Product Manager International F/H

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We are committed to employment equity and diversity in the workplace and welcome applications from individuals from equity seeking groups such as women, racialized/visible minorities, Indigenous/Aboriginal peoples, persons with a disability, persons who identify in the LGBTQ+ community and others who reflect the diversity of Canadian society.

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. 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. Escalates issues and identifies solutions to concerns identified to relevant portfolio Manager (Phase III / IND), Senior Investigator/Faculty, and Senior Leadership as required. This includes development, review, and maintenance of this material and accountability for ensuring that CCTG remains in compliance with all applicable regulations and guidelines. Serves as the primary point of contact for CCTG with vendors involved in the drug supply process (e.g. 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. 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.

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. 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. Identifies risk in activities that fall outside of defined scope, escalates appropriately, and assists in correction.

Represents CCTG at Group/national level meetings and presents/provides education on IMP related matters.

Bachelors Degree in Pharmaceutical Sciences or a Masters Degree in Biological Science, Health Science, or related field.

Additional training or credentialing in pharmacotherapy (eg. Board Certified Oncology Pharmacists (BCOPs), CAPhO, and/or COSA) considered an asset.

At least 5 years of experience in academic research or pharmaceutical or biotech industry, with experience in managing investigational medical products in clinical trials.

Demonstrated proficiency with programs such as Microsoft Word, Excel, PowerPoint and MS Project as well as communication tools such as MS Teams and Zoom and project management tools.

Excellent project management skills, with the ability to manage multiple projects simultaneously and prioritize competing demands.

Strong knowledge of GMP regulations, Health Canada Food and Drug Regulations, FDA guidelines, and international regulatory requirements with particular focus on EMA.

Ability to work independently and liaise effectively in a cooperative spirit with colleagues to develop plans and implement policies and procedure.

Ensure appropriate processes are followed and provided training as required.

Provide recommendations on best alternatives to a given problem, identifying potential risks and benefits of each.

Oversee staff and allocate appropriate resources to studies and projects; Evaluate employee performance and decide on appropriate training or coaching to address lack of proficiency in carrying out responsibilities, or remedial action for staff disciplinary situations.

Employment Equity and Accessibility Statement

Queen's is committed to employment equity and diversity in the workplace and welcomes applications from women, visible minorities, Aboriginal Peoples, persons with disabilities, and persons of any sexual orientation or gender identity. In accordance with Canadian Immigration requirements, priority will be given to Canadian citizens and permanent residents.

The University provides support in its recruitment processes to applicants with disabilities, including accommodation that takes into account an applicant's accessibility needs.