The Investigational Medicinal Product Lead is responsible for leadership of CCTG operations related to investigational medicinal product (IMP) policies and processes, procurement, distribution, and oversight essential to the conduct of national and international multi-centre clinical trials of cancer therapy in compliance with applicable guidelines, regulations, and standards.

Reporting to the Manager Office of Clinical Trial Management (Phase III/Late Phase) and working in collaboration with the Manager Early Drug Development Program (IND), the incumbent is responsible for ensuring IMP plans established are compliant and meet the needs of the study protocol and regulatory requirements. Further, the incumbent will partner with trial teams, information technology teams, as well as the Quality and Innovation leads, to ensure IMP is managed in an efficient and effective manner. This includes establishing partnerships and relationships with IMP vendors nationally and internationally and managing complex product requirements and supply challenges. The IMP Lead is accountable for overall leadership and execution of drug supply operations, ensuring the CCTG is current with applicable regulations and guidelines and best practices, collaboration with vendors and stakeholders.

Job Description
KEY RESPONSIBILITIES:
• Manage the development of IMP supply plans and processes including development of the plan, partnership with vendors, and oversight activities (quality assurance/quality control) to ensure plans in place adhere to Good Manufacturing Practices (GMP).
• Manage drug supply operations for the CCTG, serving as liaison and resource for the OSC team, the Pharmacist Network Steering Committee, and network stakeholders. Strategically monitors drug supply and supply chain concerns to ensure the needs of CCTG clinical trials are addressed. Escalates issues and identifies solutions to concerns identified to relevant portfolio Manager (Phase III / IND), Senior Investigator/Faculty, and Senior Leadership as required. Responsible for identifying solutions to IMP scenarios such as shortages.
• Responsible for all IMP Standard Operating Procedures, Work Instructions, and generic Trial documentation for the CCTG. This includes development, review, and maintenance of this material and accountability for ensuring that CCTG remains in compliance with all applicable regulations and guidelines. Responsible for ensuring CCTG is update to date/current with the regulations, guidelines, and practices related to IMP. Initiates continuous evaluation of group IMP processes and responsible for driving process change through consultation with relevant stakeholders.
• Serves as the primary point of contact for CCTG with vendors involved in the drug supply process (e.g. Bay Area Research Logistics (BARL). Establishes and manages oversight framework for vendors involved in CCTG drug supply and ensures appropriate accountability of concerns and identifies potential solutions for CCTG consideration. Develops vendor Request For Services Plans for IMP services in partnership with the Manager Finance.
• Provide direction and compliant/effective solutions for trial teams during study start up (contract and protocol development) and well as throughout the life of a clinical trial as IMP practices change during the course of a study. Guidance and support includes, but is not limited to, procurement of investigational agent and blinded drug supply, packaging, labeling and re-labeling, frequency of supply, expiry date issues, recall, retention of samples, destruction of supplies as well as other drug accountability requirements.
• Leads and creates drug forecasting strategy for the clinical trial.
• Oversees IMP supply at centres and vendors to ensure effective expiry date is in place and to ensure drug is review, quality assurance steps are completed, and drug is destroyed in a timely manner due to financial implications.
• Responsible for management of blinded trial drug requirements in partnership with information technology and compliance teams. This individual operating outside of the trial team would have an unblinded project management role to support supply and warehouse management.
• Develop educational materials and conduct training on aspects of IMP relevant to CTG activities. Develop generic documentation such as generic pharmacy manuals that can be adopted for study-specific use.
• Establish and execute a quality assurance/quality control framework for IMP processes at CCTG.
• Key liaison to the Pharmacist Network Steering Committee and Pharmacist Network in partnership with Trial Management Associate. Provides support to these groups, including regular meetings and organizing agendas, minutes, and the content of routine and Spring Meeting sessions. Recruits, onboards and trains new members, and supports their ongoing engagement.
• Identifies risk in activities that fall outside of defined scope, escalates appropriately, and assists in correction.
• Demonstrates commitment to fostering a diverse, equitable and inclusive environment, and contributes to an environment that is respectful and collaborative.
• Represents CCTG at Group/national level meetings and presents/provides education on IMP related matters.
• Undertake other duties as required in support of IMP as required.