Associate Director, Clinical Trial Management

Thryv Therapeutics Inc. is a privately owned company based in Montreal, Quebec, with a laboratory located in Laval, Quebec. Thryv Therapeutics is pioneering a precision medicine approach to develop highly selective SGK1 inhibitors to treat Long QT Syndrome, heart failure, and atrial fibrillation, with potent and selective inhibitors of Serum Glucocorticoid Regulated Kinase.

OPPORTUNITY SUMMARY

The Associate Director / Clinical Trial Manager (CTM) is the primary point of contact to lead, manage, and coordinate the conduct of clinical trials in accordance with ICH-GCP and other applicable local regulations. You will maintain the quality and scientific integrity of clinical trials and actively collaborate with cross-functional internal and external partners to ensure timely delivery and budget execution of clinical trial results. 

KEY RESPONSIBILITIES

  • Planning, management, and oversight of clinical study execution in accordance with the program strategy, through leadership and engagement of the cross-functional study team 

  • Contribute to and/or develop study-specific materials (e.g., monitoring plan, RMP, study-specific training documents, TMF, etc.) 

  • Manage, oversee, and supervise applicable vendor activities (e.g., CROs, laboratories, core labs, equipment provisioning) 

  • Identify and facilitate resolution of cross-functional study-specific issues 

  • Provide updates regarding the study budget and obtain approval for budget deviations  

  • Manage submission and maintenance of central IRB documentation/approval 

  • Proactively raise any issues related to delivery, timelines, or budget to the study team as required 

  • Conduct on-site quality visits with CRAs where/when appropriate and support the maintenance of investigator site relationships 

  • Implement regulatory agency inspection readiness activities (e.g., TMF review) 

  • Support internal audit and inspection activities and contribute to CAPAs, including leading resolution of issues when appropriate (e.g., vendor management) 

  • Lead and continually support risk mitigation activities to ensure the study delivers to plan 

  • Maintain relevant therapeutic knowledge 

  • Triage and tailor communication from the study team to sites to ensure efficient and effective communication flow 

QUALIFICATIONS

  • Minimum BSc in life sciences; advanced degree (e.g., MSc, PhD) is an asset 

  • Minimum 2–3 years of clinical trial project management experience 

  • 7 years of work experience in life sciences or a medically related field, including 4 years of biopharmaceutical clinical research experience obtained while working on clinical trials in a biotech, pharmaceutical, or CRO company 

  • Experience in management and oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.) 

  • Experience in rare and cardiovascular diseases is preferred 

  • Knowledge of clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines 

EQUAL OPPORTUNITY WORKPLACE

Thryv Therapeutics Inc. is proud to be an equal opportunity employer. We are committed to equal employment opportunity regardless of race, colour, religion, sex, sexual orientation, gender identity, age, national origin, disability, and any other characteristic protected by law.

APPLY

Please send your resume and cover letter to admin@thryvtrx.com