Project Manager, Pre-Clinical Pipeline Development

Title:

Project Manager, Pre-Clinical Pipeline Development

Reports to:

VP of Research and Translational Science

Location:

Remote, Canada or United States. Kiso Ji Biotechnology is headquartered in Montreal, Canada. May require travel to key sites.

Salary:

$95,000 – $150,000 CAD — see Compensation section below for full details.

Scope:

IND-enabling programs spanning multiple therapeutic modalities — mainly antibody-based biologics, but also cell therapies and small molecule candidates.

Organization:

Kiso Ji Biotechnology — multi-site organization with an international network of CRO and CDMO partners.

Kiso Ji Biotechnology is a drug development company with a pre-clinical pipeline spanning multiple therapeutic modalities. As the organization and its pipeline grow, establishing a robust project management function to support program advancement is a current priority — and this role is central to that effort.

The Project Manager, Pre-Clinical Pipeline Development is responsible for keeping the IND-enabling programs on track. You will own project timelines, coordinate between internal teams and external partners, follow up on CRO and CDMO deliverables, and ensure that no deliverable or milestone is overlooked and that timelines stay on track. The role reports to the VP of Research and Translational Science. Because we are still setting up our project management infrastructure, part of this job is building it as the programs run.

• Build and keep current the project timelines for all active IND-enabling programs, across all work streams, teams, and locations involved

• Proactively coordinate with all contributing teams and partners to ensure that responsibilities are clearly assigned, deadlines are tracked, and program progress does not lapse

• Be the day-to-day contact for CRO and CDMO partners — tracking deliverables, following up to prevent timelines from slipping, and escalating when needed

• Support the contracting process for all external partners and track SOW execution and milestone payments

• Coordinate with the in vivo Pre-Clinical and Discovery teams so that in-house study schedules stay aligned with the external program timeline

• Keep project dashboards, status reports, and meeting materials current and useful for scientific teams and leadership

• Track project spend against budget and flag variances for management review

• 4–8 years in drug development, directly coordinating or managing pre-clinical programs

• A solid understanding of biologic IND-enabling work — what the main study types are, how they sequence, and how CMC, toxicology, and assay development fit together

• Familiarity with the regulatory documents that pre-clinical teams generate — IND package sections, clinical trial submissions — and experience tracking their preparation against submission timelines

• Direct experience managing CRO and/or CDMO relationships — tracking deliverables against timelines, managing vendor accountability, and handling the situations that arise when schedules slip

• A life sciences degree (BSc, MSc, or PhD) and enough scientific background to follow a technical conversation and communicate meaningfully with study teams

• Familiarity with the documents involved in IND-enabling work — study reports, CMC packages, regulatory submissions — to coordinate their preparation, track their status, and ensure their timely completion

• Highly organized — able to hold multiple concurrent work streams and keep them all moving simultaneously

• Reliable and accountable — follows through on commitments, identifies issues proactively, and takes initiative to address them

• Direct and clear in how you communicate — in writing and in person, with colleagues and with vendors

• Experience working in environments where processes are still being defined, with the ability to contribute to building them while managing active programs

• Experience coordinating the generation of IND package documents — tracking what needs to be produced, by whom, and by when

• Familiarity with bispecific or multispecific antibody development and other therapeutic…