Principal Investigator (Pharmaceutical Development)

MRIGlobal is seeking a highly motivated individual to join our Integrated Pharmaceutical Solutions Business Unit as a Principal Investigator specializing in pharmaceutical development and clinical trial support. This position is on-site at our headquarters in Kansas City, MO. The successful candidate will be part of a dynamic, multidisciplinary team supporting a complex drug development and repository program. This role is intended for a seasoned drug development professional, who can operate independently, build and engage teams, drive results, lead change, and interact with business unit leadership on a regular basis. The position requires management of a wide range of disciplines including pharmaceutical and clinical trial materials management, preclinical studies including formulation development and manufacturing, drug substance and drug product manufacturing, and quality control. Thus, the individual in this role must have broad knowledge across a variety of disciplines and must be able to define, design, and implement strategic plans to enhance drug development processes and outcomes.

Principal Accountabilities and Success Factors

The Principal Investigator (PI) is responsible for leading and overseeing a complex, multidisciplinary program within the drug development spectrum. The PI provides end-to-end scientific and operational oversight of the program, supporting and overseeing studies that span pre-clinical investigation to cGMP drug substance and drug product manufacturing for early-stage clinical trials. While clinical trial execution is outside the scope of this role, the PI plays a pivotal part in ensuring timely procurement and supply of materials for clinical studies and is familiar with aspects of clinical trials including design and execution.

The position requires an understanding of FDA current Good Manufacturing Practice (cGMP) regulations and appropriate ICH guidelines, broad knowledge of the pharmaceutical development process, project leadership skills, and the ability to work collaboratively across multidisciplinary teams. Successful candidates will demonstrate scientific rigor, adaptability, and the ability to contribute to technical strategy.

Essential functions may include but are not limited to the following:

• Program Leadership and Mentorship: Lead a large multidisciplinary team and projects focused on pharmaceutical and clinical trial materials management, preclinical studies including formulation development and manufacturing, drug substance and drug product manufacturing, and quality control. Foster growth and provide guidance to junior staff and team members. Interact directly with clients to provide project updates, discuss data, and offer technical recommendations.
• Compliance and Quality: Ensure compliance with regulatory guidelines (e.g., ICH, FDA), MRIGlobal's Quality Management System, and client quality requirements.
• Collaboration and Communication: Work closely with cross-functional teams, including synthesis and API manufacturing, drug product formulation and manufacturing, analytical chemistry, quality assurance, and project management to ensure alignment in drug development efforts. Work closely with governmental agencies, universities and other collaborators that are part of a broad network conducting and carrying out early phase clinical trials. Provide regular updates to senior management and stakeholders on the progress of drug development programs, challenges, and strategic recommendations.
• Manufacturing and CMC: Oversee the procurement, labeling, packaging, distribution, and stock recovery of clinical trial materials. Collaborate with the analytical team to develop, validate, and implement methods for quality control of raw materials, intermediates, bulk, and finished products. Oversee the development and scale-up of drug substance and drug product manufacturing processes. This work is done with both internal resources as well as external partners and subcontractors.
• Strategic Planning: Define, design, and implement strategic plans to enhance drug development processes and outcomes.
• Research and Innovation: Stay up to date with the latest scientific advancements and technologies in the pharmaceutical development field and incorporate them, as applicable, to enhance the company's drug development capabilities. Strive to present work at conferences and publish research findings and patents where applicable.

Supervisory/Management Responsibilities

1. Leads a 10+ person project team across multiple facilities and labs in Kansas City, MO and North Kansas City, MO. Must be able to work in a cross-functional environment where project team members have different line management and may be working on more than one project and for other Principal Investigators depending on workload.

2. Must be able to work with, and oversee, outsourced activities including working with subcontractors and vendors who may perform specific activities such as manufacturing, logistics support, and outsourced analytical testing.

Minimum Qualifications

• PhD or MS in Pharmaceutical Sciences, Chemistry, Pharmacy, or a related technical field.
• A minimum of 7 years (PhD) or 10 years (MS) of relevant experience overseeing multidisciplinary drug development programs.
• Working knowledge of cGMP regulations and ICH guidelines.
• General knowledge in drug substance and drug product manufacturing, analytical chemistry, and clinical trial materials management.
• Strong leadership, organizational, and project management skills.
• Excellent oral and written communication skills and the ability to engage with staff at all levels across organizational lines.
• Effective in a fast-paced environment.
• Proficient in the use of Microsoft Word, Excel, PowerPoint, Outlook, and Teams and the ability to learn new software and systems.
• Ability to travel as needed (5%).

Preferred Qualifications

• Knowledge of international pharmaceutical regulations (e.g., Health Canada, EMA, etc.).
• Experience managing or performing US government contract work.
• Project Management Professional (PMP) Certification.
• Strong publication record in the field of drug development.
• Familiar with FDA GLP regulations.