Clinical Project Director/Associate Director

ProteinQure Inc•Toronto, ON

7h•CA$120,000 - CA$170,000

About The Position

ProteinQure is seeking a Director or Associate Director of Clinical Development to manage the clinical operations for assets in clinical studies. This is a permanent, full-time position with an expected annual compensation range of $120,000 to $170,000 CAD. The role reports to the VP of Translation and Development and will work closely with the CEO and Chief Medical Officer, as well as other functional groups, to ensure smooth information flow and effective execution of clinical trials. The successful candidate will be responsible for the design and execution of clinical trials, presenting progress and data to the management team, and managing external collaborations and contract organizations. The ability to multitask, function effectively in a fast-paced environment, and develop strong interpersonal relationships is crucial. This position may involve managing internal personnel, though this cannot be guaranteed. Artificial intelligence may be used in the initial screening of resumes, but hiring decisions are human-supervised.

Requirements

Degree in scientific discipline
At least 10+ years of experience in medicine or pharmaceutical development
Clinical trial operational experience
Leadership of Phase I/II trials
Strong knowledge of Good Clinical Practice guidelines including ICH E6
Demonstrated experience managing full-service CROs and multiple vendors from RFP through closeout
Experience with first-in-human or Phase I trials, including safety oversight, dose escalation monitoring, and SAE/SUSAR coordination
Proven ability to lead and coordinate cross-functional project teams spanning multiple functions
Strategic and analytical thinking skills to assimilate complex information and inform decisions
Strong interpersonal skills and the ability to positively influence and guide others both internally and externally
Demonstrated ability to lead and manage multiple responsibilities
Identify functional constraints and identify solutions
Ability to coordinate timelines with internal stakeholders and external vendors/partners
Ability to articulate status and issues effectively to management as well as possible solutions
Excellent English communications skills, both verbal and written
Legally able to work in Canada

Responsibilities

Accountable for the delivery of assigned clinical trial tasks including budgets, timelines, implementation, operations and resource management with a focus on quality, including making recommendations and decisions regarding operational strategies to support trials and/or program objectives.
Lead and oversee execution of key aspects of clinical trials, in compliance with ICH/GCP, local regulations, and SOPs.
For trials using external CROs, lead the implementation of procedures to ensure harmonization of internal and external efforts and oversight of the CRO, including the establishment of quality metrics to assure proper performance against the contract.
Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage trial/program issues and obstacles.
Develop operational strategy, implementation and management plans for assigned aspects of the trial.
Execute the operations and oversee those aspects delegated to others on the team.
Support the selection of vendors/CROs and work with the team managing the performance of any selected vendors/CROs doing work to support clinical studies aside from the main CRO running the study.
Ensure coordination of activities between 3rd party vendors, the main clinical CRO, and ProteinQure internal teams.
Responsible for representing the Clinical Department on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures as well as laws.
Contribute to the drafting of, review and provide input into relevant clinical documents such as the protocol, investigator brochure, ICFs, management plans, regulatory documents, clinical study reports and other documents as appropriate.
Ensure appropriate resources are available for the trial activities and resolve project conflicts and issues.
Establish and monitor trial and program metrics, including enrolment rates, TMF filing, compliance and data completion.
Work with management to implement Risk Management Plans and KPIs for clinical site performance, CRO performance, and internal performance.
Take a lead role on managing the establishment of the electronic Clinical Trial Database (eCTD) and the electronic Case Report Form (eCRF) design and testing including error checks.
Ensure pharmacovigilance systems are put in place for trials and coordinate activities to assure both patient safety and compliance with regulatory reporting requirements for SAEs/SUSARs.
Coordinate with the Chief Medical Officer, VP of Translation and Development, clinical CRO and regulatory personnel to ensure prompt and proper tracking and safety reporting.
Work with the team on implementation and management of any central biomarker or sample testing associated with trials, including identifying contractors for testing, ensuring proper collection, shipment and storage of samples, and analyzing and reporting the data.
Lead inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct.
Manage invoice and budget tracking for individual trial and provide input into budget forecasting activities.
Represent Company externally to Investigators, site staff, and Key Opinion Leaders. Ensure good relations are maintained with these groups.
Provide oversight and mentorship to any assigned Clinical Research Associates, Clinical Trial Associates or Clinical monitors by providing operations or project management support.