Global Medical Affairs Research Grant & Study Manager

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Santen Pharmaceutical

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🏭 Manufacturing

Pharmaceuticals • Healthcare • Manufacturing

Santen Pharmaceutical is a specialized company dedicated to ophthalmology, involved in the research, development, marketing, and sales of pharmaceuticals, over-the-counter products, and medical devices. As the market leader for prescription ophthalmic pharmaceuticals in Japan, Santen's products reach patients in over 60 countries. With a 130-year history, the company leverages its scientific knowledge and organizational capabilities to enhance the well-being of patients and society.

📋 Description

• Serve as the operational lead for the Investigator-Sponsored Studies (ISS) and research grants process, ensuring efficient administration and governance. • Coordinate the end-to-end lifecycle of ISS and research grant activities, from submission through study close-out. • Manage study contracts, milestones, budgets, payments, reporting requirements, and maintain accurate study documentation and tracking systems. • Facilitate cross-functional collaboration with Medical Affairs, Clinical Development, Compliance, Legal, Finance, and external stakeholders to support evidence generation activities. • Coordinate the planning, execution, oversight, and close-out of Medical Affairs-sponsored evidence generation programs, including Phase IV studies, observational research, registries, and real-world evidence initiatives. • Monitor study timelines, deliverables, operational performance, and ensure studies are conducted in compliance with GCP, regulations, ethical standards, and company procedures. • Support Phase III clinical development programs and drive alignment between development activities and post-approval evidence generation strategies. • Support expanded access, compassionate use, and other special research programs, ensuring appropriate coordination, documentation, and tracking. • Oversee external vendors and CROs, monitoring performance, quality, timelines, and budget adherence while proactively identifying and mitigating operational risks. • Contribute to process improvements, SOP development, inspection readiness, and initiatives that enhance operational efficiency, compliance, and transparency across evidence generation programs.

🎯 Requirements

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, Public Health, or a related scientific discipline (advanced degree preferred). • Minimum 5–8 years of experience in Clinical Research, Medical Affairs, Clinical Operations, Clinical Development, or Evidence Generation. • Experience managing clinical studies, including investigator-sponsored studies (ISS), Phase III/IV, observational, or post-marketing research. • Experience coordinating research grants and investigator-sponsored studies is highly preferred. • Strong knowledge of GCP, ICH guidelines, clinical research regulations, and compliance requirements. • Proven project management skills with the ability to manage multiple priorities and collaborate effectively with cross-functional stakeholders. • Experience working with CROs, investigators, academic institutions, and external research partners in a global environment. • Strong analytical, organizational, communication, and problem-solving skills, with a high level of attention to detail. • Proficiency with clinical trial management systems, grants management systems, electronic document management systems, and Microsoft Office.

🏖️ Benefits

• Competitive Salary: A market‑aligned base salary starting from 78.863 GBP – 108.436 GBP, depending on experience and location.