Investigational Medicinal Product Manager

8 months ago

Kingston, Canada Queen's University Full time

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.
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.
**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 li

  • Investigational Medicinal Product Manager

    8 months ago

    Kingston, Canada Queen's University Full time

    Investigational Medicinal Product Manager 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,...

  • Sr. Product Development Engineer

    7 months ago

    Kingston, Canada Lonza Full time

    Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...

  • Diagnostic Imaging Specialist

    4 weeks ago

    Kingston, Ontario, Canada Kingston Health Sciences Centre Full time

    As a Diagnostic Imaging Specialist in our Nuclear Medicine department, you will play a vital role in delivering high-quality patient care. Located at Kingston Health Sciences Centre, our team is dedicated to providing exceptional service and expertise in diagnostic imaging.Job SummaryWe are seeking an experienced Diagnostic Imaging Specialist with a strong...

  • Senior Product Development Specialist

    4 weeks ago

    Kingston, Ontario, Canada Lonza Full time

    At Lonza, we're committed to creating innovative solutions that improve lives. Our team is seeking a skilled Mechanical Engineer to join our Kingston, ON location and contribute to the development of cutting-edge cell therapy manufacturing platforms.About the Role:As a key member of our Product Development team, you'll drive continuous improvements in the...

  • Production Supervisor

    7 months ago

    Kingston, Canada Canada Royal Milk Full time

    **About the Company** Canada Royal Milk, located in Kingston, Ontario, is a member of the Feihe International group of companies, Asia’s number one infant formula brand. Canada Royal Milk is the only producer of infant formula in Canada, manufacturing quality products from Canadian cow and goat milk, ensuring the highest quality and nutritional value for...

  • Experienced Undercover Loss Prevention Investigator

    4 months ago

    Kingston, Canada Loss Prevention Services Limited Full time

    **Loss Prevention Services Limited** (LPS) is Ontario’s leading provider of security personnel, dedicated to safeguarding a diverse range of clients across the region. We are committed to excellence in security and loss prevention, and we are currently seeking a highly skilled and experienced Undercover Loss Prevention Investigator to join our team in the...

  • Veterinary Medicine Specialist

    4 weeks ago

    Kingston, Ontario, Canada VetCare Canada Inc. Full time

    We are a dynamic after-hours emergency hospital located in Kingston, Ontario, Canada. Our fast-paced environment deals with emergencies in small animals, and our ideal team member would be eager to learn, adept at multitasking, and possess exceptional client communication skills.About The Role:Our sought-after Veterinarian (DVM) will have 2-5 years of...

  • Mechanical Engineer

    4 weeks ago

    Kingston, Canada Lonza Full time

    Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...

  • Production Manager

    7 months ago

    Kingston, Canada Canada Royal Milk Full time

    **About the Company** Canada Royal Milk is a member of the Feihe International group of companies, Asia’s number one infant formula brand. Canada Royal Milk is the only producer of infant formula in Canada, manufacturing quality products from Canadian cow and goat milk, ensuring the highest quality and nutritional value for our customers. We are an...

  • Program Manager

    6 days ago

    Kingston, Canada Queen's University Full time

    **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 &...

  • Production Manager

    6 months ago

    Kingston, Canada Frulact Full time

    **Who we are**: Frulact is an international business group, founded in Oporto in 1987. Currently, we are positioned as a top-ranked innovative player in the supply of added-value ingredients for the food and beverage industry, focusing on fruit preparations, plant-based dairy alternatives, liquid flavours, and other specialty ingredients. For more...

  • Adult Medicine Physician | Full Time

    4 weeks ago

    Kingston, Canada Calian Group Ltd. Full time

    Calian is proud to continue a long-standing contractual relationship with the Department of National Defence (DND) to provide healthcare services to the Canadian Armed Forces. Through the Health Care Provider Contract, Calian employs health care professionals across Canada who are integral to supporting the health and wellbeing of our military...

  • Cardiologist Physician with Internal Medicine Focus

    4 weeks ago

    Kingston, Ontario, Canada APEX Heart Centre Full time

    About APEX Heart Centre: Thrive in a Community Outpatient Cardiology ClinicWe are committed to delivering high-quality care to our patients through compassion and collaboration. Our professional team flourishes in an environment where patient care and longevity are our top priorities.Job Overview:As a physician at APEX Heart Centre, you will provide care to...

  • Research Assistant

    8 months ago

    Kingston, Canada Queen's University Full time

    **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 &...

  • Research Assistant

    8 months ago

    Kingston, Canada Queen's University Full time

    Research Assistant 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,...

  • Cancer Research Study Coordinator

    2 months ago

    Kingston, Canada Queen's University Full time

    Cancer Research Study Coordinator 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 &...

  • Program Manager

    6 days ago

    Kingston, Canada Queen's University Full time

    Program ManagerAbout Queen's UniversityQueen’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 &...

  • Financial Operations and Administrative Coordinator

    6 months ago

    Kingston, Canada Queen's University Full time

    **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 &...

  • Eastern Ontario Network

    7 months ago

    Kingston, Canada Queen's University Full time

    Eastern Ontario Network (EON) Research Associate 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,...

  • Eastern Ontario Network

    7 months ago

    Kingston, Canada Queen's University Full time

    **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 &...