Supervisor Clinical Affairs

21 DexCom Malaysia Sdn Bhd; Penang; On-site; MYR 180,000 - 320,000; Full time

Benefits offered by this job

Travel 15–25%

Job summary

Dexcom seeks a Senior Clinical Affairs/Operations leader to oversee sponsor-investigator studies from start-up to close-out. You will supervise a team of Clinical Research professionals, maintain study documentation, and collaborate with cross-functional stakeholders to ensure timelines, regulatory compliance, and high-quality data across global trials.

The role requires a Bachelor’s degree in Life Sciences or related field, 10+ years in Clinical Affairs/Operations, active PI eligibility, and

Qualifications

• Bachelor’s degree with 5-8 years of industry experience
• Active healthcare practitioner license and eligibility to serve as Principal Investigator
• Strong project management and stakeholder engagement capabilities
• Experience leading global clinical research teams and cross-functional collaboration
• Knowledge of GCP, ICH guidelines, regulatory requirements, and risk management

Responsibilities

• Lead and oversee sponsor-investigator clinical studies from start-up to close-out
• Supervise and develop a team of Clinical Research professionals
• Create and maintain study documentation, CRFs, IRB submissions, and training materials
• Plan, execute, and monitor clinical studies with cross-functional stakeholders
• Establish study timelines, deliverables, and operational milestones
• Oversee recruitment, visits, regulatory documentation, data collection, and study close-out
• Ensure compliance with study protocols, GCP, ICH guidelines, and SOPs
• Identify and document adverse events, protocol deviations, and risks
• Drive continuous improvement and performance metrics across clinical operations
• Build relationships with IRBs, healthcare professionals, regulators, and KOLs

Education

Bachelor's degree in Life Sciences, Nursing, Pharmacy, Healthcare, or related discipline

Job description

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.

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.

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 elevate 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

AI in Hiring Notice

We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people. At Dexcom, we are committed to providing a fair and inclusive recruitment process, and welcome candidates of all genders and gender identities to apply. If any wording in this description appears unintentionally gendered or exclusionary, please be assured this is not intentional. Should a reasonable accommodation be necessary to aid a disability, requests should be sent to Dexcom Talent Acquisition at [e-mail].

Since 1999, Dexcom has simplified and revolutionized diabetes management, positively impacting millions worldwide. At Dexcom, we're more than just a medical device company; we are a collective of visionary thinkers, trailblazers, and problem solvers. Our mission transcends the ordinary. We aim to revolutionize healthcare, one groundbreaking technology at a time.