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 Program Management functions to ensure smooth information flow between departments. The D/AD will primarily be responsible for the design and execution of clinical trials at ProteinQure and will present or oversee the presentation of progress and data to members of the Management Team at ProteinQure.

The successful candidate must have the ability to multitask and function effectively in a fast-paced environment. They must be able to develop strong interpersonal relationships and work with internal and external stakeholders to effectively meet the temporal, quality and financial goals for any clinical studies. A key part of the job is managing external collaborations and contract organizations. The D/AD may be asked to manage internal personnel as appropriate but that cannot be guaranteed.

This job posting is to fill an existing position. Artificial intelligence may be used to assist in the initial screening of resumes for this position. This process is supervised by a human, and hiring decisions are not made solely by artificial intelligence.

Key responsibilities include:

• 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 3^rd 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.

Required Knowledge, skills and abilities

• Degree in scientific discipline and at least 10+ years of experience in medicine or pharmaceutical development, including clinical trial operational experience and 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