Director, Clinical Research

Job Summary:

The Director of Clinical Research will serve as the key point of contact for the global clinical R&D (CRD) team, providing leadership and strategic direction for clinical trials across the Asia-Pacific region. This role is responsible for planning, executing, and managing clinical research initiatives within CRD in alignment with global R&D priorities. The ideal candidate will have a hybrid clinical and regulatory skill set, extensive experience in clinical trial operations, and deep expertise in the ophthalmic industry. This role is ideal for a seasoned clinical research professional with a strategic mindset, strong clinical/regulatory expertise, and the ability to drive impactful clinical programs in ophthalmology.

Key Responsibilities:

Research Collaborations & Key Opinion Leader Engagement
• Establish and manage cooperative research agreements with key opinion leaders (KOLs) to drive scientific advancements, novel clinical endpoint development, and accelerate global R&D initiatives.
• Foster strong relationships with KOLs, investigators, and healthcare professionals to enhance clinical development strategies.
• Leverage scientific expertise to engage customers and stakeholders effectively.

Clinical Trial Leadership & Regional Support
• Act as the primary liaison between the global CRD team and Asia-Pacific regional clinical trials, ensuring seamless collaboration.
• Provide local support in the planning, execution, and operational aspects of Alcon initiated clinical studies.
• Oversee site selection, patient recruitment, data collection, and compliance with global and local regulatory requirements.

Regulatory Compliance & Submissions
• Maintain thorough knowledge of local regulations in the Asia-Pacific region, ensuring compliance with all clinical research activities.
• Lead the preparation, submission, and presentation of clinical data to local notified bodies and health authorities, as assigned.
• Serve as a subject matter expert on the clinical regulatory landscape, guiding cross-functional teams on regulatory best practices.

Clinical Study Execution & Reporting
• Plan, conduct, and manage clinical studies from protocol development to final reporting.
• Oversee clinical trial documentation, including study protocols, investigator brochures, informed consent documents, and clinical study reports.
• Ensure adherence to Good Clinical Practice (GCP) guidelines, ethical standards, and company policies.

Product & Franchise Expertise
• Possess in-depth knowledge of ophthalmic products. Broad knowledge across multiple franchises, including surgical, contact lenses and, vision care is a plus.
• Provide scientific and clinical insights to support product development, commercialization, and post-market surveillance.
• Work closely with marketing, medical affairs, and commercial teams to align clinical strategies with business objectives.

Key Qualifications & Experience:
• Advanced degree in Medicine, Optometry, Life Sciences, Pharmacy, or a related field (MD, PhD, MSc, or equivalent preferred).
• 12+ years of experience in clinical research within the ophthalmic or medical device industry.
• Proven expertise in clinical trial design, execution, and regulatory submissions in the Asia-Pacific region.
• Strong understanding of regional regulatory requirements, including interactions with health authorities and notified bodies.
• Experience working with global teams and cross-functional stakeholders.
• Excellent scientific communication, leadership, and problem-solving skills.
 

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