Commercial Study Lead

at  CANADIAN NUCLEAR LABORATORIES CNL

Are you looking for a position that provides essential support to the Canadian innovation industry?
Do you want to contribute directly to the health of Canadians?

INTRO

CNL is currently growing its pre-clinical commercial services to support the radiopharmaceutical industry that provides cancer therapy solutions.
Our Chalk River location is looking for a Commercial Study Lead to join our operational team with the aim of leading a multi-disciplinary team of scientific and technical staff on the delivery of pre-clinical in vivo radiopharmaceutical testing and regulatory toxicology studies.
We are seeking a Commercial Study Lead who will be responsible for overseeing study conduct of preclinical in vivo radiopharmaceutical testing and toxicology studies. The successful candidate will provide support throughout the commercial project lifecycle; from initial customer engagement, quotation, experimental design/preparation, study execution, and final reporting, to meet CNL and customer expectations. The incumbent will oversee the completion of commercial projects and provide coordination between groups. This role will also be instrumental in the implementation of operational excellence through continuous improvement.

What will you be doing!

• Act as the single point of contact between the Business Development Technical Director of Health and sponsor/clients.
• Lead and coordinate pre-clinical commercial studies, including regulatory toxicology GLP studies and non-GLP studies.
• Develop Study Plans and ensures that the Study Plan, including any amendments, is approved and follows the appropriate Standard Operating Procedures (SOPs) and regulatory agency guidelines (i.e., OECD, CCAC).
• Directs analysis of data, leads preparation of final reports, ensures compliance with regulatory requirements, and submits them to the client.
• Ensure that after completion of the study, the study plan, the final report, raw data and supporting material are archived.
• Liaise with commercial sponsors/clients, virtual and in-person meetings, lead or assist in project planning, and scope defining tasks.
• Provide input on the capabilities of the BRDF and facilities. Lead or assist proposal writing and budgetary estimates, including providing work plans, scheduling, materials, and labour estimates.
• Liaise with other internal teams to ensure resource availability when required.
• Lead sponsor/client visits relating to studies assigned to them.
• Interface with Sponsors, Vendors, Contributing Scientist, other CNL service departments.
• Troubleshoots and resolves assay or technical issues in the laboratory when scientific expertise is needed.
• May direct methods development/validation studies, assisting in the development of new technologies or enhancing existing ones, and assists in marketing new capabilities.
• Other duties as assigned by your manager.

• Act as the single point of contact between the Business Development Technical Director of Health and sponsor/clients.
• Lead and coordinate pre-clinical commercial studies, including regulatory toxicology GLP studies and non-GLP studies.
• Develop Study Plans and ensures that the Study Plan, including any amendments, is approved and follows the appropriate Standard Operating Procedures (SOPs) and regulatory agency guidelines (i.e., OECD, CCAC).
• Directs analysis of data, leads preparation of final reports, ensures compliance with regulatory requirements, and submits them to the client.
• Ensure that after completion of the study, the study plan, the final report, raw data and supporting material are archived.
• Liaise with commercial sponsors/clients, virtual and in-person meetings, lead or assist in project planning, and scope defining tasks.
• Provide input on the capabilities of the BRDF and facilities. Lead or assist proposal writing and budgetary estimates, including providing work plans, scheduling, materials, and labour estimates.
• Liaise with other internal teams to ensure resource availability when required.
• Lead sponsor/client visits relating to studies assigned to them.
• Interface with Sponsors, Vendors, Contributing Scientist, other CNL service departments.
• Troubleshoots and resolves assay or technical issues in the laboratory when scientific expertise is needed.
• May direct methods development/validation studies, assisting in the development of new technologies or enhancing existing ones, and assists in marketing new capabilities.
• Other duties as assigned by your manager