Clinical Project Lead/Sr. Lead/Associate Director/Director New Toronto, Ontario, Canada

2 weeks ago

Toronto, Ontario, Canada Tbwa ChiatDay Inc Full time
At ProteinQure, we have built the best computational platform for peptides that target extracellular targets. Our mission is to help 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. Our Phase I consortium will include the best sites in North America and begin in Q3 2025. Our other internal programs focus on using peptides as delivery vehicles 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 Clinical Project Lead to manage operations for our Phase 1A/1B clinical trial in oncology and manage CRO interactions. This individual will be a core part of the clinical team and report to the VP of Translation and Development.

The Clinical Project Lead/Sr. Lead/Associate Director/Director (Candidate) is responsible for leading various functions to support clinical trials with ProteinQure's compounds. 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 Regulatory, Quality, CMC, and Program Management functions to ensure smooth information flow between departments. The Candidate will primarily be responsible for the execution of clinical trials at ProteinQure including clinical site interactions and CRO management 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 clinical studies. A key part of the job is managing external collaborations and contract organizations. The Candidate may be asked to manage internal personnel as appropriate. Title shall be commensurate with experience.

Key responsibilities include:

- Accountable for the delivery of assigned clinical trial budget, timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support trial and/or program objectives.
- Lead and oversee execution of clinical trials, including first-in-human trials, in compliance with ICH/GCP, local regulations, and SOPs.
- 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 and trial management plans for the trial.
- Be the key interface for and manager of the performance of clinical vendors/CROs.
- Responsible for representing the Clinical Department on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures.
- Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports, and other documents and plans as appropriate.
- Establish and monitor trial and program metrics, including enrolment rates, compliance, and data completion.
- 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.
- Collaborate on and contribute to inspection readiness activities to support audits and regulatory inspections related to clinical trial conduct.
- Manage invoice and budget tracking for individual trials and provide input into budget forecasting activities.
- Represent the 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 clinical operations and functional area expertise.

Required Knowledge, skills and abilities

- Degree in scientific discipline and at least 5 years of clinical trial operational experience.
- Strong knowledge of Good Clinical Practice guidelines including ICH E6.
- 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 propose 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.

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