Director, Clinical Operations Asset Lead

GSK•Mississauga, ON

3d•$189,750 - $316,250•Hybrid

About The Position

The Clinical Operations Asset Lead is the single point of accountability for clinical operations delivery across the full asset lifecycle. Representing Global Clinical Operations at the asset level, the COAL sets and delivers the program‑level operational strategy that enables execution of the scientific vision. Working in close partnership with clinical, biostatistics, and functional experts, the COAL drives informed decision‑making, provides strategic leadership to Study Delivery Teams, and ensures high‑quality, on‑time delivery—while retaining full accountability for overall asset outcomes. This COAL may take on responsibilities across both early and late phase, depending upon demand in our RIIRU portfolio.

Requirements

Bachelor’s degree in general science or life/health related Science Degree
Extensive portfolio‑level strategic experience leading and delivering complex clinical research programs or equivalent initiatives with significant business impact.
Expert‑level experience across end‑to‑end clinical development and the regulatory landscape, enabling proactive, innovative strategic guidance and independent leadership of complex cross‑functional teams.
Proven experience navigating and strategizing across multiple regulatory pathways potentially pursued simultaneously for different indications.
Ability to develop and execute integrated strategic plans across multiple streams and indications for one large asset or multiple interdependent assets
Excellent leadership skills building and managing matrixed teams, promoting motivation and empowerment of others to accomplish individual, team and organizational objectives within highly complex and high-pressure environments, while maintaining visibility at a senior level.
Excellent influencing and stakeholder management skills at all levels of the organization (including SVP and C-level).
Competent in working with complexity and uncertainty within the external regulatory environment (e.g. FDA, EMEA)

Nice To Haves

Masters’s Degree in General Science or life/health related Science Degree or MBA
Preferred experience leading or contributing to operational integration aspects of BD deals
Demonstrated cross-functional collaborator with effective communication skills and experience in building networks and influencing partners and stakeholders at all levels of the organization.

Responsibilities

Contribute to the Clinical Development Plan (CDP) and Integrated Evidence Plan (IEP) across Research, Development, and LCM
Ensure study designs are operationally feasible, regionally compliant, cost‑effective, and deliver high‑quality data
Provide protocol‑level operational input and support amendments through governance review
Lead and own the asset‑level resourcing strategy (in‑house vs outsourced)
Approve vendor selection, contracting, and oversight in line with GSK standards
Serve as escalation point for critical operational, quality, and GCP issues
Lead cross‑functional coordination to ensure inspection readiness and high‑quality study delivery
Ensure transparent communication of risks, issues, and successes across GCO
Own asset‑level delivery plans, scenario modeling, and budget forecasts
Drive innovative, patient‑centric and efficient approaches to study execution
Represent Clinical Operations at governance boards and support clinical filing activities
Own the asset‑level risk register and mitigation strategy using Quality by Design
Ensure accurate, current operational data in GSK systems until transition to study teams
Lead internal and external stakeholder engagement across the asset