ProteinQure Inc
Biotechnology
AssociateDirector/DirectorDevelopmentClinical
Neural analysis suggests this role is
optimal for Director candidates.
“Associate Director/Director Development Clinical at ProteinQure Inc. Skills: Clinical trial operations, Clinical development, CRO management, Cross-functional leadership. Lead clinical operations for assets. Support translation and development of compounds”
Industry & Context.
Identify solutions; Resolve project conflicts; Resolve project issues
Legally able to work in Canada
What They're Looking For.
Must Have
Degree in scientific discipline, 10+ years experience in medicine or pharmaceutical development, Clinical trial operational experience, Leadership of Phase I/II trials, Knowledge of Good Clinical Practice guidelines, Experience managing full-service CROs, Experience managing multiple vendors, Experience with first-in-human or Phase trials, Safety oversight experience, Dose escalation monitoring experience, SAE/SUSAR coordination experience, Ability to lead and coordinate cross-functional project teams, Strategic and analytical thinking skills, Interpersonal skills, Ability to lead and manage multiple responsibilities, Identify functional constraints and solutions, Ability to coordinate timelines, Articulate status and issues effectively, Excellent English communications skills, Legally able to work in Canada
Nice to Have
Experience with clinical trial database (eCTD) establishment, Experience with electronic Case Report Form (eCRF) design and testing
What You'll Do.
Lead clinical operations for assets
Support translation and development of compounds
Ensure smooth information flow between departments
Design clinical trials
Execute clinical trials
Oversee presentation of progress and data
Develop interpersonal relationships
Work with internal and external stakeholders
Manage external collaborations
Manage contract organizations
Manage internal personnel
Deliver assigned clinical trial tasks
Manage clinical trial budgets
Manage clinical trial timelines
Manage clinical trial implementation
Manage clinical trial operations
Manage clinical trial resources
Oversee execution of key aspects of clinical trials
Ensure compliance with ICH/GCP
Ensure compliance with local regulations
Ensure compliance with SOPs
Lead implementation of procedures for CROs
Ensure harmonization of internal and external efforts
Oversee CRO performance
Establish quality metrics for CROs
Manage cross-functional project teams
Support milestone achievement
Manage trial/program issues
Manage trial/program obstacles
Develop operational strategy for trials
Develop implementation plans for trials
Develop management plans for trials
Execute operations for delegated aspects
Oversee delegated operations
Support selection of vendors/CROs
Manage performance of selected vendors/CROs
Ensure coordination between 3rd party vendors
Ensure coordination with clinical CRO
Ensure coordination with internal teams
Represent Clinical Department on project teams
Represent Clinical Department on vendor/CRO meetings
Ensure compliance with operational standards
Ensure compliance with operational procedures
Ensure compliance with laws
Contribute to drafting clinical documents
Review clinical documents
Provide input into clinical documents
Ensure appropriate resources are available
Resolve project conflicts
Resolve project issues
Establish trial metrics
Monitor trial metrics
Establish program metrics
Monitor program metrics
Monitor enrolment rates
Monitor data completion
Implement Risk Management Plans
Implement KPIs for clinical site performance
Implement KPIs for CRO performance
Implement KPIs for internal performance
Manage establishment of electronic Clinical Trial Database
Manage establishment of electronic Case Report Form design
Manage testing of electronic Case Report Form
Ensure pharmacovigilance systems are put in place
Coordinate activities for patient safety
Coordinate activities for regulatory reporting
Coordinate SAE/SUSAR reporting
Ensure prompt tracking of SAEs/SUSARs
Ensure proper tracking of SAEs/SUSARs
Ensure prompt reporting of SAEs/SUSARs
Ensure proper reporting of SAEs/SUSARs
Work on implementation of central biomarker testing
Work on management of central biomarker testing
Work on implementation of central sample testing
Work on management of central sample testing
Identify contractors for testing
Ensure proper collection of samples
Ensure proper shipment of samples
Ensure proper storage of samples
Lead inspection readiness activities
Support regulatory inspections
Manage invoice tracking for trials
Manage budget tracking for trials
Provide input into budget forecasting
Represent Company externally to Investigators
Represent Company externally to site staff
Represent Company externally to Key Opinion Leaders
Ensure good relations with Investigators
Ensure good relations with site staff
Ensure good relations with Key Opinion Leaders
Provide oversight to assigned CRAs
Provide oversight to assigned CTAs
Provide oversight to assigned Clinical monitors
Provide mentorship to assigned CRAs
Provide mentorship to assigned CTAs
Provide mentorship to assigned Clinical monitors
Provide operations support
Provide project management support
How You'll Work.
Team & Collaboration
Cross-functional project teams; Internal and external stakeholders; Management Team; Exp Bio; Regulatory; Quality; CMC; Program Management; Cross-functional project teams; Vendor/CRO operational meetings
Communication Scope
English communications; Verbal communication; Written communication; Articulate status; Articulate issues; Articulate solutions
Process & Methodology
Project management support, Program management support
Full Job Description
About ProteinQure At ProteinQure, we have built the best computational platform for peptides that target extracellular targets. Our mission is to help to create a world where drugs are engineered, not discovered. We work on treatments for cancer and other indications while also partnering with industry leaders in drug discovery to generate novel therapeutics outside of the conventional chemical space. Our technology combines computational biophysical models with statistical and machine learning approaches to enable us to search across vast spaces of protein therapeutics. We have worked with three of the top 25 pharma companies and have validated our tools on multiple targets. We also have multiple internal programs, the most advanced is a First-in-Class peptide drug conjugate for TNBC, which is in a Phase 1 clinical trial including the best sites in North America. A second clinical program is expected within 3 years. Our other internal programs focus on using peptides as delivery vehicle for therapeutic payloads such as radioisotopes and siRNA. ProteinQure is a Series A-stage company and has raised its Series A round of USD $10M. We are looking for a Director or Associate Director of Clinical Development to run the clinical operations for assets in clinical studies. Position: Associate Director/Director Development Clinical Reports to: VP Translation and Development Status: Permanent Expected Compensation Range: $120,000 to 170,000 CAD annually, based on skills, qualifications, and relevant experience. The Director (D)/Associate Director (AD) Clinical Development is responsible for leading various functions to support clinical trials with ProteinQure’s compounds as well as supporting the translation and development of lead compounds towards the clinic. Within the Translation group, this position reports directly to the VP of Translation and Development, and will work closely with the CEO and Chief Medical Officer as well as Exp Bio, Regulatory, Quality, CMC and Prog
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