Senior Manager, Clinical Trial Supply, Reg. Affairs – Shionogi Inc – Florham Park, NJ, USA

Shionogi Inc. is the U.S. subsidiary of Shionogi & Co., Ltd., a leading Japanese pharmaceutical company. We are in a unique position of having the financial backing and the research capabilities of a well-established leading Japanese pharmaceutical company, matched with the entrepreneurial spirit of a start-up company.

Shionogi Inc. develops and commercializes pharmaceutical products that address unmet medical needs in the areas such as pain, women’s health and anti-infectives. Together with our Japanese corporate parent, Shionogi has been providing innovative medicines essential to people’s health for over 130 years.

We are seeking dynamic, focused and creative individuals to join our growing team. We are currently expanding our workforce in our New Jersey headquarters location and looking for experienced pharmaceutical professionals to help us build for the future.

The Senior Manager, Clinical Trial Supply is responsible for the planning and management of drug supplies for clinical and preclinical studies performed in the United States. Will interact with and support the global development teams to assure the availability of clinical trial materials for planned clinical studies. Will also interact with Shionogi Japan and Shionogi US to understand status of the manufacture, packaging, and labeling of Investigational Medicinal Product materials.

DUTIES AND RESPONSIBILITIES 

• 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, Pharmaceutical Development, 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.
• 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), and the integration of electronic data capture (EDC).
• 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, and labeling.
• Provide supply forecasts and requirements to the CMC team to ensure appropriate delivery schedules of drug product for clinical use.
• Interface with CMC functions to ensure documents and supplies meet study and regulatory requirements.
• 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.

MINIMUM JOB REQUIREMENTS 

• BA/BS in life sciences or equivalent; Advanced Degree or certification preferred.
• Minimum of 5 years’ experience with drug supply management.
• Demonstrated expertise in oversight of CRO relationships and activities.
• Experience with warehouse setup and inventory distribution systems and associated SOPs and documentation. Expertise with cold chain distribution is required.
• Knowledge of comparator sourcing and blinding methods for intravenous drugs.
• Experience working at a CRO/CMO for clinical trial materials.
• 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.
• 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 10%-15% including possible international travel.
• Must live a commutable distance to our US Corporate Headquarters 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.
• Understandings 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

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