Clinical Research Director (Research Institute)

RESEARCH INSTITUTE OF THE MUHC
The Research Institute of the McGill University Health Centre (RI-MUHC) is a world-renowned biomedical and hospital research centre. Located in Montreal, Quebec, the Institute is the research arm of the McGill University Health Centre (MUHC) affiliated with the Faculty of Medicine at McGill University. The RI-MUHC is supported in part by the Fonds de recherche du Québec - Santé (FRQS).

Position summary
The post provides leadership and overall oversight to support and facilitate human and clinical research in the Research Institute of the McGill University Health Centre (RI-MUHC), especially in the Centre for Innovative Medicine (CIM). The post reports directly to the executive leadership (Executive Director/Chief Scientific Officer and the Deputy Executive Directors/Chief Scientific Officers) of the RI-MUHC.

Clinical and translational research are priorities in the RI-MUHC and involves research in humans such as first-in-human studies, observational studies and clinical trials..

The CIM is a facility that enables clinicians and clinician-scientists to conduct clinical research across multiple diseases from pediatrics to adults. Research in the CIM spans first-in-human studies through phase I to phase III clinical trials (industry-and investigator-sponsored trials). The CIM offers access to clinical research staff, and a full range of equipment and services in an environment dedicated to clinical research. It houses interview and examining rooms to see research patients, and multiple research platforms, including human cardiorespiratory and metabolic physiologies, medical imaging, surgical suites, simulation, specimen processing laboratory, biobanking and other facilities.

This post oversees clinical research in general in the RI-MUHC.

General Duties
• Lead of a large team of investigators to support and facilitate clinical research and trials across the MUHC,
• Co-lead a work group in clinical research of a strategic plan for clinical research at the RI-MUHC, write and lead the implement (planning, monitoring of progress and implementation, and business plan),
• Oversight of clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed,
• Promotion of translational research, first-in-human research and pharma-sponsored trials,
• Building partnerships and supporting innovation with industry and to attract new clinical trials (Phases I, II, III, and post-marketing),
• Growth of the clinical research portfolio, including investigator-initiated clinical studies and trials,
• Provision of clinical, scientific and development expertise to grow innovation and business initiatives,
• Ensure standardization and harmonization of the clinical research practice across the MUHC and CIM,
• Work to better integrate research services and facilities of the CIM to the entire clinical research community at the RI-MUHC,
• Work in collaboration with the leadership of competitive clinical grant-funded programs, such as pan Canadian consortium of clinical trials (ACT) and the Clinical Trial Training Platform (CANadian Consortium of the Clinical Trial TRAINing Platform: CANTRAIN),
• Collaborate with external stakeholders such as study investigators, key opinion leaders as needed for clinical trial and program,
• Establish and support collaborative links between the CIM, Centre for Translational Biology (CTB) and Centre for Centre for Health Outcomes Research (CORE) to facilitate translational, first-in-human studies and clinical research and trials,
• Participate as an active member in internal and external committees, and provide reports, as appropriate,
• Provide clinical leadership in preparation for and interactions with Regulatory Authorities,
• Review sections of clinical study reports and regulatory submission documents, regulatory agency briefing packages, etc.,
• Provide expertise and act as a reference for all medical operational activities related to the assigned projects/studies,
• Plan and facilitate the integration of clinical practice settings and advance knowledge mobilization to promote evidence-based health care.

• MD required with experience in clinical research,
• At least five years of experience in a leadership position in a clinical research facility, particularly phase 1-3 clinical trials,
• Proven leadership skills and the ability to successfully oversee multi-disciplinary teams,
• Professional experience and demonstrated track-record with investigator-initiated clinical and/or industry-supported trials,
• Known for ability to collaborate with internal stakeholders, such as Clinical Operations, Regulatory Affairs, etc., as well as with external collaborators, such as study investigators and their staff, Key Opinion Leaders, CROs and vendors,
• A deep understanding on Good Clinical Practice (GCP) is necessary (has conducted trials in a GCP/ICH compliant environment), Declaration of Helsinki, International Conference on Harmonization requirements and Nagano,
• Member in good standing order of Council of Physicians, Dentists and Pharmacists (CPDP),
• Ability to work effectively within a team in a fast-paced changing environment,
• Effective in building relationships and networks with others,
• Ability to anticipate and timely escalate issues and to define appropriate action plans,
• Quality focused and well organized,
• Excellent spoken and written communication skills (French and English).

Status : Full-time
Pay Scale: Commensurate with education & work experience.
Work Shift: 8:30am., to 4:30pm., Monday to Friday, 35-hour workweek.
Work Site: Glen and Montreal General Hospital sites

Why work with us?

• 5 weeks’ vacation
• Paid time off between Christmas and New Year’s Day
• 13 paid statutory holidays
• 12 paid sick days, including 6 personal days
• Modular group insurance plan (including Gender Affirmation benefit)
• PPMP Pension Plan of Management Personnel https://lnkd.in/gisrCPw9
• Professional development courses
• Flex work options and much more

https://rimuhc.ca/careers

To learn more about our benefits, please visit http://rimuhc.ca/en/compensation-and-benefits

THIS IS NOT A HOSPITAL POSITION.

The Research Institute of the McGill University Health Centre hires on the basis of merit and is strongly committed to equity, diversity and inclusion within its community. We welcome applications from all qualified candidates who self-identify as members of racialized groups/visible minorities, women, Indigenous persons, persons with disabilities, ethnic minorities, and 2SLGBTQIA+ persons. We also welcome candidates with the skills and knowledge to productively engage with diverse communities. Persons with disabilities who anticipate needing accommodations for any part of the application process may confidentially contact, [email protected]