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Associate Director, Development Operations Global Study Support - Job Opportunity at Alexion Pharmaceuticals, Inc.

Mississauga, Canada
Full-time
Senior
Posted: February 22, 2025
Hybrid
CAD 140,000 - 180,000 annually based on location and experience level

Benefits

Hybrid work environment with 3 days minimum office presence
Professional development and training programs
Global exposure in pharmaceutical development
Career advancement opportunities within AstraZeneca group

Key Responsibilities

Lead development and implementation of global standards and processes for clinical operations
Drive cross-functional collaboration and process improvement initiatives
Serve as Subject Matter Expert (SME) for clinical study management
Manage and maintain clinical study tools and documentation
Support team training and development initiatives
Provide strategic oversight for process standardization
Lead cross-functional reviews and best practice implementation

Requirements

Education

Bachelor's degree in clinical practice/health care, life sciences, or drug development

Experience

>10 years of clinical research experience, with 5 years in global clinical trials

Required Skills

Problem-solving and analytical thinking Leadership and mentoring abilities Cross-functional collaboration Process development and standardization Clinical research expertise Project management Communication and presentation skills

Certifications

PMP certification (desired but not required)
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Industry Trends

Increasing focus on standardization and efficiency in clinical operations due to rising trial complexity and costs Growing importance of digital transformation in clinical trial management Shift towards decentralized clinical trials requiring robust operational frameworks Integration of real-world evidence and adaptive trial designs demanding sophisticated operational support

Role Significance

Likely leads a team of 5-8 clinical operations professionals with matrix management of cross-functional teams
Senior leadership position with significant influence on global clinical operations and process standardization

Key Projects

Global process standardization initiatives Clinical operations technology implementation Training program development Best practice framework establishment Cross-functional efficiency improvement projects

Success Factors

Strong understanding of global clinical trial operations and regulatory requirements Ability to influence without direct authority in matrix organization Experience with change management and process improvement Deep knowledge of clinical research best practices Strong stakeholder management capabilities

Market Demand

High demand position due to increasing complexity of clinical trials and industry focus on rare diseases

Important Skills

Critical Skills

Clinical operations expertise with focus on standardization and efficiency Change management and stakeholder engagement capabilities Strategic thinking and process improvement orientation

Beneficial Skills

Experience with clinical trial management systems Knowledge of rare disease clinical development Understanding of global regulatory requirements Digital transformation expertise

Unique Aspects

Rare disease focus provides unique clinical operations challenges
Integration with AstraZeneca offers broader career opportunities
Strong emphasis on process standardization and efficiency
Global reach with local autonomy

Career Growth

2-4 years in role before advancement opportunity, depending on performance and organizational growth

Potential Next Roles

Director of Clinical Operations Head of Global Study Operations Senior Director of Development Operations

Company Overview

Alexion Pharmaceuticals, Inc.

Alexion, now part of AstraZeneca, is a leader in rare disease therapeutics with a strong focus on innovative treatments

Top-tier position in rare disease market with strong backing from AstraZeneca's global presence
Strategic Canadian operation supporting global clinical development initiatives
Innovation-focused environment with emphasis on collaboration and patient-centricity
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