Senior Director, Regional Clinical Study Management

BeOne Medicines

. Provide inspirational leadership, proactive management, and feedback-oriented mentorship to clinical study managers .

Posted 9/23/2026full-timeRemote • CanadaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in clinical operations management, including leadership of clinical study teams, strategic decision-making, and compliance with regulatory standards. Proven ability to optimize study feasibility and manage regional clinical portfolios effectively.

Highest-signal resume keywords

Clinical Operations ManagementLeadership in Clinical ResearchRegulatory Compliance (ICH/GCP)Project Planning ApplicationsTeam Leadership in Clinical Functions

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study ManagementData Collection and Query ResolutionBudget ManagementSOP DevelopmentTrial Feasibility Optimization

Soft Skills

Inspirational LeadershipMentorship and CoachingCollaboration with StakeholdersFeedback-Oriented Management

Tools & Technologies

MS OfficeProject Planning Applications

Industry Keywords

BiotechPharmaceuticalCROClinical ResearchInspection Readiness

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Provide inspirational leadership, proactive management, and feedback-oriented mentorship to clinical study managers
Lead assigned clinical study portfolios and designated therapeutic areas or assets
Deliver regional studies or portfolios with inspection readiness, within agreed timelines and budget
Act as regional lead for studies across indications or programs
Lead regional clinical operations teams and serve as escalation point for regional issues
Align regional resources and deliverables with portfolio goals
Develop regional tools, work instructions, and SOPs
Lead regional clinical operations strategy and decision-making
Collaborate with regional stakeholders and provide portfolio progress updates to senior management and Global Clinical Study Managers
Lead cross-departmental teams and develop cross-functional strategies
Oversee clinical study planning and management from feasibility through closeout
Optimize trial feasibility, country allocation, and site selection
Coach and mentor regional study managers and CRAs
Provide regional input on clinical supplies, drug inventories, labels, regulatory approvals, and comparator reimbursement
Drive regional data collection, data entry, and query resolution
Oversee Clinical Study Report planning and execution as required
Ensure compliance with protocols, SOPs, ICH/GCP, and applicable regulations
Maintain inspection readiness throughout the study lifecycle
Manage regional vendor needs, investigator fees, site payments, patient travel reimbursement, resources, headcount, and budgets
Interview, line manage, and evaluate regional clinical study managers
Conduct performance appraisals and support professional development plans

Requirements

What you’ll need

Bachelor's degree in a scientific or healthcare discipline and 12+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry
Alternatively, preferably a master's degree in a scientific or healthcare discipline and 8+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry
Proven experience in clinical research
Relevant experience as team lead in clinical functions
Experience across multiple studies preferred
Proficiency with MS Office and project planning applications
Ability to travel as required by business need

Benefits

Comp & perks

Equal opportunity employer
Travel may be required as per business need