Supervisor Clinical Affairs

Dexcom Inc.; Penang; On-site; MYR 120,000 - 180,000; Full time

Benefits offered by this job

Impactful work

Lead a global team

Collaborative culture

Professional development

Job summary

Dexcom Inc. in Penang, Malaysia, is seeking a Clinical Affairs Supervisor to lead sponsor-investigator studies from study start-up through close-out.

You will supervise and develop a team of clinical research professionals, ensuring study execution, quality, and regulatory compliance across global trials. You will collaborate with cross-functional stakeholders, establish timelines and milestones, manage adverse events and risks per GCP/ICH guidelines, and drive continuous improvement in clinical

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, Healthcare, or related discipline.
• 10+ years of Clinical Affairs and Clinical Operations experience within medical device, pharmaceutical, or CRO industry.
• Knowledge of GCP, ICH guidelines, regulatory requirements, quality systems, and risk management.
• Active healthcare practitioner license and eligible to serve as a Principal Investigator (RN, MD, PharmD, or equivalent).
• Demonstrated success leading and developing clinical research teams in a global environment.
• Strong project management skills and ability to manage multiple priorities in a fast-paced environment.
• Exceptional written and verbal communication skills and ability to engage with stakeholders across cultures and functions.
• Proficiency in clinical trial systems and study management tools.
• Fluent in English; additional Asian language proficiency is advantageous.
• Highly organized, detail-oriented, and capable of driving operational excellence.
• Experience with CGM technologies and diabetes management is preferred.

Responsibilities

• Lead sponsor-investigator clinical studies from study start-up through study close-out.
• Supervise and develop a team of Clinical Research professionals responsible for study execution and trial management.
• Create and maintain study-related documentation, including source documents, CRFs, IRB submissions, clinical training materials, and study tools.
• Partner with Clinical Affairs leadership and cross-functional stakeholders to plan, execute, and monitor clinical studies.
• Establish and track study timelines, deliverables, and milestones to ensure successful trial execution.
• Oversee subject recruitment, study visits, regulatory documentation, data collection activities, and study close-out processes.
• Ensure studies are conducted in accordance with study protocols, GCP, ICH Guidelines, applicable regulations, and Dexcom SOPs.
• Identify, document, and escalate adverse events, serious adverse events, protocol deviations, and other study risks as required.
• Establish performance metrics and quality benchmarks while driving continuous improvement initiatives across clinical operations.
• Build and maintain strong working relationships with internal stakeholders, IRBs, healthcare professionals, regulatory agencies, and key opinion leaders.

Skills

Leadership

Project management

GCP knowledge

ICH guidelines

Regulatory know-how

Study management

Stakeholder engagement

English proficiency

Quality/risk management

Education

Bachelor’s degree in Life Sciences or related field

Tools

CTMS

eCRF systems

Job description

Meet the Team

At Dexcom, our mission is to empower people to take control of their health through innovative continuous glucose monitoring technology. The Clinical Affairs team plays a critical role in advancing this mission by generating high-quality clinical evidence that supports product innovation, regulatory compliance, and patient outcomes.

As a Clinical Affairs Supervisor, you will lead a team responsible for executing sponsor-investigator clinical studies. You'll have the opportunity to collaborate with cross-functional teams, clinical experts, and key stakeholders while driving operational excellence and continuous improvement within clinical research activities.

Where You Come In

• You will lead and oversee sponsor-investigator clinical studies from study start-up through study close-out.
• You will supervise and develop a team of Clinical Research professionals responsible for study execution and trial management.
• You will create and maintain study-related documentation, including source documents, case report forms (CRFs), IRB submissions, clinical training materials, and study tools.
• You will partner with Clinical Affairs leadership and cross-functional stakeholders to plan, execute, and monitor clinical studies.
• You will establish and track study timelines, deliverables, and operational milestones to ensure successful trial execution.
• You will oversee subject recruitment, study visits, regulatory documentation, data collection activities, and study close-out processes.
• You will ensure studies are conducted in accordance with study protocols, Good Clinical Practice (GCP), ICH Guidelines, applicable regulations, and Dexcom SOPs.
• You will identify, document, and escalation adverse events, serious adverse events, protocol deviations, and other study risks as required.
• You will establish performance metrics and quality benchmarks while driving continuous improvement initiatives across clinical operations.
• You will build and maintain strong working relationships with internal stakeholders, Institutional Review Boards (IRBs), healthcare professionals, regulatory agencies, and key opinion leaders.

What Makes You Successful

• You have a Bachelor's degree in Life Sciences, Nursing, Pharmacy, Healthcare, or a related discipline.
• You have 10+ years of Clinical Affairs and Clinical Operations experience within the medical device, pharmaceutical, or Clinical Research Organization (CRO) industry.
• You possess comprehensive knowledge of clinical trial design, Good Clinical Practice (GCP), ICH guidelines, regulatory requirements, quality systems, and risk management practices.
• You hold an active healthcare practitioner license and are eligible to serve as a Principal Investigator (RN, MD, PharmD, or equivalent).
• You have demonstrated success leading and developing clinical research teams in a global environment.
• You have strong project management skills with the ability to manage multiple priorities in a fast-paced environment.
• You have exceptional written and verbal communication skills and can effectively engage with stakeholders across diverse cultures and functions.
• You are proficient in clinical trial systems, clinical databases, and study management tools.
• You are fluent in English; additional Asian language proficiency is considered an advantage.
• You are highly organized, detail-oriented, and capable of driving operational excellence through continuous improvement.
• You demonstrate strong leadership, professional integrity, sound judgment, and the ability to build collaborative relationships.
• Experience with continuous glucose monitoring (CGM) technologies and diabetes management is preferred.

What You'll Get

• A front-row opportunity to contribute to innovative clinical research that improves the lives of people living with diabetes.
• The chance to lead and develop a high-performing clinical operations team within a growing global organization.
• Opportunities to collaborate with global cross-functional partners, healthcare professionals, and industry experts.
• A culture that values innovation, continuous learning, collaboration, and operational excellence.
• Meaningful work supporting groundbreaking technology that positively impacts patients worldwide.

Travel Required

• 15-25%

Experience and Education Requirements

• Typically requires a Bachelor’s degree with 5-8 years of industry experience
• Informal management/ team lead experience

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