[Japan] Associate Manager, Clinical Operations Japan/Asia

Santen is a pharmaceutical company with a 130-year history specializing in ophthalmology. As a global company originating from Japan, we have bases in over 60 countries, providing various innovative treatments and digital solutions for eye health, and addressing social issues related to vision for people around the world.

The Japan Asia Clinical Development Group is the core organization responsible for the execution of clinical trials in Santen Pharmaceutical's development projects. From study startup to completion, we lead overall clinical trial operations, including site selection, vendor management, risk management, quality assurance, and study progress management. We collaborate with experts in various regions, including Japan and Asia, bringing together diverse knowledge and experience to drive world-class clinical trials. Our mission is to pave the way for the future of ophthalmology through patient-centric development.

• Independently formulate clinical development plans, clinical trial protocols, and monitoring plans in accordance with the clinical development strategy to collect various information such as efficacy evaluation and regulatory requirements related to assigned projects.
• Appropriately manage CRAs/vendors to collect data ensuring scientific validity, ethics, and reliability within deadlines.
• Manage and analyze clinical trial progress, and formulate/execute countermeasures to ensure rapid progress of clinical trials.
• Create drafts of clinical trial-related documents, such as Clinical Study Reports, based on the collected data ensuring scientific validity, ethics, and reliability.
• Build good relationships of trust with medical experts, etc., through the implementation of clinical trials.

Requirements

• Deep knowledge of ICH-GCP and related regulatory requirements.
• Understanding of clinical trial design, endpoints, efficacy evaluation, etc.
• Experience in monitoring practice and the ability to formulate study operation strategies.
• Experience in CRO and vendor management.
• Ability to comprehensively manage study progress, quality, budget, and risk.
• Ability to perform tasks such as document preparation and communication in English.

Career Development at Santen

A career at Santen will be an opportunity for you to make a difference. Through the long-term vision shown in "Santen2030," Santen aims to become a social innovator that meets the social and economic needs of people with visual impairments. To achieve this, we leverage diverse talents with team members around the world and provide flexible working styles and an inclusive work environment. As a result, we discover new solutions and promote understanding of patients and innovation in treatment.

The Santen Group is an Equal Opportunity Employer. We are committed to building diverse teams and providing a safe and inclusive physical and virtual workplace for every team member. All employment is based on business needs, role requirements, and individual skill sets, regardless of race, color, ethnicity, origin/ancestry, religion, sexual orientation, gender, gender identity/expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.