Senior Manager, Clinical Supplies

Overview

Entrepreneurial Spirit, Rooted in Tradition. Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U. S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which touts a storied reputation more than 300 years in the making. Our parent company - one of Japan's most respected - is a research-driven pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several first-in-class medicines for serious diseases, including multiple sclerosis (MS), diabetes mellitus (DM), and amyotrophic lateral sclerosis (ALS) and Parkinson's (PD).

MTPA is rapidly expanding its operations across all functional areas. MTPA's commitment to patients and their communities continues with a robust late-stage pipeline of investigational treatments for difficult-to-treat diseases and commercializing products with significant unmet medical needs in North American markets. In the United States, MTPA launched rare diseases treatments including RADICAVA® (edaravone) injectables in 2017, EXSERVAN™ (riluzole) oral film in 2021, and RADICAVA® (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, and business development functions. MTPA is dedicated to improving the treatment environment for those with debilitating diseases, researching on real-world evidence, and creating hope for all facing illness.

The Senior Manager, Clinical Supplies will manage the complete clinical supply chain of Investigational Medicinal Products (IMPs) from bulk manufacture to finished IMP through to destruction of clinical supply materials, ensuring compliance with agreed requirements of all allocated clinical studies with regards to time, cost and quality standards.

The incumbent is accountable for effectively managing the clinical supply chain in accordance with study protocols, cGMP, EU GMP, GCP, ICH, FDA and any applicable international, federal and/or local laws and regulations and Standard Operating Procedures.

Responsibilities

• Plans, schedules, and coordinates the importation, production, release, distribution, and destruction of IMPs for all assigned PI - PIV, single center and/or multicenter global clinical studies.
• Negotiates IMP requirements for clinical studies with Mitsubishi Tanabe Pharma Corporation (MTPC).
• Recommends study specific IMP packaging and label designs, and production schedules to MTPC and Clinical Operation Teams (COT).
• Participates in COT meetings as the Clinical Supply representative.
• Coordinates Clinical Supply activities across functions within MTPA, MTPC and MTPE (Mitsubishi Tanabe Pharma Europe Ltd), including, but not limited to, Clinical Operations, Chemistry, Manufacturing and Controls (CMC), Product Quality Assurance (PQA), Regulatory Affairs and Sourcing departments.
• Identifies suitable contract packaging organizations (CPO) for each study, and manages the capability and feasibility assessments of any new service providers.
  
  • Assists PQA with audits of any current or potential new CPOs.
• Collaborates with Regulatory Affairs to provide all documents required for IND, CT or other Regulatory submissions.
• Generates Clinical Supply Specification and Work Order/Change Order documents.
• Works with PQA and Legal to ensure that all agreements, including Confidential Disclosure Agreements (CDA), Master Services Agreements (MSA), and Quality Agreements (QA) are current for all approved CPOs.
• Manages supply stock inventories for resupply forecasting and batch traceability.
• Oversees CPOs to ensure compliance with GMP, GCP, applicable Clinical Trial Regulations and agreed Work Orders and Clinical Supply Specifications documents.
  
  • Meets with CPOs regularly to review performance.
• Manages Interactive Response Technology (IRT) requirements for Clinical Supply activities, including set up, user acceptance testing and on-going management.
• Reviews and approves Investigator site storage & dispensing activities.
• Manages activities related to IMP shelf-life extensions.
• Creates and maintains study specific Clinical Supply trial master files.
• Ensures budget control and correct processing of invoices
• Tracks and reports current Clinical Supply activities by contract manufacturer and study as requested.
• Creates/participates in developing, implementing, and harmonizing clinical supplies related Standard Operating Procedures and Policies.

Qualifications

• Minimum BS/BA degree in life/health sciences or related field
• Minimum of 5 years of industry experience, including a minimum of 3 years of experience in labeling, packaging and distribution of clinical trial materials.
• Experience in managing diverse project activities with manufacturing and packaging facilities at different geographical locations.
• Experience working in a multi-cultural environment
• Excellent project management, problem solving and attention to detail skills essential.
• Must be able to communicate and present effectively in both oral and written form.
• Knowledge of FDA, ICH, cGMP and EU GMP, GCP, and other regulatory regulations and guidelines.
• Demonstrated knowledge of current pharmaceutical processes, packaging operations and drug development processes.
• Knowledge of clinical supply aspects of IND/CT requirements.
• Experience with IRT specification set up and management an advantage.
• Demonstrated ability to contribute successfully in a multi-disciplinary team environment / matrix organization.
• Competency in Windows, MS Office, Word, Excel, PowerPoint and other related computer software (e. g. , MS Project)

Our Value Proposition:

Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits.

MTP provides a competitive benefits package inclusive of Medical and Dental health benefits, short-term and long-term disability plans, Company Paid and Supplemental Life insurance and additional voluntary benefits such as Critical Illness Insurance, Accident Insurance, Legal Plan, and ID Theft Protection. In addition, we provide a generous PTO policy based on tenure, commencing with 24 PTO days, pro-rated based on hire date.

The salary range for this position is $135,000 - $160,000. Factors such as scope and responsibilities of the position, candidate's work experience, education/training, job-related skills, internal peer equity, as well as market and business considerations may influence base pay offered. This salary may be subject to a geographic adjustment (according to a specific city and state and depending on the role), if an authorization is granted to work outside of the location listed in this posting.

This position is eligible to participate in our annual Short-Term Incentive (STI) program. Specific information about the plan including eligibility rules and target, will be.