Investigational Medicinal Product Manager

Job Responsibility:

About Queen's University

Queen's University is the Canadian research intensive university with a transformative student learning experience. Here the employment experience is as diverse as it is interesting. We have opportunities in multiple areas of globally recognized research, faculty administration, engineering & construction, athletics & recreation, power generation, corporate shared services, and many more.

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.

Come work with us!

Job Summary

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.

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.

REQUIRED QUALIFICATIONS:

• 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.
• Consideration may be given to an equivalent combination of education and experience.

SPECIAL SKILLS:

• 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.
• Strong communication skills, with the ability to effectively communicate with internal and external stakeholders.
• Proven problem-solving skills, with the ability to identify issues and develop effective solutions.
• Ability to work independently, as well as part of a team, with a high degree of initiative and motivation.
• Excellent organizational skills and attention to detail.
• Ability to work independently and liaise effectively in a cooperative spirit with colleagues to develop plans and implement policies and procedure.
• Ability to prioritize competing demands in a changing environment.
• Demonstrated interpersonal, listening and collaboration skills.
• Ability to manage stakeholder expectations.
• Ability to show initiative, take ownership, and work effectively on diverse and complex issues under time constraints.
• Cultural humility skills and/or experience in working with diverse audiences and perspectives.

DECISION MAKING:

• Develop standard operating procedures and work instructions and other process documents needed to support IMP activities. Ensure appropriate processes are followed and provided training as required.
• Facilitate complex process activities, leveraging all identified participants and stakeholders.
• Determine type and level of information needed to support decision-making, or when and if to escalate if needed.
• 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; monitor progress to ensure deliverables are met.
• Evaluate job candidates and make effective recommendations on suitable hires.
• Make decisions and/or effective recommendations regarding transfers and promotions.
• 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.
• Make effective recommendations on level of discipline up to discharge and probationary termination.

Employment Equity and Accessibility Statement

The University invites applications from all qualified individuals. 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. Candidates requiring accommodation during the recruitment process are asked to contact Human Resources at View email address on ca.edajobs.com.