicating internationally is strongly preferred.
- Work comfortably within a fast-paced and dynamic work environment and able to embrace change.
- Ability to work cross-culturally, to lead by example in establishing a close partnership and to maintain flexibility in a cross-cultural environment. Demonstrate strong working knowledge of supply chain management of clinical supplies including international
packaging regulations, import / export licensure and drug depot utilization.
- Demonstrated knowledge of labeling, packaging, inventory management and distribution procedures related to clinical supplies.
- Proficient computer skills and knowledge of standard office software.
- Ability to travel 5%-10% including possible international travel.
- Must live a commutable distance to our Corporate offices in Florham Park, NJ.
PREFERRED SKILLS AND EXPERIENCE
- Strong presentation skills and the ability to present scientific information to varied audiences.
- High sense of urgency and ability to proactively identify critical path items and develop contingency plans to mitigate risk to budget, quality, and/or timelines.
- Knowledge of GMP, GLP, GCP and GDP compliance requirements.
- Understanding of the use of an interactive voice response system (IVRS) and setting up specifications.
- Understanding of formulation / drug product process development and scale-up; packaging, technology transfer; cGMPs, ICH guidelines; as well as CMC content of regulatory submissions is also a plus.
To be considered for this position, you must apply online at: https://www.shionogi.com/careers/careers.html --
and meet the requirements of this opportunity.
We look forward to reviewing your resume & qualifications.
- We are an Equal Opportunity Employer.
- Please view Equal Employment Opportunity Posters provided by OFCCP here.