Commercial Study Lead

Canadian Nuclear Laboratories • Full-time • Chalk River Laboratories, Ontario, CA • 2w ago

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? 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!

Acting as the single point of contact between the Business Development Technical Director of Health and sponsor/clients.
Leading and coordinating pre-clinical commercial studies, including regulatory toxicology GLP studies and non-GLP studies.
Developing Study Plans and ensuring 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).
Directing analysis of data, leading preparation of final reports, ensuring compliance with regulatory requirements, and submitting 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, leading or assisting 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.
Leading sponsor/client visits relating to studies assigned to them.
Interfacing with Sponsors, Vendors, Contributing Scientist, other CNL service departments.
Troubleshooting and resolving assay or technical issues in the laboratory when scientific expertise is needed.
Directing methods development/validation studies, assisting in the development of new technologies or enhancing existing ones, and assisting in marketing new capabilities.
Other duties as assigned by your manager.

What we are looking for:

Education
- At minimum, bachelor’s degree in biology (B.Sc.) or related biological field from a university of recognized standing; OR membership in a scientific professional organization authorized by statute to establish qualification for membership in that organization.
- A master’s degree (M.Sc.) in a similar biology related field is preferred.
- Project management (PMP) certificate/accreditation is considered a great asset.
Experience
- Comprehensive understanding of peculiarities of Radiopharmaceutical drug development, and FDA/Health Canada drug registration requirements.
- Proven ability to lead projects in a dynamic, collaborative environment while meeting client schedules.
Knowledge, Skills & Abilities
- Excellent communication skills (verbal and written).
- Strong understanding on the pre-clinical drug development pipeline, including knowledge on typical in vivo drug evaluation methodologies.
- Familiarity and ability to work in accordance with quality control and quality assurance management programs (specifically GLP).
- Highly skilled in systematic literature reviews and data extraction, data interpretation, and writing reports.
- Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.
- Excellent presentation skills and experience working in a cross functional team and matrix environment.
- Strong communication skills, verbally and in technical writing at all levels inside and outside the organization.
- Excellent computer skills and familiarity with Microsoft Office Suite, including the ability to learn a validated system.
- Proactive, innovative, with good problem-solving skills.
Security Clearance Eligibility Required
- Reliability Status with Site Access Security Clearance (SASC), which has a minimum requirement of 3 years of verifiable history in Canada, Australia, New Zealand, the United States and/or the United Kingdom. CNL implements security screening in accordance with the Treasury Board of Canada Secretariat's “Standard on Security Screening” and the “Policy on Government Security.”

Why CNL?

Does working with a team across Canada to advance nuclear science and technology for a clean and secure world speak to you? We're reinventing ourselves to be the pacesetters so we can lead the charge in solving the problems that matter, like building the next generation of clean nuclear and hydrogen energy solutions, developing new and better-targeted cancer treatments, and continuing to lead the world in environmental remediation.

We offer a complete total rewards package :

Paid time off (vacation, sick, floater & personal);
Benefits effective day one, that’s right, no waiting period;
Tuition support
and a pension!

Do Our Priorities Resonate with You?

Clean energy for today and tomorrow.
Restore and protect the Environment.
Contribute to the health of Canadians.

Location :

This role is a fully onsite role that requires the employee to primarily work at CNL’s Chalk River Laboratory site, with only occasional opportunities to work remotely, if desired by the employee. CNL’s Chalk River laboratory is nestled in the Ottawa Valley and affords our employees an area that is environmentally pristine with extensive forests, hills and numerous small lakes, all of which support a variety of wildlife typical to the southern edge of the Canadian Shield. Many surrounding towns, such as Pembroke, Petawawa, and Deep River, provide you with unparalleled outdoor adventures at your doorstep!

CNL is committed to providing an atmosphere free from barriers that promotes equity, diversity and inclusion in achieving our mission. CNL welcomes and celebrates employees, stakeholders and partners of all racial, cultural, and ethnic identities. Read here further on our DE&I Commitment.

CNL also supports a workplace environment and a corporate culture that is built on our Core Values: Respect, Teamwork, Accountability, Safety, Integrity and Excellence which encourage equitable employment practices and career prospects inclusive of accommodations for all employees.

CNL is committed to being an equal-opportunity employer. If you require accommodation measures during any phase of the hiring process, please indicate via our ATS when applying. All information received in relation to accommodation requests will be kept confidential.

The Chalk River Laboratories site is located on the unceded and unsurrendered territory of the Algonquin Anishinaabe people. As an organization, CNL recognizes and appreciates their historic connection to this place. CNL also recognizes the contributions that First Nations, Métis, Inuit and other Indigenous Peoples have made, both in shaping and strengthening this community in particular, and this province and country as a whole.

#LI-ONSITE

Apply